HIV/AIDS
Conditions
Interventions
Treatment
Placebo 2 (P2)
Sponsors
Janssen Vaccines & Prevention B.V.
Eligibility
Sex/Gender
Female
Inclusion 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 (betaHCG) 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
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 other than influenza vaccine 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); Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B); Immunosuppressive medications received within 6 months before first vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine Efficacy (VE) as Derived From Confirmed HIV1 Infections Diagnosed Between the Month 7 and Month 24 Visits;Local and systemic reactogenicity signs and symptoms for 3 days after each vaccination, adverse events for 30 days after each vaccination, and serious adverse events, AESIs, and adverse events leading to early participant withdrawal or early discontinuation of study product(s) administration for the entire duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between Enrollment and the Month 24 Visit;Vaccine efficacy as derived from confirmed HIV-1 infection diagnosed after enrollment through the end of the study if Stage 2 occurs;Vaccine Efficacy as Derived From Confirmed HIV1 Infections Diagnosed Between the Month 12 and the Month 24 Visits;Vaccine efficacy as derived from confirmed HIV-1 infection diagnosed from month 12 through the end of the study if Stage 2 occurs;Immunogenicity of the Vaccine Regimen;Immunogenicity and Immune Response Biomarkers as Correlates of Risk of Subsequent HIV Acquisition;Vaccine Efficacy Assessed by Various Baseline and Demographic Characteristics;Genotypic Characteristics of Viral Sequences From HIV1 Infected Participants at HIV1 Diagnosis, Such as Signature Site Mutations;Comparison of Genomic Sequences of Viral Isolates From HIV1 Infected Vaccine and Placebo Recipients and Assessment by Sieve Analysis Methods of Whether There is Evidence of VaccineInduced Immune Pressure on the Viral Sequences | — |
Countries
Malawi, Mozambique, South Africa, Zambia, Zimbabwe
Contacts
Public ContactLorenz Scheppler
Global Regulatory Leader, HIV & HPV Vaccines
Outcome results
None listed