Malaria
Conditions
Keywords
safety, Vaccine, Phase 1/2, immunogenicity, Malaria, efficacy, sporozoite challenge
Brief summary
This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate the safety and the immune response to the new combination of the two experimental malaria vaccines.
Detailed description
Approximately 168 healthy, malaria-naïve volunteers aged 18 - 50 years, divided into 2 groups (84 in each group), will receive either one dose of Ad35.CS.01 followed by two doses of 257049 at monthly intervals or 3 doses of 257049 vaccine at monthly intervals. Of these, a maximum of 138 vaccinated volunteers will be challenged with P. falciparum infected mosquitoes. The challenge will occur 2 weeks following the third immunization. A group of up to 18 infectivity controls will begin participation in the study at the challenge stage. These controls receive no vaccine and are enrolled for malaria-challenge only in order to provide comparison group for vaccinated individuals.
Interventions
BIOLOGICALCrucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01)
One dose will be administered intramuscularly at Study Day 0.
BIOLOGICALGSK Biologicals' malaria vaccine 257049 (2 doses)
Two doses will be administered intramuscularly at monthly intervals
BIOLOGICALGSK Biologicals' malaria vaccine 257049 (3 doses)
Three doses will be administered intramuscularly at monthly intervals
OTHERSporozoite challenge
Subjects were challenged with sporozoite-infected mosquitoes to determine whether immune protective response had been induced by vaccination.
Sponsors
The PATH Malaria Vaccine Initiative (MVI)
Crucell Holland BV
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or non-pregnant female 18 to 50 years of age at the time of first vaccination. * Written informed consent obtained from the subject before screening procedures. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Available to participate for the duration of the study. * Female subjects of non-childbearing potential. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate Food and Drug Administration (FDA)-approved contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate FDA-approved contraception during the entire treatment period and for 2 months after completion of the vaccination series and/or malaria challenge. * Pass a comprehension assessment test.
Exclusion criteria
* Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use of any investigational or non-registered product other than the study vaccines during the study period. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 7 days of the first dose of vaccines. * Prior receipt of an investigational malaria or adenovirus vaccine. * Chronic use of antibiotics with antimalarial effects. * History of malaria chemoprophylaxis within 60 days prior to vaccination. * Any history of malaria. * Planned travel to malaria endemic areas during the study period. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) including latex. * History of allergic disease or reactions likely to be exacerbated by chloroquine. * History of psoriasis and porphyria, which may be exacerbated after chloroquine treatment. * Current use of medications known to cause drug reactions to chloroquine, such as antacids and kaolin. * Any history of anaphylaxis in reaction to any previous vaccination. * History of severe reactions to mosquito bites. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to first vaccine dose. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including immunodeficiency virus (HIV) infection. * Family history of congenital or hereditary immunodeficiency. * History of splenectomy. * Major congenital defects or serious chronic illness. * History of any neurological disorders or seizures. * Acute disease and/or fever at the time of enrollment. * Acute disease is defined as the presence of a moderate or severe illness with or without fever. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Any abnormal baseline laboratory screening tests. * Evidence of increased cardiovascular disease risk, moderate or high, according to the NHANES I criteria. * An abnormal baseline screening electrocardiogram (EKG). * Hepatomegaly, right upper quadrant abdominal pain or tenderness. * Personal history of autoimmune disease. * Seropositive for hepatitis B surface antigen or Hepatitis C virus (antibodies to HCV). * Pregnant or lactating female. * Female who intends to become pregnant during the study or planning to discontinue contraceptive measures. * Suspected or known current alcohol abuse. * Chronic or active intravenous drug use. * History of blood donation within 56 days preceding enrolment. * Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge | 28 days following sporozoite challenge (Day 105) | P. falciparum parasitemia was defined as a positive blood slide. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination | Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors \[uncontrollable shivering more than (\>) 15 seconds\]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination | 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 outside 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the study period (Day 0 - Day 236) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) | CS-specific CD8+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMC). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. |
| Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge | From day of challenge (Day 0) up to 159 days post-challenge | The onset of P. falciparum parasitemia was defined by a positive blood slide. |
| Frequency of CS-specific T-cells Producing IFN-γ | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) | The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) full length assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. |
| Frequency of HBs-specific CD4+ T-cells | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) | HB-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. |
| Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) | Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. |
| Anti-hepatitis B (Anti-HBs) Antibody Titers | 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) | Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. |
| Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) | Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. |
| Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) | CS-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs).Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ad35.CS.01 Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. | 28 |
| GSK257049 Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. | 27 |
| Control Group Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. | 12 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Declined challenged | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Migrated | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Ad35.CS.01 Group | GSK257049 Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 29.9 Years STANDARD_DEVIATION 7.03 | 30.3 Years STANDARD_DEVIATION 7.83 | 29.8 Years STANDARD_DEVIATION 6.86 | 30.04 Years STANDARD_DEVIATION 7.23 |
| Race/Ethnicity, Customized Races African heritage/African American | 9 Participants | 16 Participants | 5 Participants | 30 Participants |
| Race/Ethnicity, Customized Races American Indian or Alaskan native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Races Asian - Central/South Asian heritage | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Races Mixed Origin | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Races White - Caucasian/European heritage | 15 Participants | 9 Participants | 5 Participants | 29 Participants |
| Sex: Female, Male Female | 16 Participants | 10 Participants | 6 Participants | 32 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 6 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 27 | 0 / 12 |
| other Total, other adverse events | 27 / 28 | 27 / 27 | 12 / 12 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 | 0 / 12 |
Outcome results
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination
