New clinical trial underway to study efficacy of HIV vaccine

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The study will be the largest HIV vaccine clinical trial to take place in South Africa.
The study will be the largest HIV vaccine clinical trial to take place in South Africa.

A phase IIb/III clinical trial is underway in South Africa to test the efficacy of the first HIV vaccine in 7 years. The study, known as HVTN 702 (ClinicalTrials.gov Identifier: NCT02968849), is testing an experimental HIV vaccine, based on the vaccine previously investigated in the RV144 clinical trial in Thailand (ClinicalTrials.gov Identifier: NCT00223080).1

The HVTN 702 study aims to enroll 5400 HIV-uninfected, sexually active men and women aged 18 to 35 years. The vaccine regimen consists of 2 experimental vaccines: a canarypox vector-based vaccine called ALVAC-HIV (Sanofi Pasteur) and a 2-component gp120 protein subunit vaccine (GlaxoSmithKline). These 2 experimental vaccines were used in RV144, but have been modified to be specific to HIV subtype C, the predominant HIV subtype in southern Africa.

Participants in the study will be randomly assigned to receive either the experimental vaccine regimen or a placebo. A total of 5 injections will be administered over 1 year. Researchers, hoping to obtain a more robust immune response, have combined the vaccine with MF59 (GlaxoSmithKline), a different adjuvant than was used in RV144. The HVTN 702 vaccine regimen will also include a booster shot at the 1-year mark to “prolong the early protective effect observed in RV144.”

“HVTN 702 begins just months after interim results were reported for HVTN 100, its predecessor clinical trial (ClinicalTrials.gov Identifier: NCT02404311), which found that the new vaccine regimen was safe for the 252 study participants and induced comparable immune responses to those reported in RV144,” according to the press release. 

“The people of South Africa are making history by conducting and participating in the first HIV vaccine efficacy study to build on the results of the Thai trial,” said Protocol Chair Glenda Gray, MBBCh, FCPaed, president and chief executive officer of the South African Medical Research Council. “If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the pandemic.”

This study, funded by the National Institute of Allergy and Infectious Diseases, is being conducted in 15 sites across South Africa. Results are expected by late 2020.

Reference

  1. First new HIV vaccine efficacy study in seven years has begun [news release]. Bethesda, MD: National Institutes of Health; Published November 28, 2016.
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