AIDS
Conditions
Keywords
Chloroquine, Human Immunodeficiency Virus
Brief summary
The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of a HIV candidate vaccine after administration of one oral dose of chloroquine.
Detailed description
The Protocol Posting has been updated following Protocol amendment 1, October 2009.
Interventions
BIOLOGICALGSK Biologicals' HIV vaccine (732461)
1 dose intramuscular injection
DRUGChloroquine
One dose of 300 mg
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 52 Years
Healthy volunteers
Yes
Inclusion criteria
* A male or female between, and including, 18 to 52 years of age at the time of vaccination. * Written informed consent prior to any study related procedure on the subject. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Good general health without significant medical history or physical examination findings. * Negative for anti-HBc and anti-Hepatitis C Virus antibodies. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception until study completion. * Previous participation and completion of the study NCT00434512. * Cellular and humoral immune responder to vaccines administered in study NCT00434512. * Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.
Exclusion criteria
* Clinically significant laboratory value above normal range for blood urea nitrogen, creatinine, alanine aminotransferase and aspartate aminotransferase, or clinically significant laboratory value above or below normal range for Hemoglobin, as per investigator judgment. * Women who are pregnant or breast-feeding. * Receipt of live attenuated vaccines within 30 days of vaccination. * Receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) or allergy treatment with antigen injections (including a tuberculin skin test) within \<= 21days preceding and planned \<= 21 days following the study vaccine administration. * Receipt of blood products 120 days prior to vaccination. * Receipt of immunoglobulin 120 days prior to vaccination. * Subject has donated blood in the last 3 months. * Bleeding disorder that was diagnosed by a physician; e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first. * History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product. * History of serious allergic reaction to any substance requiring hospitalization or emergency medical care. * History of hypersensitivity against chloroquine or any components of the drug. * History of hypersensitivity against aminoglycosides. * Ophthalmologic findings at screening. * Previous administration of 4-aminoquinoline in the previous year or for a duration of more than 1 year. * History of Glucose-6-Phosphate Dehydrogenase deficiency. * History of hematopoietic disease. * History of Myasthenia gravis. * History of any serious neurological disorder or seizure. * History of immunodeficiency or immune-mediated disorders, including active psoriasis. * History of type I or type II diabetes mellitus including cases controlled with diet alone. * Thyroid disease including history of thyroidectomy and diagnoses requiring medication. * Asthma requiring daily steroid or long acting β-agonist prevention. * Unstable asthma defined as: * Sudden acute attacks occurring in less than three hours without an obvious trigger. * Hospitalization for asthma in the last two years. * Food- or wine-induced asthma. * Known sensitivity to sulfites or aspirin. * History of major congenital defect. * History of chronic fatigue syndrome or fibromyalgia. * History of malignancy. * Splenectomy. * Morbid obesity. * Clinically relevant hypertension. * Subjects with a history of, or current, alcohol or substance abuse. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Previous inclusion in a HIV vaccines trial other than study NCT00434512. * Subject is seropositive for HIV, as determined by the test results performed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At Day 14 | Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS). |
| Number of Subjects With Solicited Local Symptoms | During the 7 Day (Days 0-6) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Number of Subjects With Solicited General Symptoms | During the 7 Day (Days 0-6) post-vaccination period | Assessed solicited general symptoms were fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 up to Day 360) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs) | During the entire study period (from Day 0 up to Day 360) | Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events. |
| Levels of Haematological and Biochemical Parameters | At Day 0 | Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | At Day 0, 7, 14, 30 and 180 | Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS. |
| Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | At Day 0, 7, 14, 30 and 180 | Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ. |
| Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. |
| Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. |
| Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. |
| Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | At Day 0, 7, 14, 30 and 180 | Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ. |
| Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est). |
| Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est). |
| Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est). |
| Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | At Day 0, 7, 14, 30 and 180 | Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL). |
| Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. |
| Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS. |
| Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS. |
| Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. |
| Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. |
| Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est). |
| Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | At Day 0, 7, 14, 30 and 180 | Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est). |
Countries
Belgium
Participant flow
Pre-assignment details
Out of all the subjects planned for enrollment, only 28 were included in the analyses and hence started the study.