Population: The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 8 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 2 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 15 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 6 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 11 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 13 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 26 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 25 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 10 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 7 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 20 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 27 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 7 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 15 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 8 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 26 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 1 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 11 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 1 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 11 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 25 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 4 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 20 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors \[uncontrollable shivering more than (\>) 15 seconds\]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination
Population: The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Chills, Dose 3 | 2 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 3 | 8 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 8 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 3 | 3 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 3 | 14 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 14 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 3 | 2 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 3 | 2 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 3 | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Chills, Across doses | 15 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Chills, Across doses | 15 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Chills, Across doses | 4 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 15 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 15 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 5 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Across doses | 5 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Across doses | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 21 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 21 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 6 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 5 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Chills, Dose 1 | 7 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Chills, Dose 1 | 2 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 9 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 9 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 3 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 3 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 12 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 11 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 3 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Chills, Dose 2 | 6 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Chills, Dose 2 | 6 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Chills, Dose 2 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 9 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 8 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 10 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 9 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Chills, Dose 3 | 8 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Chills, Dose 3 | 8 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 1 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 3 | 3 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 3 | 0 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 2 Participants |
| Ad35.CS.01 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Chills, Dose 1 | 7 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 2 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Chills, Dose 3 | 7 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 2 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 3 | 10 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 4 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 9 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 3 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 3 | 2 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Dose 1 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 3 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Dose 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Chills, Dose 3 | 7 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 3 | 5 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 10 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 3 | 4 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 12 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 7 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Chills, Across doses | 13 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 2 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Chills, Across doses | 13 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 2 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Chills, Across doses | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 11 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 17 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 14 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Chills, Dose 3 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Chills, Dose 2 | 11 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 6 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms, Across doses | 5 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Chills, Dose 2 | 11 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms, Across doses | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 14 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Chills, Dose 2 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 13 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 11 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 9 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 8 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 11 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 8 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Chills, Dose 1 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Chills, Dose 1 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Chills, Dose 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 11 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 1 Participants |
Primary
Number of Subjects With Any 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 outside 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.
Time frame: Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination
Population: The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ad35.CS.01 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 23 Participants |
| GSK257049 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 21 Participants |
Primary
Number of Subjects With Any 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 outside 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.
Time frame: Within the 30-day (Day 0 - Day 29) follow-up period post-challenge
Population: The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ad35.CS.01 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 22 Participants |
| GSK257049 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 18 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 12 Participants |
Primary
Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge
P. falciparum parasitemia was defined as a positive blood slide.
Time frame: 28 days following sporozoite challenge (Day 105)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ad35.CS.01 Group | Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge | 14 Participants |
| GSK257049 Group | Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge | 10 Participants |
| Control Group | Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge | 12 Participants |
Comparison: Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at one month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.p-value: 0.767595% CI: [-107.4, 33.3]2-sided Fisher Exact test
Comparison: Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.p-value: 0.006695% CI: [20.7, 60.4]2-sided Fisher Exact test
Comparison: Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.p-value: 0.002195% CI: [25.4, 69.6]2-sided Fisher Exact test
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: Throughout the study period (Day 0 - Day 236)
Population: The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ad35.CS.01 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK257049 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points
Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.
