20 May 2016
A successful early-stage HIV vaccine clinical trial in South Africa has prompted the expansion of the experimental vaccine regimen into a large clinical trial.
The new study, called HVTN 702, is designed to determine whether the regimen is safe, tolerable and effective at preventing HIV infection among South African adults. It will use a new variation of the RV144 shot, an experimental HIV vaccine developed by the US’s National Institute of Allergy and Infectious Diseases (Niaid). The drug will be trialled in South Africa at the end of 2016.
— IAVI (@IAVI) May 18, 2016
The HVTN 702 study will be led by Protocol Chair Dr Glenda Gray. Gray is the president and CEO of the South African Medical Research Council, research professor of paediatrics at the University of the Witwatersrand, Johannesburg, and a director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital in Soweto, South Africa.
According to a post on the Niaid website by its director, Dr Anthony Fauci, RV144 promises to be able to cut HIV viral infections by a third, even more when the vaccine is tested in a real-world environment. Fauci is one of the global leaders in searching for a viable and affordable solution to the HIV/Aids pandemic.
He says the new RV144 variation has been the most feasible vaccine ever developed. The trial will be one of largest single clinical testing processes done in South Africa.
Niaid, co-funder of the trial, falls under the US National Institutes of Health, an agency of the United States Department of Health. It is responsible for global biomedical and health-related research, particularly in communicable diseases and life-threatening allergies.
“A safe and effective HIV vaccine could help bring about a durable end to the HIV/Aids pandemic,” Fauci writes in the post, adding that “(it) is particularly needed in southern Africa, where HIV is more pervasive than anywhere else in the world.” /p>
In 2009, an early variation of the vaccine, developed by the US military, was trialled in Thailand. It consisted of a two-vaccine combination that cut the risk of HIV infection by 31% over three-and-a-half years.
A small safety trial in South Africa of the latest variation found the new modified shots promising enough to warrant an expanded study in November 2016, pending regulatory approval.
The South African trial will use 5 400 adult volunteers, each receiving five injections over a year, either vaccine or placebo shots. Results of the trial will be analysed and are expected to be released towards late 2020.
“While we are making encouraging (overall) progress (in the fight against the disease) – new HIV infections have fallen by 35% globally since 2000 – the development of a safe and effective HIV vaccine would be the ultimate game- changer,” Fauci writes. The new design and schedule of the vaccine regimen scheduled for the South African trial have been adjusted to try to increase the magnitude and duration of vaccine-elicited immune responses.
“Vaccine research (will) also continue in the laboratory, where scientists are investigating the use of potent antibodies that block a high percentage of global HIV strains from infecting human cells.”
In May 2016, South African Health Minister Aaron Motsoaledi announced that antiretroviral medicine would be made available to all HIV-positive people irrespective of their CD4 count by September. An extra R1-billion has been allocated to the health budget to make this programme possible.
Watch a full presentation by Fauci on the new trial and HIV/Aids research work done by the National Institute of Allergy and Infectious Diseases.