Participants by arm
| Arm | Count |
|---|---|
| GSK732461+Nivaquine Group Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine. | 13 |
| GSK732461 Group Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm. | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | GSK732461+Nivaquine Group | GSK732461 Group | Total |
|---|---|---|---|
| Age, Continuous | 25.1 Years STANDARD_DEVIATION 5.33 | 24.3 Years STANDARD_DEVIATION 3.73 | 24.67 Years STANDARD_DEVIATION 4.47 |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 13 | 15 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
Primary
Levels of Haematological and Biochemical Parameters
Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Time frame: At Day 180
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Within | 11 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Within | 11 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Below | 2 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Within | 10 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Below | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Below | 3 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Below | 2 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Within | 13 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Within | 12 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Below | 0 Participants |
Primary
Levels of Haematological and Biochemical Parameters
Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Time frame: At Day 30
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Within | 11 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Below | 2 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Within | 11 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Below | 3 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Within | 9 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Within | 9 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Within | 11 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Below | 2 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Within | 12 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Below | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Within | 15 Participants |
Primary
Levels of Haematological and Biochemical Parameters
Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Time frame: At Day 7
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Within | 11 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Below | 3 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Within | 10 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Unknown | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Within | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Within | 11 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Above | 2 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Below | 2 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Within | 10 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Below | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Below | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Within | 12 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Above | 2 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Unknown | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Below | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Within | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Below | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Above | 0 Participants |
Primary
Levels of Haematological and Biochemical Parameters
Among haematological and biochemical parameters determined were alanine aminotransferase \[ALT\], aspartate aminotransferase \[ASA\], basophils \[BASO\], creatinine \[CREA\], eosinophils \[EOS\], haematocrit \[HAEM\], haemoglobin \[HAEMO\], lymphocytes \[LYMPH\], monocytes \[MONO\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\], urea \[UR\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Time frame: At Day 0
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Above | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | LYMPH, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | MONO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Below | 2 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Below | 3 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Within | 11 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | EOS, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | NEU, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | PLA, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Within | 10 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Below | 1 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | RBC, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | BASO, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEM, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | UR, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | CREA, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Unknown | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Below | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ASA, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Within | 13 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | HAEMO, Within | 12 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | WBC, Above | 0 Participants |
| GSK732461+Nivaquine Group | Levels of Haematological and Biochemical Parameters | ALT, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Above | 2 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ALT, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | ASA, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Below | 4 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Within | 11 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | BASO, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | CREA, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Below | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | EOS, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEM, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | HAEMO, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Below | 3 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Within | 12 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | LYMPH, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | MONO, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Within | 13 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | NEU, Above | 2 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Within | 14 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | PLA, Above | 1 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | RBC, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Within | 15 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | UR, Above | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Unknown | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Below | 0 Participants |
| GSK732461 Group | Levels of Haematological and Biochemical Parameters | WBC, Within | 13 Participants |
Primary
Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs)
Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events.
Time frame: During the entire study period (from Day 0 up to Day 360)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK732461+Nivaquine Group | Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs) | 0 Participants |
| GSK732461 Group | Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs) | 0 Participants |
Primary
Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens
Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS).
