A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
Condition: HIV-1
MeSH terms: Infections
Intervention: Ad26.Mos4.HIV; Clade C gp140; Placebo
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Sponsor will be also blinded
Enrollment: 2636.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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