Time frame: 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Ad35.CS.01 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D236 | 21.3 Titers |
| Ad35.CS.01 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D105 | 22.1 Titers |
| Ad35.CS.01 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D56 | 25.5 Titers |
| Ad35.CS.01 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D140 | 20.8 Titers |
| Ad35.CS.01 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D28 | 27.3 Titers |
| Ad35.CS.01 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D77 | 26.3 Titers |
| GSK257049 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D77 | 17.0 Titers |
| GSK257049 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D28 | 16.3 Titers |
| GSK257049 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D56 | 16.5 Titers |
| GSK257049 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D105 | 17.2 Titers |
| GSK257049 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D140 | 16.0 Titers |
| GSK257049 Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D236 | 16.5 Titers |
| Control Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D140 | 23.4 Titers |
| Control Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D77 | 23.2 Titers |
| Control Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D105 | 25.9 Titers |
| Control Group | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | D236 | 24.2 Titers |
Secondary
Anti-circumsporozoite Protein (Anti-CS) Antibody Titers
Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.
Time frame: 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Ad35.CS.01 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D236 | 21.4 Titers |
| Ad35.CS.01 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D105 | 50.0 Titers |
| Ad35.CS.01 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D28 | 0.9 Titers |
| Ad35.CS.01 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D140 | 40.5 Titers |
| Ad35.CS.01 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D77 | 55.5 Titers |
| Ad35.CS.01 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D56 | 14.3 Titers |
| GSK257049 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D105 | 96.6 Titers |
| GSK257049 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D28 | 14.7 Titers |
| GSK257049 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D56 | 79.2 Titers |
| GSK257049 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D77 | 115.9 Titers |
| GSK257049 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D140 | 62.3 Titers |
| GSK257049 Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D236 | 29.2 Titers |
| Control Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D140 | 0.4 Titers |
| Control Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D77 | 0.3 Titers |
| Control Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D105 | 0.5 Titers |
| Control Group | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | D236 | 0.3 Titers |
Secondary
Anti-hepatitis B (Anti-HBs) Antibody Titers
Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.
Time frame: 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Ad35.CS.01 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D236 | 15589.7 Titers |
| Ad35.CS.01 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D105 | 28180.7 Titers |
| Ad35.CS.01 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D28 | 53.0 Titers |
| Ad35.CS.01 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D140 | 29307.7 Titers |
| Ad35.CS.01 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D77 | 30877.5 Titers |
| Ad35.CS.01 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D56 | 15845.4 Titers |
| GSK257049 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D105 | 77659.2 Titers |
| GSK257049 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D28 | 26596.6 Titers |
| GSK257049 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D56 | 59388.2 Titers |
| GSK257049 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D77 | 103746.8 Titers |
| GSK257049 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D140 | 47932.8 Titers |
| GSK257049 Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D236 | 40727.8 Titers |
| Control Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D140 | 41.2 Titers |
| Control Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D77 | 35.6 Titers |
| Control Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D105 | 47.4 Titers |
| Control Group | Anti-hepatitis B (Anti-HBs) Antibody Titers | D236 | 34.2 Titers |
Secondary
Frequency of CS-specific T-cells Producing IFN-γ
The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) full length assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.
