HIV-1
Conditions
Brief summary
The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.
Interventions
BIOLOGICALAd26.Mos4.HIV
Participants will receive Ad26.Mos4.HIV 5x10\^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) into the left deltoid on Months 0, 3, 6, and 12.
BIOLOGICALClade C gp140
Participants will receive Clade C gp140 (250 mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
BIOLOGICALPlacebo
Participants will receive matching placebo.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Sponsor will be also blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Sexually active, defined as having had sexual intercourse with a male partner at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for Human Immunodeficiency Virus (HIV) infection * Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Sites (CRS) and willingness to be followed for the planned duration of the study * Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling and appropriate referrals to minimize HIV acquisition, as applicable * Negative beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing * Participants must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination
Exclusion criteria
* Investigational research agents received within 30 days before first vaccination * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 705/HPX2008 (Protocol Safety Review Team) PSRT will determine eligibility on a case-by-case basis * Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (example: measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever) * Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (example, tetanus, pneumococcal, Hepatitis A or B) * Immunosuppressive medications received within 6 months before first vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product | Up to Month 36 (up to end of the study) | Percentage of participants with AEs leading to early participant withdrawal or early discontinuation of study product were reported. An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with this treatment. |
| Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) | Percentage of participants with systematic reactogenicity signs and symptoms after fourth vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. |
| Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination | 30 days after first vaccination on Day 0 (Up to Day 30) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. |
| Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination | 30 days after second vaccination on Day 84 (Up to Day 114) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. |
| Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination | 30 days after third vaccination on Day 168 (Up to Day 198) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. |
| Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination | 30 days after fourth vaccination on Day 364 (Up to Day 394) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension. |
| Percentage of Participants With Serious Adverse Events (SAEs) | Up to Month 36 (up to end of the study) | An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose 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, is a suspected transmission of any infectious agent via a medicinal product. |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | Up to Month 36 (up to end of the study) | Percentage of participants with AESIs was reported. Immune-mediated diseases were considered as AESIs in this study. |
| Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | Month 7 up to Month 24 | Number of participants with HIV-1 infection diagnosed between Month 7 to Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | Up to 7 days after first vaccination on Day 0 (Day 7) | Percentage of participants with local reactogenicity signs and symptoms after first vaccination were reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | Up to 7 days after second vaccination on Day 84 (Day 91) | Percentage of participants with local reactogenicity signs and symptoms after second vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | Up to 7 days after third vaccination on Day 168 (Up to Day 175) | Percentage of participants with local reactogenicity signs and symptoms after third vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | Up to 7 days after fourth vaccination on Day 364 (Up to Day 371) | Percentage of participants with local reactogenicity signs and symptoms after fourth vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site. |
| Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination | Up to 7 days after first vaccination on Day 0 (Day 7) | Percentage of participants with systematic reactogenicity signs and symptoms after first vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. |
| Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination | Up to 7 days after second vaccination on Day 84 (Day 91) | Percentage of participants with systematic reactogenicity signs and symptoms after second vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. |
| Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination | Up to 7 days after third vaccination on Day 168 (Up to Day 175) | Percentage of participants with systematic reactogenicity signs and symptoms after third vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment | Baseline up to Month 36 (End of study) | Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through Month 36 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment | Month 13 up to Month 24 | Number of participants with HIV-1 infection diagnosed from Month 13 through Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment | Month 13 up to Month 36 (End of study) | Number of participants with HIV-1 infection diagnosed from Month 13 through Month 36 (end of study) post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Months 0, 7, 13 and 24 | A weighted geometric mean of the binding antibody responses to HIV envelope (ENV) gp140 Clade C 97ZA protein analyzed by ELISA was reported. |
| Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Months 0, 7, 13 and 24 | Geometric mean of IFN-gamma T-cells responses analyzed by ELISpot were reported. A weighted geometric mean of the number of spot-forming cells (SFC) per million peripheral blood mononuclear cells (PBMCs) producing Interferon-gamma upon stimulation with potential T-cell epitope (PTE) ENV peptide pools analyzed by ELISpot was reported. Reported responses are the sum of the number of SFCs/10\^6 PBMCS for PTE Env1, Env2 and Env3 sub-pools. |
| Number of Participants With Viral Sequences | Month 7 up to Month 24 | Number of participants with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 ribose nucleic acid polymerase chain reaction (RNA PCR) tests from study participants who were diagnosed with HIV-1 infection. |
| Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment | Baseline up to Month 24 | Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections. |
Countries
Malawi, Mozambique, South Africa, Zambia, Zimbabwe
Participant flow
Pre-assignment details
For Participant Flow below, data were summarized based on assigned treatment.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Ad26.Mos.HIV Vaccine Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5\*10\^10 virus particles (vp) per 0.5 milliliter (mL) via Intramuscular (IM) injection at Months 0, 3, 6, and 12 and Clade C glycoprotein (gp) 140 (250 \[micrograms\] mcg) mixed with aluminum phosphate adjuvant 425 mcg per 0.5 mL IM injection at Months 6 and 12. | 1,313 |
| Group 2: Placebo Participants received Placebo matching to Ad26.Mos4.HIV as 0.5 mL via IM injection at Months 0, 3, 6, and 12 and Placebo matching to Clade C gp140/aluminum phosphate adjuvant as 0.5 mL IM injection at Months 6 and 12. | 1,323 |
| Total | 2,636 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 5 |
| Overall Study | Investigator Decision | 7 | 7 |
| Overall Study | Other | 4 | 4 |
| Overall Study | Participant Relocate | 15 | 15 |
| Overall Study | Study Terminated by Sponsor | 1,100 | 1,123 |
| Overall Study | Unable to Adhere to Visit Schedule | 21 | 23 |
| Overall Study | Unable to Contact Participant | 34 | 23 |
| Overall Study | Withdrawal by Subject | 50 | 35 |
Baseline characteristics
| Characteristic | Group 1: Ad26.Mos.HIV Vaccine | Group 2: Placebo | Total |
|---|---|---|---|
| Age, Continuous | 22 years | 23 years | 23 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1313 Participants | 1323 Participants | 2636 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 1302 Participants | 1317 Participants | 2619 Participants |
