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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,636
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.
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.
Participants will receive matching placebo.
UNC Lilongwe Project
Lilongwe, Malawi
Polana Caniço Health Research and Training Center (CISPOC)
Maputo, Mozambique
Josha Research
Bloemfontein, South Africa
Masiphumelele Research Centre
Cape Town, South Africa
Ndlovu Elandsdoorn Site
Dennilton, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Diepkloof, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Johannesburg, South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
Klerksdorp, South Africa
Qhakaza Mbokodo Research Centre
KwaZulu-Natal, South Africa
South African Medical Research Council Chatsworth Clinical Research Site
KwaZulu-Natal, South Africa
...and 13 more locations
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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
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)
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
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.
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Time frame: Months 0, 7, 13 and 24
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