Time frame: 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad35.CS.01 Group | Frequency of CS-specific T-cells Producing IFN-γ | D236 | 167.91 spots/million PBMCs | Standard Deviation 153.79 |
| Ad35.CS.01 Group | Frequency of CS-specific T-cells Producing IFN-γ | D105 | 232.35 spots/million PBMCs | Standard Deviation 175.77 |
| Ad35.CS.01 Group | Frequency of CS-specific T-cells Producing IFN-γ | D42 | 297.97 spots/million PBMCs | Standard Deviation 243.24 |
| Ad35.CS.01 Group | Frequency of CS-specific T-cells Producing IFN-γ | D140 | 208.97 spots/million PBMCs | Standard Deviation 125.45 |
| Ad35.CS.01 Group | Frequency of CS-specific T-cells Producing IFN-γ | D77 | 225.98 spots/million PBMCs | Standard Deviation 161.51 |
| Ad35.CS.01 Group | Frequency of CS-specific T-cells Producing IFN-γ | D14 | 51.05 spots/million PBMCs | Standard Deviation 61.89 |
| GSK257049 Group | Frequency of CS-specific T-cells Producing IFN-γ | D14 | 63.20 spots/million PBMCs | Standard Deviation 100.85 |
| GSK257049 Group | Frequency of CS-specific T-cells Producing IFN-γ | D42 | 54.27 spots/million PBMCs | Standard Deviation 53.52 |
| GSK257049 Group | Frequency of CS-specific T-cells Producing IFN-γ | D77 | 64.54 spots/million PBMCs | Standard Deviation 87.4 |
| GSK257049 Group | Frequency of CS-specific T-cells Producing IFN-γ | D105 | 58.04 spots/million PBMCs | Standard Deviation 76.86 |
| GSK257049 Group | Frequency of CS-specific T-cells Producing IFN-γ | D140 | 50.77 spots/million PBMCs | Standard Deviation 71.69 |
| GSK257049 Group | Frequency of CS-specific T-cells Producing IFN-γ | D236 | 38.85 spots/million PBMCs | Standard Deviation 56.36 |
| Control Group | Frequency of CS-specific T-cells Producing IFN-γ | D140 | 75.74 spots/million PBMCs | Standard Deviation 135.72 |
| Control Group | Frequency of CS-specific T-cells Producing IFN-γ | D77 | 66.68 spots/million PBMCs | Standard Deviation 124.31 |
| Control Group | Frequency of CS-specific T-cells Producing IFN-γ | D105 | 90.75 spots/million PBMCs | Standard Deviation 219.5 |
| Control Group | Frequency of CS-specific T-cells Producing IFN-γ | D236 | 105.12 spots/million PBMCs | Standard Deviation 255.2 |
Secondary
Frequency of CS-specific T-cells Producing IFN-γ
The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) N-terminal assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs).
Time frame: 14 days post-dose 1 (Day 14)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ad35.CS.01 Group | Frequency of CS-specific T-cells Producing IFN-γ | 18.88 spots/million PBMCs | Standard Deviation 19.97 |
| GSK257049 Group | Frequency of CS-specific T-cells Producing IFN-γ | 14.57 spots/million PBMCs | Standard Deviation 18.39 |
Secondary
Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells
CS-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs).Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.
Time frame: 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D42 | 1693.38 T-cells/million PBMCs | Standard Deviation 1268.5 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D140 | 893.68 T-cells/million PBMCs | Standard Deviation 933.95 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D236 | 750.95 T-cells/million PBMCs | Standard Deviation 676.98 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D14 | 143.23 T-cells/million PBMCs | Standard Deviation 170.19 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D77 | 1364.95 T-cells/million PBMCs | Standard Deviation 1025.92 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D105 | 1149.29 T-cells/million PBMCs | Standard Deviation 560.47 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D236 | 363.69 T-cells/million PBMCs | Standard Deviation 272.73 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D42 | 854.29 T-cells/million PBMCs | Standard Deviation 911.56 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D140 | 492.14 T-cells/million PBMCs | Standard Deviation 424.34 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D77 | 608.59 T-cells/million PBMCs | Standard Deviation 744.99 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D14 | 220.25 T-cells/million PBMCs | Standard Deviation 188.34 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D105 | 622.27 T-cells/million PBMCs | Standard Deviation 448.5 |
| Control Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D140 | 36.40 T-cells/million PBMCs | Standard Deviation 75.39 |
| Control Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D236 | 59.55 T-cells/million PBMCs | Standard Deviation 65.07 |
| Control Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D105 | 80.90 T-cells/million PBMCs | Standard Deviation 88.4 |
| Control Group | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | D77 | 96.00 T-cells/million PBMCs | Standard Deviation 94.72 |
Secondary
Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells
CS-specific CD8+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMC). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.
