Human Immunodeficiency Virus
Conditions
Brief summary
The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26 (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on suppressive antiretroviral therapy (ART) that was initiated during acute Human Immunodeficiency Virus (HIV) infection; 2) Measure the frequency and duration of sustained viremic control after receiving Ad26 prime/MVA boost or placebo, defined as greater than 24 weeks with plasma HIV ribonucleic acid (RNA) lesser than (\<)50 copies/ml after antiretroviral (ARV) analytical treatment interruption (ATI).
Interventions
BIOLOGICALAd26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
BIOLOGICALMVA-Mosaic
Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10\^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.
DRUGPlacebo
Participants will receive placebo intramuscularly Weeks 0, 12, 24 and 48.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed human immunodeficiency virus (HIV)-1 infected and started antiretroviral therapy (ART) during acute infection (Fiebig stages I, II, III or IV) as part of trial RV254 * Treatment with current stable antiretroviral therapy (ART) (no changes to treatment) for at least 4 weeks prior to screening * All female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) at the screening visit, and a negative urine pregnancy test prior to vaccination on Day 1 and prior to subsequent study vaccinations * HIV ribonucleic acid (RNA) less than (\<)50 copies per milliliter (copies/ml) for at least 48 weeks at screening: a) One blip of HIV RNA greater than (\>)50 and \<200 copies/ml within 48 weeks is acceptable, provided that the most recent (before screening) HIV RNA \<50 copies/ml * Laboratory criteria during screening: a) Hemoglobin: Women: greater than or equal to \>=11 gram/deciliter (g/dL); Men \>=12.5 g/dL, b) White cell count: 2,500 to 11,000 cells per cubic millimeter (cells/mm\^3), c) Platelets: 125,000 to 450,000 per mm\^3, d) Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to \<=1.5x institutional upper limits of normal (ULN), e) Creatinine \<=1.5x institutional ULN, f) CD4 \> 400 cells/mm\^3, g) Troponin \<1x ULN * A woman must be either: a) Not of childbearing potential: postmenopausal (\>45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulation hormone \[FSH\] level \>40 International Units Per Liter (IU/L); surgically sterile; or b) Of child-bearing potential and practicing an effective double method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, contraceptive patch, or vaginal ring, in conjunction with either a female condom or one of the methods for male contraception before entry and through 3 months after the last vaccination
Exclusion criteria
* Receipt of any vaccine within 30 days prior to the first vaccination or plans to receive within 30 days post-vaccination. In the case of medically indicated vaccines, the vaccination should be given at least 2 weeks before or after the first vaccination. However, if a vaccine is indicated in a post exposure setting (example, rabies or tetanus), it must take priority over the study vaccine and same rules will apply to subsequent study vaccinations * Any history of HIV-related illness under Centers for Disease Control and Prevention (CDC) category C * History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up) * Chronic active hepatitis B or active hepatitis C (for example, positive serology with confirmatory positive polymerase chain reaction) or active syphilis infection. Active syphilis documented by examination or serology unless positive serology is due to past treated infection * Receipt of blood products or immunoglobulin in the past 3 months * History of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, or neomycin or streptomycin or egg products * History of chronic urticaria (recurrent hives) * Chronic or recurrent use of medications which modify host immune response, example (e.g.) cancer chemotherapeutic agents, parenteral corticosteroids (short course oral steroids given for non-chronic conditions not expected to recur is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sustained Viremic Control With HIV RNA <50 Copies/mL During ATI Phase | From Week 60 to Week 96 | Duration of sustained viremic control With HIV RNA \<50 copies/mL during ATI Phase was reported. |
| Percentage of Participants With Grade 3 or 4 Solicited Systemic AEs | Up to Week 49 (7 days post each vaccination) | Solicited systemic AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching. |
| Percentage of Participants With Grade 3 or 4 Unsolicited AEs | Up to Week 52 (28 days after each vaccination) | Unsolicited AE with worst severity grade 3 or 4 and that is thought to be related to study vaccine were reported. Unsolicited AEs were defined as events that participants experienced but were not specifically asked about. |
