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NIH to Launch Large-Scale HIV Vaccine Trial


Pharmaceutical Executive

May 19, 2016.

The National Institutes of Health (NIH) says it has plans to launch a large-scale vaccine trial in South Africa. According to a May 18, 2016 press release, the National Institute of Allergy and Infectious Diseases (NIAID) and its partners have decided to advance an experimental HIV vaccine regimen into a large clinical trial. The new study, called HVTN 702 will determine whether the regimen is safe, tolerable, and effective at preventing the HIV infection, NIAID said. The trial will begin in November 2016, pending regulatory approval.

NIAID says the vaccine regimen is currently being tested in a smaller clinical trial, HVTN 100. The regimen is based on the regimen tested in the clinical trial RV144, which took place in Thailand in 2009 and was conducted by the US Military HIV Research Program. In 2009, the vaccine regimen was found to be 31.2% effective at preventing the infection 3.5 years post vaccination. The same regimen appeared to be 60% effective one-year post vaccination. NIH says the vaccine being tested in South Africa will provide greater protection, and has been adapted to HIV subtype C, the predominant subtype of HIV in South Africa.

The South African trial will enroll 5400 HIV-uninfected men and women, ages 18–35, who are at risk for infection, and the HIV Vaccines Trials Network will conduct the study. The HVTN 702 regimen consists of a canarypox-based vaccine called ALVAC-HIV, supplied by Sanofi Pasteur, and a bivalent gp120 protein subunit vaccine, supplied by GlaxoSmithKline, with an adjuvant. Participants in the trial will receive five injections over the course of a year. NIH says it expects the results of the study to be available by 2020.

Source: NIH


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