Time frame: At Day 14
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At least 1 antigen, Day 14 | 1 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At least 2 antigens, Day 14 | 0 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At least 3 antigens, Day 14 | 0 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At least 4 antigens, Day 14 | 0 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At least 4 antigens, Day 14 | 0 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At least 1 antigen, Day 14 | 3 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At least 3 antigens, Day 14 | 0 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens | At least 2 antigens, Day 14 | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Day 0 up to Day 360)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK732461+Nivaquine Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK732461 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7 Day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Any Headache | 9 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal | 1 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 3 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal | 4 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Related Headache | 8 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 3 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Any Temperature | 8 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 9 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 9 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Related Temperature | 7 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal | 6 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Related Temperature | 9 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal | 3 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Any Headache | 13 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 14 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 3 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 11 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal | 5 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal | 0 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Related Headache | 10 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Any Temperature | 10 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 1 Participants |
| GSK732461 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Participants |
Primary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 7 Day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 3 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 13 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 3 Participants |
| GSK732461 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| GSK732461 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 1 Participants |
| GSK732461 Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 14 Participants |
| GSK732461 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 5 Participants |
| GSK732461 Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 6 Participants |
| GSK732461 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 2 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 8 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 3 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 5 Participants |
| GSK732461 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AEs | 13 Participants |
| GSK732461 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AEs | 2 Participants |
| GSK732461 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AEs | 8 Participants |
Secondary
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 30 | 71028.8 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 0 | 93.5 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 0 | 154.0 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 7 | 1599.4 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 180 | 27286.9 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 14 | 5069.8 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 180 | 27590.9 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 30 | 5148.5 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 0 | 394.6 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 180 | 1115.5 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 0 | 377.4 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 7 | 31465.3 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 7 | 31533.9 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 7 | 38430.3 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 14 | 78313.7 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 30 | 61372.0 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 14 | 113387.2 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 7 | 37905.7 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 14 | 79774.0 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 14 | 83863.4 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 30 | 77192.3 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 30 | 74791.3 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 0 | 217.8 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 180 | 42847.4 mEL.U/mL |
| GSK732461+Nivaquine Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 180 | 25141.1 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 180 | 40715.4 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 30 | 49619.3 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 180 | 27545.3 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 0 | 198.4 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 7 | 39928.9 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 14 | 59932.0 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 30 | 57653.6 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-RT, Day 180 | 26520.6 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 0 | 536.3 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 7 | 38621.8 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 14 | 63283.3 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 30 | 42709.2 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-Nef, Day 180 | 21371.8 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 0 | 98.9 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 7 | 1121.5 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 14 | 1763.3 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 30 | 1610.1 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 0 | 483.3 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 7 | 36200.9 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p24, Day 14 | 59655.5 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 0 | 330.2 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 7 | 39948.9 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 14 | 63951.9 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-F4co, Day 30 | 65633.5 mEL.U/mL |
| GSK732461 Group | Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations | Anti-p17, Day 180 | 639.0 mEL.U/mL |
Secondary
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D0 | 17.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D7 | 165.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D14 | 103.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D30 | 30.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D180 | 43.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D7 | 17.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D14 | 10.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D0 | 37.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D7 | 45.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D14 | 56.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D30 | 35.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D180 | 17.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D0 | 1050.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D7 | 1587.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D14 | 2652.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D30 | 2635.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D180 | 1088.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D0 | 51.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D7 | 158.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D14 | 107.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D30 | 46.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D180 | 123.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+IFN+, D7 | 86.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40+TNF+IFN+, D14 | 82.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+IFN+, D30 | 43.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+IFN+, D180 | 16.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D7 | 21.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D14 | 17.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D180 | 25.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D0 | 107.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D7 | 348.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D14 | 457.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D30 | 284.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D180 | 134.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D14 | 601.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D0 | 34.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D0 | 45.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D7 | 86.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D14 | 49.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D7 | 254.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D30 | 82.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D0 | 138.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+, D180 | 87.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D14 | 157.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D7 | 30.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D7 | 12.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D30 | 139.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D180 | 244.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+IFN+, D180 | 104.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+IFN+, D180 | 17.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D14 | 17.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D0 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+IFN+, D0 | 8.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D7 | 72.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D7 | 512.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D14 | 64.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+IFN+, D7 | 111.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D30 | 86.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D30 | 27.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+IFN+, D180 | 59.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40+TNF+IFN+, D14 | 85.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D0 | 972.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+IFN+, D30 | 384.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D7 | 3392.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+IFN+, D30 | 44.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D14 | 3279.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+TNF+IFN+, D180 | 30.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D30 | 2593.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+IFN+, D180 | 22.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+TNF+, D180 | 1288.50 T cells/million cells |
Secondary