| Percentage of Participants With Grade 3 or 4 Related AEs | Up to Week 52 (28 days after each vaccination) | Related AEs of grade 3 or 4 and that is thought to be related to study vaccine were reported. |
| Percentage of Participants With Solicited Local AEs for 7 Days After Each Vaccination | Up to Week 49 (7 days post each vaccination) | An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination. |
| Percentage of Participants With Solicited Systemic AEs for 7 Days After Each Vaccination | Up to Week 49 (7 days after each vaccination) | Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching were collected and reported for 7 days after each vaccination. |
| Percentage of Participants With Unsolicited AEs 28 Days After Each Vaccination | Up to Week 52 (28 days after each vaccination) | Unsolicited AEs were defined as events that participants experienced but were not specifically asked about. |
| Percentage of Participants With Related AEs and Serious Adverse Events (SAEs) | Up to Week 52 (28 days after each vaccination) | An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product. |
| Percentage of Participants With AEs Leading to Discontinuation of Study Vaccination | Up to Week 96 | Percentage of participants with AEs leading to discontinuation of study vaccination were reported. |
| Percentage of Participants With AEs | Up to Week 52 (28 days after each vaccination) | Percentage of participants with AEs were reported. |
| Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | Up to Week 96 | Percentage of participants with worst laboratory grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening) and non-graded serum chemistry abnormalities were reported. Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, creatine, hyperglycemia, hypoglycemia, gamma-gutamyl transferase, chloride, urea nitrogen, and bilirubin. The parameters not represented in the grading scale, abnormalities were indicated as being 'high' or 'low' or 'abnormal'. |
| Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Up to Week 96 | Percentage of participants with worst laboratory toxicity grade 1 (mild) and non-graded hematology abnormalities were reported. Hematology parameters included absolute neutrophil count, basophils/leukocytes, eosinophils/leukocytes, hematocrit, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, erythrocytes, hematocrit, neutrophils, basophils, eosinophils, eosinophils/leukocytes, monocytes, neutrophils and platelet count. The parameters not represented in the grading scale, abnormalities were indicated as being 'high' or 'low' or 'abnormal'. |
| Percentage of Participants With Sustained Viremic Control (Human Immunodeficiency Virus [HIV] Ribonucleic Acid [RNA] Less Than [<]50 Copies Per Milliliter [Copies/mL]) During ATI Phase | From Week 60 to Week 96 | Percentage of participants with sustained viremic control (HIV RNA \<50 copies/mL) during ATI phase were reported. |
| Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs) | Up to Week 49 (7 days post each vaccination) | Solicited local AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cluster of Differentiation (CD)4 Count Over Time | Baseline and from Week 60 to Week 96 | Change in CD4 count over time was reported. Assessment of residual HIV replication and viral reservoir in total CD4+ T cells was measured by quantitative real-time polymerase chain reaction (PCR). |
| Time to Reinitiating ART | Up to Week 96 | Time to reinitiating ART was reported. |
| Number of Participants With Acute Retroviral Syndrome Post-ARV ATI | From Week 60 to Week 96 | Number of participants with acute retroviral syndrome post-ARV ATI were reported. |
| Duration of Acute Retroviral Syndrome Post-ARV ATI | From Week 60 to Week 96 | Duration of acute retroviral syndrome post-ARV ATI was reported. |
| Percentage of Participants With HIV Resistance to ARV Drugs Who Experienced Rebound Viremia After ARV ATI | From Week 60 to Week 96 | Percentage of participants with HIV resistance to ARV drugs who experienced rebound viremia after ARV ATI were reported. An HIV genotype test was done to evaluate and characterize HIV resistance to ARV drugs in participants who experience rebound viremia after ARV ATI. |
| Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | At Week 24, 26, 48 and 50 | Frozen peripheral blood mononuclear cell (PBMCs) was analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value \>P95 if baseline \<P95 or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study. |
| Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | At Week 24, 26, 48 and 50 | The Env Clade A (92UG037), B (1990a), and C (Con C), (C97ZA.012) and Mos1- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline greater than or equal to (\>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, 156.25 and 78.125 endotoxin units per milliliter (EU/mL) for Clade A (92UG037), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012) and Mos1 respectively. |
| Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody | Week 50 | Vaccine-induced binding antibody IgG1, IgG2, and IgG3 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQs for this assay were 12.3, 28.7, and 12.4, for IgG1, IgG2, and IgG3, respectively. Less participants were assessed for IgG2 responses due to lack of sample volume which led to a limit on the number of repeats that the analysis lab could perform. Reportable results were not generated for the remaining participants post vaccination. |
| Breadth of T Cell Responses Analyzed by ELISPOT Assays | Baseline (Week 0), Week 26 and 50 | Breadth of T cell responses was assessed at baseline (Week 0), Week 26, and Week 50 by ELISPOT assays. |
| Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | At Week 24, 26, 48 and 50 | The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value \> limit of detection (LOD) if baseline \<LOD or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LOD. The lower limits of detection (LODs) for this assay were 4.28 (phagocytic score) for Mos1. |
| Percentage of Responders for HIV Neutralizing Antibody (nAb) | Week 64 | The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value \>LLOQ. |
| Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time | From Week 60 to Week 96 | The total HIV DNA levels were assessed as a biomarker of the HIV reservoir. |
Countries
Thailand
Participant flow
Pre-assignment details
Of the 37 participants screened for this study, 27 participants were randomized and received at least 1 dose of active vaccine (18 participants) or placebo (9 participants). One participant in the active vaccine group was excluded from the analysis on request of the Ethics Committee due to a major protocol deviation.
Participants by arm
| Arm | Count |
|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96. | 17 |
| Placebo Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96. | 9 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 27.4 years STANDARD_DEVIATION 5.39 | 27 years STANDARD_DEVIATION 5.83 | 26.3 years STANDARD_DEVIATION 6.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 26 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment THAILAND | 17 Participants | 26 Participants | 9 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 17 Participants | 26 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 9 |
| other Total, other adverse events | 15 / 17 | 7 / 9 |
| serious Total, serious adverse events | 1 / 17 | 0 / 9 |
Outcome results
Primary
Duration of Sustained Viremic Control With HIV RNA <50 Copies/mL During ATI Phase
Duration of sustained viremic control With HIV RNA \<50 copies/mL during ATI Phase was reported.
Time frame: From Week 60 to Week 96
Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Duration of Sustained Viremic Control With HIV RNA <50 Copies/mL During ATI Phase | 27.7 weeks |
Primary
Percentage of Participants With AEs
Percentage of participants with AEs were reported.
Time frame: Up to Week 52 (28 days after each vaccination)
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo. The data was planned for unsolicited AEs during the 28-day post-vaccination phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With AEs | 88.2 percentage of participants |
| Placebo | Percentage of Participants With AEs | 77.8 percentage of participants |
Primary
Percentage of Participants With AEs Leading to Discontinuation of Study Vaccination
Percentage of participants with AEs leading to discontinuation of study vaccination were reported.
Time frame: Up to Week 96
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With AEs Leading to Discontinuation of Study Vaccination | 0 percentage of participants |
| Placebo | Percentage of Participants With AEs Leading to Discontinuation of Study Vaccination | 0 percentage of participants |
Primary
Percentage of Participants With Grade 3 or 4 Related AEs
Related AEs of grade 3 or 4 and that is thought to be related to study vaccine were reported.
Time frame: Up to Week 52 (28 days after each vaccination)
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Grade 3 or 4 Related AEs | 0 percentage of participants |
| Placebo | Percentage of Participants With Grade 3 or 4 Related AEs | 0 percentage of participants |
Primary
Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs)
Solicited local AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.
