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Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults.
- Source :
-
The New England journal of medicine [N Engl J Med] 2021 Mar 25; Vol. 384 (12), pp. 1089-1100. - Publication Year :
- 2021
-
Abstract
- Background: A safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox-protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1-2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa.<br />Methods: In this phase 2b-3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120-MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months.<br />Results: In January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70% of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month follow-up, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.81 to 1.30; Pā=ā0.84).<br />Conclusions: The ALVAC-gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity. (HVTN 702 ClinicalTrials.gov number, NCT02968849.).<br /> (Copyright © 2021 Massachusetts Medical Society.)
- Subjects :
- Adolescent
Adult
Canarypox virus
Double-Blind Method
Female
Genetic Vectors
Humans
Immunization, Secondary
Male
South Africa
Treatment Failure
Young Adult
AIDS Vaccines immunology
Adjuvants, Immunologic
HIV Infections prevention & control
HIV-1 genetics
Immunogenicity, Vaccine
Polysorbates
Squalene
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 384
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 33761206
- Full Text :
- https://doi.org/10.1056/NEJMoa2031499