Time frame: 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D140 | 99.95 T-cells/million PBMCs | Standard Deviation 159.19 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D14 | 37.04 T-cells/million PBMCs | Standard Deviation 64.66 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D42 | 76.81 T-cells/million PBMCs | Standard Deviation 107.06 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D77 | 94.86 T-cells/million PBMCs | Standard Deviation 153.45 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D105 | 131.47 T-cells/million PBMCs | Standard Deviation 153.24 |
| Ad35.CS.01 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D236 | 42.74 T-cells/million PBMCs | Standard Deviation 47.54 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D140 | 26.18 T-cells/million PBMCs | Standard Deviation 34.99 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D14 | 18.29 T-cells/million PBMCs | Standard Deviation 33.1 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D105 | 32.27 T-cells/million PBMCs | Standard Deviation 40.73 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D42 | 25.29 T-cells/million PBMCs | Standard Deviation 37.31 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D77 | 31.35 T-cells/million PBMCs | Standard Deviation 34.89 |
| GSK257049 Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D236 | 28.00 T-cells/million PBMCs | Standard Deviation 51.66 |
| Control Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D77 | 19.00 T-cells/million PBMCs | Standard Deviation 32.21 |
| Control Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D105 | 8.50 T-cells/million PBMCs | Standard Deviation 16.43 |
| Control Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D236 | 48.45 T-cells/million PBMCs | Standard Deviation 68.98 |
| Control Group | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | D140 | 44.60 T-cells/million PBMCs | Standard Deviation 93.49 |
Secondary
Frequency of HBs-specific CD4+ T-cells
HB-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.
Time frame: 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad35.CS.01 Group | Frequency of HBs-specific CD4+ T-cells | D42 | 1518.36 T-cells/million PBMCs | Standard Deviation 1526.01 |
| Ad35.CS.01 Group | Frequency of HBs-specific CD4+ T-cells | D236 | 940.16 T-cells/million PBMCs | Standard Deviation 564.66 |
| Ad35.CS.01 Group | Frequency of HBs-specific CD4+ T-cells | D14 | 373.67 T-cells/million PBMCs | Standard Deviation 613.02 |
| Ad35.CS.01 Group | Frequency of HBs-specific CD4+ T-cells | D140 | 1158.47 T-cells/million PBMCs | Standard Deviation 804.4 |
| Ad35.CS.01 Group | Frequency of HBs-specific CD4+ T-cells | D105 | 1265.00 T-cells/million PBMCs | Standard Deviation 863.73 |
| Ad35.CS.01 Group | Frequency of HBs-specific CD4+ T-cells | D77 | 1163.77 T-cells/million PBMCs | Standard Deviation 1022.03 |
| GSK257049 Group | Frequency of HBs-specific CD4+ T-cells | D105 | 1310.53 T-cells/million PBMCs | Standard Deviation 747.79 |
| GSK257049 Group | Frequency of HBs-specific CD4+ T-cells | D14 | 1400.80 T-cells/million PBMCs | Standard Deviation 2449.05 |
| GSK257049 Group | Frequency of HBs-specific CD4+ T-cells | D42 | 1836.33 T-cells/million PBMCs | Standard Deviation 2264.88 |
| GSK257049 Group | Frequency of HBs-specific CD4+ T-cells | D77 | 1023.58 T-cells/million PBMCs | Standard Deviation 936.22 |
| GSK257049 Group | Frequency of HBs-specific CD4+ T-cells | D140 | 1181.00 T-cells/million PBMCs | Standard Deviation 603.43 |
| GSK257049 Group | Frequency of HBs-specific CD4+ T-cells | D236 | 1244.38 T-cells/million PBMCs | Standard Deviation 833.86 |
| Control Group | Frequency of HBs-specific CD4+ T-cells | D140 | 531.90 T-cells/million PBMCs | Standard Deviation 407.21 |
| Control Group | Frequency of HBs-specific CD4+ T-cells | D77 | 232.13 T-cells/million PBMCs | Standard Deviation 301.75 |
| Control Group | Frequency of HBs-specific CD4+ T-cells | D105 | 569.70 T-cells/million PBMCs | Standard Deviation 489.67 |
| Control Group | Frequency of HBs-specific CD4+ T-cells | D236 | 498.36 T-cells/million PBMCs | Standard Deviation 313.94 |
Secondary
Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge
The onset of P. falciparum parasitemia was defined by a positive blood slide.
Time frame: From day of challenge (Day 0) up to 159 days post-challenge
Population: The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ad35.CS.01 Group | Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge | 14 Days | Standard Deviation 1 |
| GSK257049 Group | Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge | 14 Days | Standard Deviation 2 |
| Control Group | Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge | 12 Days | Standard Deviation 2 |