Time frame: Up to Week 49 (7 days post each vaccination)
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs) | 0 percentage of participants |
| Placebo | Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs) | 0 percentage of participants |
Primary
Percentage of Participants With Grade 3 or 4 Solicited Systemic AEs
Solicited systemic AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching.
Time frame: Up to Week 49 (7 days post each vaccination)
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Grade 3 or 4 Solicited Systemic AEs | 0 percentage of participants |
| Placebo | Percentage of Participants With Grade 3 or 4 Solicited Systemic AEs | 0 percentage of participants |
Primary
Percentage of Participants With Grade 3 or 4 Unsolicited AEs
Unsolicited AE with worst severity grade 3 or 4 and that is thought to be related to study vaccine were reported. Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
Time frame: Up to Week 52 (28 days after each vaccination)
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Grade 3 or 4 Unsolicited AEs | 0 percentage of participants |
| Placebo | Percentage of Participants With Grade 3 or 4 Unsolicited AEs | 0 percentage of participants |
Primary
Percentage of Participants With Related AEs and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to Week 52 (28 days after each vaccination)
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Related AEs and Serious Adverse Events (SAEs) | Related AEs | 29.4 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Related AEs and Serious Adverse Events (SAEs) | Related SAEs | 0 percentage of participants |
| Placebo | Percentage of Participants With Related AEs and Serious Adverse Events (SAEs) | Related AEs | 0 percentage of participants |
| Placebo | Percentage of Participants With Related AEs and Serious Adverse Events (SAEs) | Related SAEs | 0 percentage of participants |
Primary
Percentage of Participants With Solicited Local AEs for 7 Days After Each Vaccination
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.
Time frame: Up to Week 49 (7 days post each vaccination)
Population: The Full Analysis Set (FAS) included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Solicited Local AEs for 7 Days After Each Vaccination | 88.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local AEs for 7 Days After Each Vaccination | 66.7 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic AEs for 7 Days After Each Vaccination
Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching were collected and reported for 7 days after each vaccination.
Time frame: Up to Week 49 (7 days after each vaccination)
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Solicited Systemic AEs for 7 Days After Each Vaccination | 70.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for 7 Days After Each Vaccination | 55.6 percentage of participants |
Primary
Percentage of Participants With Sustained Viremic Control (Human Immunodeficiency Virus [HIV] Ribonucleic Acid [RNA] Less Than [<]50 Copies Per Milliliter [Copies/mL]) During ATI Phase
Percentage of participants with sustained viremic control (HIV RNA \<50 copies/mL) during ATI phase were reported.
Time frame: From Week 60 to Week 96
Population: The primary Efficacy Population (EP) included all participants who started antiretroviral (ARV) ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Sustained Viremic Control (Human Immunodeficiency Virus [HIV] Ribonucleic Acid [RNA] Less Than [<]50 Copies Per Milliliter [Copies/mL]) During ATI Phase | 0 percentage of participants |
| Placebo | Percentage of Participants With Sustained Viremic Control (Human Immunodeficiency Virus [HIV] Ribonucleic Acid [RNA] Less Than [<]50 Copies Per Milliliter [Copies/mL]) During ATI Phase | 11.1 percentage of participants |
Primary
Percentage of Participants With Unsolicited AEs 28 Days After Each Vaccination
Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
Time frame: Up to Week 52 (28 days after each vaccination)
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Unsolicited AEs 28 Days After Each Vaccination | 88.2 percentage of participants |
| Placebo | Percentage of Participants With Unsolicited AEs 28 Days After Each Vaccination | 77.8 percentage of participants |
Primary
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Percentage of participants with worst laboratory toxicity grade 1 (mild) and non-graded hematology abnormalities were reported. Hematology parameters included absolute neutrophil count, basophils/leukocytes, eosinophils/leukocytes, hematocrit, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, erythrocytes, hematocrit, neutrophils, basophils, eosinophils, eosinophils/leukocytes, monocytes, neutrophils and platelet count. The parameters not represented in the grading scale, abnormalities were indicated as being 'high' or 'low' or 'abnormal'.