| Race/Ethnicity, Customized Colored/Mixed | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Indian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment MALAWI | 78 Participants | 79 Participants | 157 Participants |
| Region of Enrollment MOZAMBIQUE | 23 Participants | 22 Participants | 45 Participants |
| Region of Enrollment SOUTH AFRICA | 882 Participants | 892 Participants | 1774 Participants |
| Region of Enrollment ZAMBIA | 164 Participants | 165 Participants | 329 Participants |
| Region of Enrollment ZIMBABWE | 166 Participants | 165 Participants | 331 Participants |
| Sex: Female, Male Female | 1313 Participants | 1323 Participants | 2636 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 1,317 | 4 / 1,319 |
| other Total, other adverse events | 798 / 1,317 | 806 / 1,319 |
| serious Total, serious adverse events | 49 / 1,317 | 37 / 1,319 |
Outcome results
Primary
Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment
Number of participants with HIV-1 infection diagnosed between Month 7 to Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time frame: Month 7 up to Month 24
Population: Per protocol (PP) population set included participants from the full analysis set (FAS; all randomized participants who received at least one study vaccine administration) who were HIV-1 uninfected 4 weeks after the third vaccination visit, who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows and had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | 54 Participants |
| Group 2: Placebo | Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment | 65 Participants |
Primary
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Percentage of participants with AESIs was reported. Immune-mediated diseases were considered as AESIs in this study.
Time frame: Up to Month 36 (up to end of the study)
Population: FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Adverse Events of Special Interest (AESIs) | 0.2 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Adverse Events of Special Interest (AESIs) | 0.2 Percentage of participants |
Primary
Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product
Percentage of participants with AEs leading to early participant withdrawal or early discontinuation of study product were reported. An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Month 36 (up to end of the study)
Population: FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product | 0.2 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product | 0.2 Percentage of participants |
Primary
Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination
Percentage of participants with local reactogenicity signs and symptoms after first vaccination were reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Time frame: Up to 7 days after first vaccination on Day 0 (Day 7)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | 34.2 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination | 9.4 Percentage of participants |
Primary
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination
Percentage of participants with local reactogenicity signs and symptoms after fourth vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Time frame: Up to 7 days after fourth vaccination on Day 364 (Up to Day 371)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | 25.7 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination | 8.6 Percentage of participants |
Primary
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination
Percentage of participants with local reactogenicity signs and symptoms after second vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Time frame: Up to 7 days after second vaccination on Day 84 (Day 91)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | 20.0 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination | 8.1 Percentage of participants |
Primary
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination
Percentage of participants with local reactogenicity signs and symptoms after third vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Time frame: Up to 7 days after third vaccination on Day 168 (Up to Day 175)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | 25.2 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination | 8.9 Percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose 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, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to Month 36 (up to end of the study)
Population: FAS included all randomized participants who received at least 1 vaccine administration. The safety analyses were performed based on the actual treatment that the participants received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Serious Adverse Events (SAEs) | 3.7 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Serious Adverse Events (SAEs) | 2.8 Percentage of participants |
Primary
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination
Percentage of participants with systematic reactogenicity signs and symptoms after first vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Time frame: Up to 7 days after first vaccination on Day 0 (Day 7)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination | 52.9 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination | 40.9 Percentage of participants |
Primary
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination
Percentage of participants with systematic reactogenicity signs and symptoms after fourth vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Time frame: Up to 7 days after fourth vaccination on Day 364 (Up to Day 371)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination | 29.4 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination | 23.6 Percentage of participants |
Primary
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination
Percentage of participants with systematic reactogenicity signs and symptoms after second vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Time frame: Up to 7 days after second vaccination on Day 84 (Day 91)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination | 33.2 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination | 28.6 Percentage of participants |
Primary
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination
Percentage of participants with systematic reactogenicity signs and symptoms after third vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Time frame: Up to 7 days after third vaccination on Day 168 (Up to Day 175)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination | 31.5 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination | 26.8 Percentage of participants |
Primary
Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Time frame: 30 days after first vaccination on Day 0 (Up to Day 30)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. The safety analyses were performed based on the actual treatment that the participants received after the first vaccination. Hence, one participant from Group 2 was analyzed in Group 1 for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination | 16.6 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination | 14.8 Percentage of participants |
Primary
Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Time frame: 30 days after fourth vaccination on Day 364 (Up to Day 394)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination | 63.5 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination | 62.5 Percentage of participants |
Primary
Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Time frame: 30 days after second vaccination on Day 84 (Up to Day 114)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination | 17.1 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination | 15.1 Percentage of participants |
Primary
Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Time frame: 30 days after third vaccination on Day 168 (Up to Day 198)
Population: FAS included all randomized participants who received at least 1 vaccine administration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination | 39.8 Percentage of participants |
| Group 2: Placebo | Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination | 40.3 Percentage of participants |
Secondary
Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA)
A weighted geometric mean of the binding antibody responses to HIV envelope (ENV) gp140 Clade C 97ZA protein analyzed by ELISA was reported.
