A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Efficacy Study of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-adjuvanted Clade C gp140 in Preventing HIV-1 Infection in Adult Women in Sub-Saharan Africa
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- HIV-1
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Enrollment
- 2636
- Locations
- 21
- Primary Endpoint
- Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment
Time Frame: 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
Time Frame: 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
Time Frame: 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
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 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
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 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.
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination
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 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
Time Frame: 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
Time Frame: 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 Fourth Vaccination
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product
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 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 Unsolicited AEs for 30 Days After Third Vaccination
Time Frame: 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.
Secondary Outcomes
- 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 36 (End of Study) Post Enrollment(Baseline up to Month 36 (End of study))
- 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 36 (End of Study) Post Enrollment(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)(Months 0, 7, 13 and 24)
- Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot)(Months 0, 7, 13 and 24)
- Number of Participants With Viral Sequences(Month 7 up to Month 24)