Time frame: Up to Week 96
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Eosinophils/Leukocytes (high) | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Basophils/Leukocytes (high) | 11.8 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Eosinophils/Leukocytes (high) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Hematocrit (low) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Lymphocytes/Leukocytes (high) | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Lymphocytes/Leukocytes (low) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Monocytes/Leukocytes (high) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Neutrophils/Leukocytes (low) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Absolute Neutrophil Count-Grade 1 | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Eosinophils/Leukocytes (low) | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Erythrocytes (low) | 17.6 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Hematocrit (low) | 23.5 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Lymphocytes/Leukocytes (high) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Lymphocytes/Leukocytes (low) | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Monocytes/Leukocytes (high) | 35.3 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Neutrophils (low) | 11.8 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Neutrophils/Leukocytes (low) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Basophils (high) | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Basophils/Leukocytes (high) | 11.8 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Eosinophils (high) | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Eosinophils (low) | 17.6 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Eosinophils/Leukocytes (high) | 11.8 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Eosinophils/Leukocytes (low) | 17.6 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Erythrocytes (high) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Erythrocytes (low) | 11.8 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Hematocrit (low) | 29.4 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Lymphocytes/Leukocytes (high) | 17.6 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Lymphocytes/Leukocytes (low) | 11.8 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Monocytes/Leukocytes (high) | 64.7 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Monocytes (high) | 11.8 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Neutrophils (low) | 41.2 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Neutrophils/Leukocytes (high) | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Neutrophils/Leukocytes (low) | 29.4 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Platelet count | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Hematocrit (low) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Absolute Neutrophil Count-Grade 1 | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Basophils (high) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Basophils/Leukocytes (high) | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Platelet count | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Eosinophils/Leukocytes (high) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Basophils/Leukocytes (high) | 25 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Hematocrit (low) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Lymphocytes/Leukocytes (high) | 25 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Lymphocytes/Leukocytes (high) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Eosinophils (high) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Lymphocytes/Leukocytes (low) | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Neutrophils (low) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Monocytes/Leukocytes (high) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Eosinophils (low) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | Post-Any Dose: Neutrophils/Leukocytes (low) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Lymphocytes/Leukocytes (low) | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Eosinophils/Leukocytes (high) | 33.3 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Eosinophils/Leukocytes (high) | 37.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Eosinophils/Leukocytes (low) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Neutrophils/Leukocytes (low) | 25 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Erythrocytes (low) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Eosinophils/Leukocytes (low) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Hematocrit (low) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Monocytes/Leukocytes (high) | 50 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Lymphocytes/Leukocytes (high) | 22.2 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Erythrocytes (high) | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Lymphocytes/Leukocytes (low) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Neutrophils/Leukocytes (high) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Monocytes/Leukocytes (high) | 44.4 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Erythrocytes (low) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Neutrophils (low) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ART resumption: Monocytes (high) | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities | ATI: Neutrophils/Leukocytes (low) | 22.2 percentage of participants |
Primary
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
Percentage of participants with worst laboratory grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening) and non-graded serum chemistry abnormalities were reported. Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, creatine, hyperglycemia, hypoglycemia, gamma-gutamyl transferase, chloride, urea nitrogen, and bilirubin. The parameters not represented in the grading scale, abnormalities were indicated as being 'high' or 'low' or 'abnormal'.