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D180 | 82.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D30 | 24.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D0 | 54.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D180 | 120.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D0 | 192.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D0 | 659.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D30 | 584.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D7 | 2048.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D7 | 844.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D14 | 1724.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D7 | 201.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D30 | 1042.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D14 | 388.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D180 | 1184.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D14 | 1106.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D0 | 74.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D30 | 194.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D7 | 491.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D14 | 130.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D14 | 554.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D180 | 191.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D30 | 382.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D180 | 543.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D180 | 109.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D0 | 43.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D30 | 75.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D7 | 123.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D7 | 141.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D14 | 68.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D7 | 2050.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D30 | 24.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D14 | 30.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D180 | 17.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D0 | 562.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D180 | 30.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D0 | 270.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D7 | 2296.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D14 | 1108.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D30 | 697.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+, D180 | 507.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D0 | 138.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D7 | 165.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D14 | 92.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D30 | 134.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IL2+, D180 | 93.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D0 | 129.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D7 | 635.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D14 | 477.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D30 | 608.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, TNF+, D180 | 40.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D0 | 42.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D7 | 93.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D14 | 71.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D30 | 30.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, IFN+, D180 | 36.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D0 | 761.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D7 | 2496.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D14 | 1860.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D30 | 1217.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IL2+, D180 | 1309.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D0 | 95.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D7 | 591.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D14 | 596.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D30 | 234.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+TNF+, D180 | 63.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D0 | 9.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D7 | 127.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D14 | 60.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | F4co_est, CD40L+IFN+, D30 | 61.00 T cells/million cells |
Secondary
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D180 | 85.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D30 | 52.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D0 | 77.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D180 | 30.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D0 | 112.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D30 | 347.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D7 | 57.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D7 | 129.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D14 | 55.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D14 | 375.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D14 | 122.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D180 | 278.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D0 | 60.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D30 | 22.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D7 | 36.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D7 | 359.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D14 | 56.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D0 | 608.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D0 | 301.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D7 | 532.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D14 | 201.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D30 | 242.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+, D180 | 150.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D0 | 64.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D7 | 84.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D14 | 141.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D30 | 73.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+, D180 | 127.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D0 | 9.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D7 | 176.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D30 | 67.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+, D180 | 14.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D0 | 58.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D7 | 29.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D14 | 21.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D30 | 22.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IFN+, D180 | 23.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D7 | 5.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IFN+, D30 | 4.00 T cells/million cells |
Secondary
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D7 | 15.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40+TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D0 | 28.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+IFN+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D7 | 23.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D30 | 27.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, TNF+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40+TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+IFN+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D14 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, IL2+TNF+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D30 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+TNF+IFN+, D180 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | F4co_est, CD40L+IL2+TNF+, D180 | 4.00 T cells/million cells |
Secondary
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D7 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D14 | 28.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D0 | 9.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D7 | 5.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D14 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D0 | 97.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D7 | 268.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D14 | 480.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D30 | 401.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D180 | 118.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D7 | 33.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D14 | 8.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D30 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+IFN+, D7 | 12.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40+TNF+IFN+, D14 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D0 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D7 | 67.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D14 | 29.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D30 | 41.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D180 | 26.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D14 | 28.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D7 | 6.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D14 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D7 | 15.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D0 | 12.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D14 | 10.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D30 | 25.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D180 | 24.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+IFN+, D180 | 10.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D7 | 6.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D7 | 80.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D30 | 6.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+IFN+, D180 | 7.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40+TNF+IFN+, D14 | 10.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D0 | 93.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+IFN+, D30 | 38.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D7 | 333.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D14 | 292.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D30 | 191.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+TNF+, D180 | 107.00 T cells/million cells |
Secondary
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D180 | 21.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D0 | 84.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D30 | 193.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D7 | 199.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D7 | 115.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D14 | 258.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D7 | 29.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D30 | 97.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D14 | 28.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D180 | 148.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D14 | 224.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D0 | 3.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D7 | 102.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D14 | 25.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D14 | 95.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D30 | 56.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D180 | 107.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D180 | 13.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D7 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D14 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D7 | 339.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D14 | 20.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D0 | 113.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D7 | 294.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D14 | 219.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D30 | 153.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+, D180 | 54.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D0 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D14 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D30 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IL2+, D180 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D7 | 97.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D14 | 95.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D30 | 10.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, IFN+, D180 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D0 | 57.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D7 | 263.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D14 | 191.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D30 | 139.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IL2+, D180 | 129.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D0 | 6.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D7 | 55.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D14 | 56.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D30 | 27.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D7 | 15.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Nef, CD40L+IFN+, D30 | 13.00 T cells/million cells |
