Consequently, the National Institute of Allergy and Infectious Diseases (NIAID) and its partners have made a decision to advance the experimental HIV vaccine regimen into a large clinical trial.
The trial is set to begin by enroling the first 5,400 individuals aged 18 to 35 years old.
According to the United States National Institute of Allergy and Infectious Diseases (NIAID), the study, called HVTN 702, is to test whether an experimental vaccine regimen safely prevents infection among South African adults. One strategy builds on a 2009 Thai clinical trial in which an HIV vaccine reduced HIV infection rates among participants by about 31%. Although the Thai vaccine trial did not prevent enough infections to allow it to be marketed, it was the first trial to indicate that an HIV vaccine was possible.
The new vaccine aims to provide greater and more sustained protection and has been adapted to the HIV subtype that is rife in southern Africa. Barring any unforeseen problems or astounding success sooner, results from the new HIV vaccine trial are not expected until 2020.
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Glenda Gray, chief executive officer of the South African Medical Research Council told the AP, "HIV has taken a devastating toll in South Africa, but now we begin a scientific exploration that could hold great promise for our country". It involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus.
South Africa has been especially hard hit by HIV and AIDS-nearly twenty percent of the population, or 7 million people, is infected, and in some parts of the country, such as in the province of KwaZulu-Natal, estimates place the number of HIV-positive people at almost 30 percent. Their health will be closely monitored for two years, and the test subjects will continue to receive instruction on personal care to help prevent contraction of HIV. Finally, the HVTN 702 vaccine regimen will include booster shots at the one-year mark in an effort to prolong the early protective effect observed in RV144. The subjects of this trial will be given a total of five injections over one year.
The study volunteers are being randomly assigned to receive either the investigational vaccine regimen or a placebo. Anyone taking part who does become infected will be offered medical treatment and information on how to reduce the risk of them transmitting the virus.
HVTN 702 is being funded to the tune of $130m, with the bulk of that money coming from the NIAID and BMGF.