Time frame: Up to Week 96
Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | Post-Any Dose: Aspartate Aminotransferase- Grade 1 | 50 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ATP: Gamma Glutamyl Transferase (high) | 5.9 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Creatine- Grade 1 | 12.5 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ATP: Gamma Glutamyl Transferase (low) | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | Post-Any Dose: Aspartate Aminotransferase- Grade 4 | 50 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Chloride (High) | 18.8 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Hyperglycemia- Grade 1 | 6.3 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Gamma Glutamyl Transferase (Low) | 6.3 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Alanine Aminotransferase- Grade 1 | 12.5 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Urea Nitrogen (Low) | 12.5 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Hyperglycemia- Grade 2 | 6.3 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART Resumption: Bilirubin | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | Post-Any Dose: Alanine Aminotransferase- Grade 1 | 50 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | Post-Any Dose: Alanine Aminotransferase- Grade 3 | 50 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Hypoglycemia- Grade 1 | 0 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Aspartate Aminotransferase- Grade 1 | 12.5 percentage of participants |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Hypoglycemia- Grade 2 | 6.3 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART Resumption: Bilirubin | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Alanine Aminotransferase- Grade 1 | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Aspartate Aminotransferase- Grade 1 | 37.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Creatine- Grade 1 | 25 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Hyperglycemia- Grade 1 | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Hyperglycemia- Grade 2 | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Hypoglycemia- Grade 1 | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Hypoglycemia- Grade 2 | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ATP: Gamma Glutamyl Transferase (high) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ATP: Gamma Glutamyl Transferase (low) | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Chloride (High) | 12.5 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Gamma Glutamyl Transferase (Low) | 0 percentage of participants |
| Placebo | Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities | ART resumption: Urea Nitrogen (Low) | 0 percentage of participants |
Secondary
Breadth of T Cell Responses Analyzed by ELISPOT Assays
Breadth of T cell responses was assessed at baseline (Week 0), Week 26, and Week 50 by ELISPOT assays.
Time frame: Baseline (Week 0), Week 26 and 50
Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Breadth of T Cell Responses Analyzed by ELISPOT Assays | Baseline | 2.0 Median number of subpools |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Breadth of T Cell Responses Analyzed by ELISPOT Assays | Week 26 | 10.0 Median number of subpools |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Breadth of T Cell Responses Analyzed by ELISPOT Assays | Week 50 | 8.0 Median number of subpools |
| Placebo | Breadth of T Cell Responses Analyzed by ELISPOT Assays | Baseline | 3.5 Median number of subpools |
| Placebo | Breadth of T Cell Responses Analyzed by ELISPOT Assays | Week 26 | 3.0 Median number of subpools |
| Placebo | Breadth of T Cell Responses Analyzed by ELISPOT Assays | Week 50 | 3.0 Median number of subpools |
Secondary
Change in Cluster of Differentiation (CD)4 Count Over Time
Change in CD4 count over time was reported. Assessment of residual HIV replication and viral reservoir in total CD4+ T cells was measured by quantitative real-time polymerase chain reaction (PCR).
Time frame: Baseline and from Week 60 to Week 96
Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Change in Cluster of Differentiation (CD)4 Count Over Time | Baseline | 637 Median cells per cubic milliliters |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Change in Cluster of Differentiation (CD)4 Count Over Time | ATI | 602 Median cells per cubic milliliters |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Change in Cluster of Differentiation (CD)4 Count Over Time | ART | 661 Median cells per cubic milliliters |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Change in Cluster of Differentiation (CD)4 Count Over Time | Week 96 | 620 Median cells per cubic milliliters |
| Placebo | Change in Cluster of Differentiation (CD)4 Count Over Time | Week 96 | 538 Median cells per cubic milliliters |
| Placebo | Change in Cluster of Differentiation (CD)4 Count Over Time | Baseline | 531 Median cells per cubic milliliters |
| Placebo | Change in Cluster of Differentiation (CD)4 Count Over Time | ART | 618 Median cells per cubic milliliters |
| Placebo | Change in Cluster of Differentiation (CD)4 Count Over Time | ATI | 498 Median cells per cubic milliliters |
Secondary
Duration of Acute Retroviral Syndrome Post-ARV ATI
Duration of acute retroviral syndrome post-ARV ATI was reported.