Secondary
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D30 | 2.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D30 | 191.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D7 | 22.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D14 | 122.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D14 | 40.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D180 | 134.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D7 | 90.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D0 | 155.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D0 | 72.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D7 | 173.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D14 | 10.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D30 | 30.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+, D180 | 43.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D0 | 9.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D14 | 59.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IL2+, D180 | 26.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D7 | 4.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Nef, CD40L+IFN+, D30 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D0 | 27.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D30 | 150.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D7 | 196.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D7 | 40.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D14 | 112.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D7 | 28.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D30 | 122.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D14 | 67.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D180 | 138.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D14 | 112.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D0 | 24.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D30 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D7 | 41.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D14 | 8.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D14 | 28.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D30 | 41.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D180 | 28.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D7 | 7.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D14 | 8.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D7 | 237.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D30 | 10.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D0 | 23.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D7 | 217.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D14 | 132.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D30 | 82.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+, D180 | 78.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D7 | 5.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D30 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D7 | 68.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D14 | 140.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D30 | 82.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+, D180 | 20.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D14 | 9.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D0 | 69.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D7 | 165.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D14 | 139.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D30 | 110.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+, D180 | 193.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D7 | 61.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D14 | 41.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D30 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IFN+, D30 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D14 | 10.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D180 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D7 | 7.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D0 | 84.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D7 | 194.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D14 | 192.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D30 | 204.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D180 | 94.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D7 | 27.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D30 | 10.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D180 | 13.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+IFN+, D7 | 5.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D7 | 34.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D14 | 23.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D30 | 40.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D180 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D14 | 42.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D30 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D180 | 17.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+IFN+, D180 | 13.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D7 | 31.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40+TNF+IFN+, D14 | 11.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D0 | 115.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+IFN+, D30 | 55.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D7 | 302.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D14 | 314.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D30 | 203.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P17, CD40L+IL2+TNF+, D180 | 239.50 T cells/million cells |
Secondary
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | p17, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | p17, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D180 | 3.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D0 | 65.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D7 | 40.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D30 | 7.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D180 | 44.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D7 | 7.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D14 | 25.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D180 | 10.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D7 | 34.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D30 | 13.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, CD40L+, D180 | 4.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D7 | 21.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D14 | 33.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, IL2+, D180 | 39.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D7 | 21.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P17, TNF+, D14 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D7 | 16.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D14 | 27.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D7 | 7.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D0 | 267.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D7 | 389.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D14 | 569.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D30 | 516.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D180 | 233.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D7 | 20.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D14 | 11.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D180 | 18.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+IFN+, D7 | 12.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40+TNF+IFN+, D14 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D7 | 140.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D14 | 66.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D30 | 40.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D180 | 43.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D180 | 229.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D180 | 22.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D0 | 9.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D7 | 9.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D14 | 22.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D30 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+, D180 | 27.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D14 | 23.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D30 | 57.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D30 | 15.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+IFN+, D180 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D0 | 14.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D7 | 12.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D30 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D14 | 81.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D0 | 135.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40+TNF+IFN+, D14 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D7 | 410.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D14 | 456.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+, D30 | 379.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+TNF+IFN+, D7 | 70.00 T cells/million cells |
Secondary
