19th May, 2016
A United States of America Government health agency said on Thursday that a four-year clinical trial would soon begin in South Africa.
Anthony Fauci, the Director of NIAID, part of the U.S. National Institutes of Health and a co-founder of the trial made this known in Washington.
Fauci stated that the exercise was to test the safety and efficacy of a promising investigational HIV vaccine regimen.
He said pending regulatory approval, the new study, called HVTN 702 would take place at 15 sites in South Africa beginning in November.
He said a smaller initial trial in South Africa had determined that the regimen consisting of two experimental vaccines was safe and produced a robust immune response.
The founder said a safe and effective HIV vaccine could help bring about a durable end to the HIV/AIDS pandemic which was particularly needed in southern Africa where HIV was more pervasive than anywhere else in the world.
He said the results of the study to be led by Glenda Gray, the President and Chief Executive Officer of the South African Medical Research Council are expected in late 2020.
According to Fauci, 5,400 healthy men and women aged 18 to 35 years, who are at risk for HIV infection will be enrolled under the programme.
He said all study participants would receive a total of five injections over one year and they would be randomly assigned to receive either the investigational vaccine regimen or a placebo.
“The HVTN 702 vaccine regimen consists of two experimental vaccines: a canarypox-based vaccine called ALVAC-HIV and a bivalent gp120 protein subunit vaccine with an adjuvant that enhances the body’s immune response to the vaccine.
“The current regimen is modified from the one investigated in the U.S. Military HIV Research Program-led RV144 clinical trial in Thailand that delivered landmark results in 2009,” he said.
He stated that the experimental vaccine regimen tested in the RV144 trial was found to be 31.2 per cent effective at preventing HIV infection during the 3.5 years after vaccination.
Fauci said in the new study, the design and schedule of the RV144 vaccine regimen had been adjusted to try to increase the magnitude and duration of vaccine-elicited immune responses in South African adults.
“HVTN 702 will tell us whether the initial success will bear fruit in the form of a safe and effective HIV vaccine designed for the people of Southern Africa.”