Time frame: From Week 60 to Week 96
Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Duration of Acute Retroviral Syndrome Post-ARV ATI | NA weeks |
| Placebo | Duration of Acute Retroviral Syndrome Post-ARV ATI | NA weeks |
Secondary
Number of Participants With Acute Retroviral Syndrome Post-ARV ATI
Number of participants with acute retroviral syndrome post-ARV ATI were reported.
Time frame: From Week 60 to Week 96
Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Number of Participants With Acute Retroviral Syndrome Post-ARV ATI | 0 Participants |
| Placebo | Number of Participants With Acute Retroviral Syndrome Post-ARV ATI | 0 Participants |
Secondary
Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time
The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value \> limit of detection (LOD) if baseline \<LOD or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LOD. The lower limits of detection (LODs) for this assay were 4.28 (phagocytic score) for Mos1.
Time frame: At Week 24, 26, 48 and 50
Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | Week 24 | 4.500 percentage of ADCP gp antibody |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | Week 26 | 18.200 percentage of ADCP gp antibody |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | Week 48 | 10.500 percentage of ADCP gp antibody |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | Week 50 | 20.500 percentage of ADCP gp antibody |
| Placebo | Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | Week 50 | 0 percentage of ADCP gp antibody |
| Placebo | Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | Week 24 | 0 percentage of ADCP gp antibody |
| Placebo | Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | Week 48 | 0 percentage of ADCP gp antibody |
| Placebo | Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time | Week 26 | 0 percentage of ADCP gp antibody |
Secondary
Percentage of Participants With HIV Resistance to ARV Drugs Who Experienced Rebound Viremia After ARV ATI
Percentage of participants with HIV resistance to ARV drugs who experienced rebound viremia after ARV ATI were reported. An HIV genotype test was done to evaluate and characterize HIV resistance to ARV drugs in participants who experience rebound viremia after ARV ATI.
Time frame: From Week 60 to Week 96
Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Participants With HIV Resistance to ARV Drugs Who Experienced Rebound Viremia After ARV ATI | 35.3 percentage of participants |
| Placebo | Percentage of Participants With HIV Resistance to ARV Drugs Who Experienced Rebound Viremia After ARV ATI | 22.2 percentage of participants |
Secondary
Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody
Vaccine-induced binding antibody IgG1, IgG2, and IgG3 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQs for this assay were 12.3, 28.7, and 12.4, for IgG1, IgG2, and IgG3, respectively. Less participants were assessed for IgG2 responses due to lack of sample volume which led to a limit on the number of repeats that the analysis lab could perform. Reportable results were not generated for the remaining participants post vaccination.
Time frame: Week 50
Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab | 68.8 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody | HIV ENV (gp140 T) clade C (ZA) IgG-2 Ab | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab | 18.8 percentage of responders |
| Placebo | Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab | 0 percentage of responders |
| Placebo | Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab | 11.1 percentage of responders |
Secondary
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
The Env Clade A (92UG037), B (1990a), and C (Con C), (C97ZA.012) and Mos1- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline greater than or equal to (\>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, 156.25 and 78.125 endotoxin units per milliliter (EU/mL) for Clade A (92UG037), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012) and Mos1 respectively.
Time frame: At Week 24, 26, 48 and 50
Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 50 | 94.1 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 48 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 4 | 76.5 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 48 | 94.1 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 16 | 82.4 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 50 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 24 | 82.4 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 24 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 26 | 82.4 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 24 | 94.1 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab; Week 48 | 64.7 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 26 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 50 | 76.5 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 26 | 70.6 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 24 | 88.2 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 26 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) Mos1 IgG-t Ab; Week 26 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 48 | 82.4 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 48 | 94.1 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 50 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 50 | 94.1 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 24 | 100 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 24 | 11.1 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 48 | 11.1 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 24 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 48 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 24 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 48 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 4 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 16 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 24 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab; Week 48 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 24 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) Mos1 IgG-t Ab; Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers | HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 48 | 0 percentage of responders |
Secondary
Percentage of Responders for HIV Neutralizing Antibody (nAb)
The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value \>LLOQ.