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D180 | 35.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D0 | 176.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D30 | 86.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D7 | 275.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D7 | 69.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D14 | 244.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D7 | 40.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D30 | 83.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D14 | 36.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D180 | 234.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D14 | 217.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D0 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D7 | 104.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D14 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D14 | 86.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D180 | 35.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D30 | 54.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D180 | 118.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D30 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D7 | 12.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D7 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D14 | 11.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D7 | 452.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D0 | 79.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D0 | 70.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D7 | 395.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D14 | 154.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D30 | 181.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+, D180 | 165.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D0 | 13.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D7 | 24.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D14 | 5.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D30 | 41.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IL2+, D180 | 2.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D0 | 6.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D7 | 73.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D14 | 53.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D30 | 8.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D14 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D0 | 137.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D7 | 230.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D14 | 284.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D30 | 189.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IL2+, D180 | 196.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D0 | 21.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D7 | 99.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D14 | 125.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D30 | 42.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+TNF+, D180 | 14.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D14 | 9.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | P24, CD40L+IFN+, D30 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D30 | 25.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D7 | 7.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D14 | 100.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D180 | 16.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D0 | 5.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D7 | 61.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D0 | 178.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D0 | 103.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D7 | 37.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D14 | 30.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D30 | 59.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D30 | 32.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D7 | 27.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | P24, CD40L+IFN+, D30 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D7 | 160.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D14 | 122.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D30 | 25.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D180 | 26.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D7 | 6.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D0 | 55.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D7 | 38.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D14 | 51.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D30 | 27.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D180 | 19.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D0 | 792.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D7 | 1430.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D14 | 2032.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D30 | 2243.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D180 | 1146.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D0 | 28.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D7 | 140.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D14 | 96.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D30 | 24.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D180 | 116.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+TNF+IFN+, D7 | 70.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40+TNF+IFN+, D14 | 74.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+TNF+IFN+, D30 | 55.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+TNF+IFN+, D180 | 27.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D7 | 18.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D14 | 8.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D180 | 13.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D0 | 95.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D7 | 285.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D14 | 337.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D30 | 244.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D180 | 163.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D14 | 639.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D0 | 56.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D0 | 30.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D7 | 93.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D0 | 11.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D14 | 83.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D7 | 204.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D30 | 109.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D0 | 147.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+, D180 | 59.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D14 | 151.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D30 | 109.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D180 | 216.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D30 | 11.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+IFN+, D180 | 60.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+IFN+, D180 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D14 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D7 | 56.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D7 | 484.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D14 | 83.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+TNF+IFN+, D7 | 97.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D30 | 75.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D30 | 17.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, TNF+IFN+, D180 | 28.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40+TNF+IFN+, D14 | 85.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D0 | 836.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+IFN+, D30 | 413.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D7 | 2764.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+TNF+IFN+, D30 | 82.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D14 | 2804.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, IL2+TNF+IFN+, D180 | 17.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D30 | 2137.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+TNF+IFN+, D180 | 27.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines | Pool_F4co, CD40L+IL2+TNF+, D180 | 1246.00 T cells/million cells |
Secondary
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co\_est).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D14 | 1015.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D30 | 653.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D180 | 497.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D0 | 41.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D7 | 141.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D14 | 100.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D30 | 55.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D180 | 32.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D0 | 20.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D7 | 547.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D14 | 612.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D30 | 225.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D180 | 126.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D0 | 7.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D7 | 110.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D14 | 32.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D30 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D180 | 35.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D0 | 469.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D7 | 1542.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D14 | 1423.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D30 | 964.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D180 | 961.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D0 | 102.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D7 | 514.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D14 | 706.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D30 | 399.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D180 | 81.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D7 | 82.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D14 | 59.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D30 | 21.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D0 | 177.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D7 | 1809.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D30 | 41.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D0 | 568.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D30 | 650.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D180 | 74.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D180 | 429.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D7 | 2199.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D0 | 57.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D14 | 1175.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D7 | 81.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D14 | 2037.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D14 | 92.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D30 | 97.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D30 | 1277.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IL2+, D180 | 58.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D180 | 27.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D0 | 242.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IL2+, D180 | 1351.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D7 | 625.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D7 | 112.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D14 | 610.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D0 | 69.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D30 | 445.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D7 | 2215.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, TNF+, D180 | 56.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D7 | 575.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+IFN+, D14 | 56.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D7 | 98.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D14 | 498.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D14 | 47.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+, D0 | 264.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D30 | 38.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, CD40L+TNF+, D30 | 291.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | Pool_F4co, IFN+, D180 | 38.50 T cells/million cells |
Secondary
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D180 [ | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+TNF+IFN+, D180 [ | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est).