Time frame: Months 0, 7, 13 and 24
Population: FIS included participants in the FAS who were HIV-1 uninfected 4 weeks after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Month 24 | 5920 ELISA Units per milliliter (EU/mL) |
| Group 1: Ad26.Mos.HIV Vaccine | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Month 7 | 38834 ELISA Units per milliliter (EU/mL) |
| Group 1: Ad26.Mos.HIV Vaccine | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Month 0 | 53 ELISA Units per milliliter (EU/mL) |
| Group 1: Ad26.Mos.HIV Vaccine | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Month 13 | 66147 ELISA Units per milliliter (EU/mL) |
| Group 2: Placebo | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Month 0 | 43 ELISA Units per milliliter (EU/mL) |
| Group 2: Placebo | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Month 24 | 49 ELISA Units per milliliter (EU/mL) |
| Group 2: Placebo | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Month 13 | 62 ELISA Units per milliliter (EU/mL) |
| Group 2: Placebo | Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA) | Month 7 | 43 ELISA Units per milliliter (EU/mL) |
Secondary
Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
Geometric mean of IFN-gamma T-cells responses analyzed by ELISpot were reported. A weighted geometric mean of the number of spot-forming cells (SFC) per million peripheral blood mononuclear cells (PBMCs) producing Interferon-gamma upon stimulation with potential T-cell epitope (PTE) ENV peptide pools analyzed by ELISpot was reported. Reported responses are the sum of the number of SFCs/10\^6 PBMCS for PTE Env1, Env2 and Env3 sub-pools.
Time frame: Months 0, 7, 13 and 24
Population: FIS included participants who were HIV-1 uninfected 4 week after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Month 0 | 33.5 SFC/million PBMCs |
| Group 1: Ad26.Mos.HIV Vaccine | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Month 7 | 241.2 SFC/million PBMCs |
| Group 1: Ad26.Mos.HIV Vaccine | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Month 13 | 287.1 SFC/million PBMCs |
| Group 1: Ad26.Mos.HIV Vaccine | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Month 24 | 172.7 SFC/million PBMCs |
| Group 2: Placebo | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Month 24 | 30.8 SFC/million PBMCs |
| Group 2: Placebo | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Month 13 | 33.2 SFC/million PBMCs |
| Group 2: Placebo | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Month 0 | 30.0 SFC/million PBMCs |
| Group 2: Placebo | Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) | Month 7 | 33.9 SFC/million PBMCs |
Secondary
Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment
Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time frame: Baseline up to Month 24
Population: Modified Intent-to-Treat (MITT) analysis set included participants in the FAS who were HIV-1 uninfected on the date of first vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment | 91 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment | 102 Participants |
Secondary
Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment
Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through Month 36 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time frame: Baseline up to Month 36 (End of study)
Population: MITT analysis set included participants in the FAS who were HIV-1 uninfected on the date of first vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment | 115 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment | 127 Participants |
Secondary
Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment
Number of participants with HIV-1 infection diagnosed from Month 13 through Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time frame: Month 13 up to Month 24
Population: Full immunization set (FIS) included participants in the FAS who were HIV-1 uninfected 4 week after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment | 32 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment | 35 Participants |
Secondary
Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment
Number of participants with HIV-1 infection diagnosed from Month 13 through Month 36 (end of study) post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time frame: Month 13 up to Month 36 (End of study)
Population: FIS included participants in the FAS who were HIV-1 uninfected 4 week after the fourth vaccination visit and who received all planned vaccinations within the respective visit windows.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment | 53 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment | 58 Participants |
Secondary
Number of Participants With Viral Sequences
Number of participants with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 ribose nucleic acid polymerase chain reaction (RNA PCR) tests from study participants who were diagnosed with HIV-1 infection.
Time frame: Month 7 up to Month 24
Population: PP population set included participants from the FAS; all randomized participants who received at least one study vaccine administration) who were HIV-1 uninfected 4 weeks after the third vaccination visit, who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows and had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos.HIV Vaccine | Number of Participants With Viral Sequences | 51 Participants |
| Group 2: Placebo | Number of Participants With Viral Sequences | 63 Participants |