Time frame: Week 64
Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders for HIV Neutralizing Antibody (nAb) | 100 percentage of responders |
| Placebo | Percentage of Responders for HIV Neutralizing Antibody (nAb) | 0 percentage of responders |
Secondary
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
Frozen peripheral blood mononuclear cell (PBMCs) was analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value \>P95 if baseline \<P95 or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study.
Time frame: At Week 24, 26, 48 and 50
Population: The Immunogenicity Population (IP) included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV10 pep subpool (PTE): Week 26 | 11.8 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Clinical PTE): Week 26 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Clinical PTE): Week 48 | 70.6 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Clinical PTE): Week 50 | 80.0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Mos1): Week 26 | 94.1 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Mos1): Week 50 | 100 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Mos2): Week 26 | 58.8 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Mos2): Week 50 | 66.7 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Clinical PTE): Week 24 | 70.6 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV10 pep subpool (PTE): Week 50 | 20.0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (Mos1): Week 26 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (Mos1): Week 50 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (Mos2): Week 26 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (Mos2): Week 50 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (PTE): Week 26 | 11.8 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (PTE): Week 50 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (Mos1): Week 26 | 5.9 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (Mos1): Week 50 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (Mos2): Week 26 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (Mos2): Week 50 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (PTE): Week 26 | 11.8 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (PTE): Week 50 | 6.7 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (Mos1): Week 26 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (Mos1): Week 50 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (Mos2): Week 26 | 21.4 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (Mos2): Week 50 | 6.7 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (PTE): Week 26 | 5.9 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (PTE): Week 50 | 0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV14 pep subpool (Mos1): Week 26 | 17.6 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV14 pep subpool (Mos1): Week 50 | 20.0 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV14 pep subpool (Mos2): Week 26 | 14.3 percentage of responders |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV14 pep subpool (Mos2): Week 50 | 6.7 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV14 pep subpool (Mos2): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Clinical PTE): Week 24 | 11.1 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (Mos1): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Clinical PTE): Week 26 | 22.2 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (Mos2): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Clinical PTE): Week 48 | 22.2 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (Mos1): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Clinical PTE): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV14 pep subpool (Mos1): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Mos1): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (Mos2): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Mos1): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (Mos2): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Mos2): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (Mos2): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV pep pool (Mos2): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV14 pep subpool (Mos2): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV10 pep subpool (PTE): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (PTE): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV10 pep subpool (PTE): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (PTE): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (Mos1): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV12 pep subpool (PTE): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (Mos1): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV14 pep subpool (Mos1): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (Mos2): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (Mos1): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (Mos2): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (PTE): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (PTE): Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV13 pep subpool (Mos1): Week 50 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 | HIV IFNg ENV11 pep subpool (PTE): Week 50 | 0 percentage of responders |
Secondary
Time to Reinitiating ART
Time to reinitiating ART was reported.
Time frame: Up to Week 96
Population: The primary EP included all participants who started ARV ATI at Week 60 (Stage 2), regardless of the time or outcome of treatment interruption.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Time to Reinitiating ART | 5.4 Weeks |
| Placebo | Time to Reinitiating ART | 4.5 Weeks |
Secondary
Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time
The total HIV DNA levels were assessed as a biomarker of the HIV reservoir.
Time frame: From Week 60 to Week 96
Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time | Start of ATI | 34.83 copies/10E6 cells | Standard Deviation 54.04 |
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time | 6 Months post ATI | 47.24 copies/10E6 cells | Standard Deviation 67.49 |
| Placebo | Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time | Start of ATI | 80.10 copies/10E6 cells | Standard Deviation 117.36 |
| Placebo | Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time | 6 Months post ATI | 80.00 copies/10E6 cells | Standard Deviation 72.52 |