CompletedPhase 2/3

Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa

South Africa5,404 participantsStarted 2016-10-26

Plain-language summary

This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over 24 months and potentially up to 36 months from enrollment.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Age of 18 to 35 years * Sexually active, defined as having had sexual intercourse at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for HIV infection. * Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study prior to first vaccination with verbal demonstration of understanding of all questions. * Agrees not to enroll in another study of an investigational research agent until the participant is unblinded or their study participation ends, whichever occurs last * Good general health as shown by medical history, physical exam, and screening laboratory tests * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling. * Alanine aminotransferase (ALT) \< 2.5 times the institutional upper limit of normal * Negative HIV-1 and -2 blood test within 30 days prior to enrollment: Sites may use locally available assays that have been approved by HVTN Laboratory Operations. * Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment

Timeframe: Measured through 24 months after first vaccination

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Timeframe: Measured through 3 full days following each vaccination

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Timeframe: Measured through 3 full days following each vaccination

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Timeframe: Measured through 3 full days following each vaccination

Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

Timeframe: Measured through 30 days after each vaccination

Number of Participants Reporting Adverse Events (AEs), by Severity Grade

Timeframe: Measured through 30 days after each vaccination

Trial details

NCT IDNCT02968849

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2021-11-16

Results submitted2022-11-16

View on ClinicalTrials.gov More HIV Infections trials