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D180 | 27.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D0 ] | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D30 | 84.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D7 | 26.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D14 | 2.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D14 | 113.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D14 | 31.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D180 | 61.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D7 | 141.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D14 | 5.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D0 | 114.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D0 | 105.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D7 | 185.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D30 | 69.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+, D180 | 48.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D0 | 22.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D7 | 3.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D14 | 32.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D30 | 20.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D0 ] | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D7 | 5.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D0 | 28.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D30 | 17.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | Pool_F4co, CD40L+IFN+, D30 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D180 | 41.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D180 | 13.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D0 | 18.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D0 | 377.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D30 | 262.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D7 | 924.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D7 | 421.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D14 | 922.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D7 | 85.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D30 | 615.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D14 | 228.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D180 | 558.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D14 | 522.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D0 | 41.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D30 | 124.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D7 | 237.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D14 | 97.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D14 | 300.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D180 | 74.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D30 | 204.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D180 | 229.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D180 | 54.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D0 | 7.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D30 | 24.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D7 | 69.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D7 | 91.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D14 | 27.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D7 | 1080.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D30 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D14 | 9.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D0 | 163.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D180 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D0 | 184.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D7 | 1209.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D14 | 748.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D30 | 309.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+, D180 | 249.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D0 | 15.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D7 | 42.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D14 | 35.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D30 | 36.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+, D180 | 74.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D0 | 61.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D7 | 312.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D14 | 318.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D30 | 231.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+, D180 | 7.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D0 | 13.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D7 | 56.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D14 | 16.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IFN+, D180 | 12.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D0 | 315.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D7 | 1424.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D14 | 990.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D30 | 828.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+, D180 | 797.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D0 | 36.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D7 | 315.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D14 | 291.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D30 | 137.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+, D180 | 40.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D7 | 84.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D14 | 28.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IFN+, D30 | 15.00 T cells/million cells |
Secondary
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D7 | 83.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D14 | 53.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D30 | 27.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D180 | 26.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D7 | 10.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D0 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D7 | 18.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D14 | 23.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D30 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D0 | 475.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D7 | 842.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D14 | 1606.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D30 | 1209.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D180 | 471.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D0 | 15.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D7 | 89.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D14 | 54.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D30 | 30.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D180 | 68.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+IFN+, D7 | 43.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40+TNF+IFN+, D14 | 50.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+IFN+, D30 | 27.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D7 | 13.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D14 | 8.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D0 | 57.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D7 | 206.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D14 | 254.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D30 | 136.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D180 | 64.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D14 | 285.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D0 | 6.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D0 | 12.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D7 | 37.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D14 | 22.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D7 | 151.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D30 | 55.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D0 | 48.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+, D180 | 67.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D14 | 84.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D7 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D30 | 56.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D180 | 87.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+IFN+, D180 | 40.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D7 | 28.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D7 | 213.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D14 | 14.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+IFN+, D7 | 56.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D30 | 19.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D30 | 13.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, TNF+IFN+, D180 | 15.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40+TNF+IFN+, D14 | 28.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D0 | 474.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+IFN+, D30 | 237.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D7 | 1575.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+IFN+, D30 | 15.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D14 | 1901.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, IL2+TNF+IFN+, D180 | 13.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D30 | 1297.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines | RT, CD40L+IL2+TNF+, D180 | 709.50 T cells/million cells |
Secondary
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D30 | 4.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D0 | 31.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D30 | 113.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D7 | 32.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D14 | 91.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D14 | 64.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D180, | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D30 | 3.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D7 | 121.50 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D14 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D0 | 146.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D0 | 123.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D7 | 168.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D30 | 27.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+, D180 | 52.50 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D14 | 32.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D7 | 34.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+, D180, | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IFN+, D30 | 1.00 T cells/million cells |
Secondary
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461+Nivaquine Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+IFN+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+IFN+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40+TNF+IFN+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D0 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D7 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+IFN+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D14 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, IL2+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D30 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+TNF+IFN+, D180 | 1.00 T cells/million cells |
