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HIV vaccine candidate enters phase 2b/3 trial
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A phase 2b/3 trial led by researchers at the National Institute of Allergy and Infectious Diseases will be the first of its kind in 7 years to assess the efficacy of an HIV vaccine candidate, according to a press release.
The HVTN 702 trial will be conducted across 15 sites in South Africa where 5,400 HIV-uninfected participants aged 18 to 35 years will randomly receive the investigational vaccine or placebo. Results are slated for the end of 2020.
“If deployed alongside our current armory of proven HIV prevention tools, a safe and effective vaccine could be the final nail in the coffin for HIV,” Anthony S. Fauci, MD, director of the NIAD, said in the release. “Even a moderately effective vaccine would significantly decrease the burden of HIV disease over time in countries and populations with high rates of infection, such as South Africa.”
The vaccine is based on a regimen that was evaluated in the RV144 trial, conducted in Thailand. Results from RV144, released in 2009, showed that the vaccine was 31.2% effective at preventing HIV over a follow-up period of 3.5 years. For the current trial, the vaccine was modified specifically for HIV subtype C, the predominant subtype in southern Africa.
“The people of South Africa are making history by conducting and participating in the first HIV vaccine efficacy trial to build on the results of the Thai trial,” Glenda Gray, MBBCH, FCPaed.(SA), president and chief executive officer of the South African Medical Research Council, founding director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital in Soweto, South Africa, and protocol chair for HVTN 702, said in the release. “HIV has taken a devastating toll in South Africa, but now we begin a scientific exploration that could hold great promise for our country. If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the epidemic.”
According to the release, the vaccine consists of a canarypox vector-based vaccine called ALVAC-HIV (Sanofi Pasteur), and a gp120 protein subunit vaccine with an adjuvant (MF59, GlaxoSmithKline) different from the one used in RV144 that researchers hope will generate a stronger immune response. The new regimen also includes two booster vaccines given 1 year after the initial vaccination. It was previously tested in a cohort of 252 participants from the HVTN 100 trial. Results from the trial showed the vaccine was safe and induced immune responses like those reported in RV144.
The HVTN 100 and HVTN 702 trials are part of a larger initiative led by the Pox-Protein Public-Private Partnership, or P5, which aims to better understand HIV immunity and develop a vaccine that could significantly benefit people living in southern Africa. Members of the P5 include the NIAID, the Bill & Melinda Gates Foundation, the South African Medical Research Council, HVTN, Sanofi Pasteur, GSK and the United States Military HIV Research Program.
Disclosure: Infectious Disease News was unable to confirm relevant financial disclosures at the time of publication.