The National Institute of Allergy and Infectious Diseases is sponsoring a landmark study in South Africa to test an experimental HIV vaccine. The clinical trials will begin this week at 15 different sites across the country.
HIV is a major health concern in South Africa; a 2007 report estimated that 5.7 million people—nearly 12% of South Africa’s population—had HIV or AIDS. In the adult population, this climbs to 18.5%. And it’s deadly—since not many can receive anti-retroviral therapy, an estimated 42-47% of all deaths in South Africa were related to HIV or AIDS.
The study being conducted is called HVTN 702, and will test 5,400 uninfected men and women ages 18 to 35 either two experimental vaccines or a placebo. Both groups will receive a total of five injections over the course of a year as well as standard education and care in preventing HIV infection.
The first of the vaccine candidates is ALVAC-HIV and is based on a canarypox vector. The second is a bivalent gp120 protein subunit vaccine with an adjuvant that enhances the body’s ability to create antibodies in response to vaccine exposure. Study participants will also receive booster shots one year afterward to see if an immune response can be prolonged.
The South African study is based on data from the RV144 clinical trial in Thailand, which found some success from their experimental vaccines. One year after the trial, the researchers found a 60 percent protective effect among participants. Three and a half years after the trial, the vaccine was found to be 31.2% effective.
This new trial will follow the vaccine regimen used in the Thai trial, but will adapt the vaccine to the HIV subtype most common in southern Africa. None of the vaccines will contain the HIV virus.
Researchers will also base the trial on data obtained in a smaller vaccine study in South Africa called HVTN 100. The recent study was the first that used the vaccines adapted to South Africa from the Thai study.
HIV vaccines have long been an elusive goal for scientists, due to HIV’s propensity to mutate quickly. But a small percentage of HIV-positive individuals naturally create broadly neutralizing antibodies (bNAbs) which can defeat many different strains of HIV. Vaccine research has therefore been focused on discovering how to create bNAbs in the laboratory and use them to prevent HIV infection.
Other recent or current studies into bNAb creation include the HVTN 704 study, which began in March 2016 in the United States. It is testing 2,700 men who have sex with other men living in the United States, South America, and Europe. Another major study is the HVTN 703 study, which began in June 2016 in South Africa. This study is testing 1,500 heterosexual women living in seven different sub-Saharan African countries.
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