| GSK732461 Group | Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine | RT, CD40L+IL2+TNF+, D180 | 1.00 T cells/million cells |
Secondary
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 0 | 477.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 14 | 890.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 7 | 872.50 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 0 | 846.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 14 | 1198.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 30 | 627.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 30 | 641.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 180 | 1205.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 180 | 530.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 180 | 305.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 0 | 1421.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 14 | 3162.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 7 | 3881.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 0 | 154.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 14 | 4898.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 0 | 259.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 30 | 3791.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 7 | 464.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 180 | 2238.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 7 | 2407.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 0 | 2000.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 14 | 453.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 7 | 4390.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 30 | 397.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 14 | 5272.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 7 | 586.50 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 30 | 4407.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 180 | 278.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 180 | 2530.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 30 | 2088.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 180 | 3079.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 0 | 1125.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 7 | 3286.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 14 | 3461.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 30 | 2459.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | RT, Day 180 | 1684.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 0 | 161.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 7 | 739.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 14 | 560.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 30 | 386.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Nef, Day 180 | 306.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 0 | 176.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 7 | 500.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 30 | 346.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 180 | 523.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 0 | 434.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 7 | 911.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 14 | 827.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 30 | 793.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P24, Day 180 | 536.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 0 | 2006.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 7 | 5515.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 14 | 5651.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 30 | 4138.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | Pool_F4co, Day 180 | 2856.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 0 | 1974.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 7 | 6613.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 14 | 6035.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | F4co_est, Day 30 | 4589.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines | P17, Day 14 | 503.00 T cells/million cells |
Secondary
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool\_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co\_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D0 | 68.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D30 | 61.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D7 | 93.50 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D7 | 127.50 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D14 | 83.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D180 | 39.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D30 | 120.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D0 | 75.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D180 | 62.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D0 | 104.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D0 | 76.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D30 | 57.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D7 | 218.50 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D7 | 109.50 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D14 | 92.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D7 | 63.50 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D30 | 68.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D14 | 124.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D180 | 65.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D14 | 94.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D0 | 373.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D30 | 18.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D7 | 448.50 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D14 | 123.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D14 | 478.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D180 | 55.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D30 | 290.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D180 | 14.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D180 | 226.00 T cells/million cells |
| GSK732461+Nivaquine Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D0 | 79.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D180 | 287.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D0 | 89.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D7 | 137.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D14 | 102.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D30 | 85.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | RT, D180 | 48.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D0 | 71.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D7 | 84.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D14 | 99.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D30 | 116.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Nef, D180 | 66.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D0 | 76.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D7 | 88.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D14 | 84.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D30 | 98.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P17, D180 | 80.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D0 | 77.50 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D7 | 54.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D14 | 91.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D30 | 81.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | P24, D180 | 45.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D0 | 148.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D7 | 129.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D14 | 118.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D30 | 122.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | Pool_F4co, D180 | 74.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D0 | 398.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D7 | 451.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D14 | 450.00 T cells/million cells |
| GSK732461 Group | Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine | F4co_est, D30 | 380.00 T cells/million cells |
Secondary
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS.
Time frame: At Day 0, 7, 14, 30 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 0 | 12 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 7 | 12 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 14 | 12 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 30 | 8 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 180 | 13 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 0 | 10 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 7 | 11 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 14 | 12 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 30 | 7 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 180 | 11 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 0 | 6 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 7 | 10 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 14 | 10 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 30 | 7 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 180 | 10 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 0 | 1 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 7 | 6 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 14 | 6 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 30 | 7 Participants |
| GSK732461+Nivaquine Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 180 | 3 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 14 | 8 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 0 | 11 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 0 | 4 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 7 | 12 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 0 | 3 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 14 | 12 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 7 | 10 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 30 | 13 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 180 | 4 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 1 antigen, Day 180 | 14 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 14 | 10 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 0 | 11 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 7 | 8 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 7 | 11 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 30 | 10 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 14 | 11 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 4 antigens, Day 30 | 6 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 30 | 13 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 3 antigens, Day 180 | 9 Participants |
| GSK732461 Group | Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens | 2 antigens, Day 180 | 13 Participants |