Vaccine Regimen Fails to Prevent HIV-1 Infection in South Africa
WEDNESDAY, March 24, 2021 -- A canarypox-protein HIV vaccine regimen (ALVAC-HIV) plus bivalent subtype C gp120-MF59 adjuvant does not prevent HIV-1 infection among adults in South Africa, according to a study published in the March 25 issue of the New England Journal of Medicine.
Glenda E. Gray, M.B., B.Ch., from the Fred Hutchinson Cancer Research Center in Seattle, and colleagues randomly assigned 5,404 adults (median age, 24 years; 70 percent women) without HIV-1 infection to receive canarypox-protein HIV vaccine or placebo (2,704 and 2,700 participants, respectively) in a phase 2b-3 trial in South Africa. The vaccine regimen included injections of ALVAC-HIV at months 0 and 1 followed by ALVAC-HIV plus bivalent subtype C gp120-MF59 adjuvant booster injections at months 3, 6, 12, and 18.
The researchers found that at an interim analysis in January 2020, prespecified criteria for nonefficacy were met, and further vaccinations were subsequently halted. There was a similar incidence of adverse events in the vaccine and placebo groups. HIV-1 infection was diagnosed in 138 and 133 participants in the vaccine and placebo groups, respectively, during the 24-month follow-up (hazard ratio, 1.02; 95 percent confidence interval, 0.81 to 1.30; P = 0.84).
"Despite promising immunogenicity, this canarypox-protein HIV vaccine regimen was not efficacious in preventing the acquisition of HIV-1 infection in our trial population in South Africa," the authors write. "The high HIV-1 incidence that we observed in our trial illustrates the unrelenting aspect of the epidemic, especially among young women."
The study was funded by Novartis Vaccines and Diagnostics, now part of GlaxoSmithKline Biologicals, which also contributed financially to the provision of preexposure prophylaxis to trial participants.
© 2021 HealthDay. All rights reserved.
Posted: March 2021
Read this next
TUESDAY, April 20, 2021 -- During the pandemic, there has been a decrease in total and measles-containing vaccines in all children, according to a study published online April 15...
MONDAY, April 19, 2021 -- Moderna says a third booster shot for its two-dose COVID-19 vaccine will be available in the United States by the fall. The announcement was made by...
MONDAY, April 19, 2021 -- Medicare patients of female physicians are more likely than patients of male physicians in the same practice to receive the influenza vaccine, according...
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.