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Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults
- Source :
- The New England journal of medicine. 384(12)
- 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. 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. 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; P = 0.84). 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.).
- Subjects :
- Adult
Male
Squalene
medicine.medical_specialty
Adolescent
Population
Genetic Vectors
Immunization, Secondary
Polysorbates
HIV Infections
030204 cardiovascular system & hematology
Canarypox virus
law.invention
03 medical and health sciences
South Africa
Young Adult
0302 clinical medicine
Immunogenicity, Vaccine
Randomized controlled trial
Adjuvants, Immunologic
Double-Blind Method
law
Internal medicine
medicine
Humans
030212 general & internal medicine
Treatment Failure
HIV vaccine
education
AIDS Vaccines
education.field_of_study
business.industry
General Medicine
Interim analysis
Vaccine efficacy
Vaccination
Regimen
AIDSVAX
HIV-1
Female
business
Subjects
Details
- ISSN :
- 15334406
- Volume :
- 384
- Issue :
- 12
- Database :
- OpenAIRE
- Journal :
- The New England journal of medicine
- Accession number :
- edsair.doi.dedup.....6fbe0fad196305adb7e7bbb1cc0f70e1