A clinical trial called HVTN 100 has been launched in South Africa to study an investigational HIV vaccine regimen for safety and the immune responses it generates in study participants. This experimental vaccine regimen is based on the one tested in the U.S. Military HIV Research Program-led
RV144 clinical trial in Thailand—the first study to demonstrate that a vaccine can protect people from HIV infection. The HVTN 100 vaccine regimen was designed to provide greater protection than the RV144 regimen and has been adapted to the HIV subtype that predominates in southern Africa. The results of the HVTN 100 trial, expected in two years, will help determine whether or not this vaccine regimen will be tested for efficacy in a large future study in South Africa.
“A safe and effective HIV vaccine is essential to reach a timely, sustained end to the HIV/AIDS pandemic,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. “The launch of HVTN 100 marks an important step forward in building upon the promising results of the RV144 trial to produce an HIV vaccine that could have a significant public health impact in southern Africa, where the HIV/AIDS pandemic is most pervasive.”
NIAID holds responsibility for all operational aspects of the Phase I/II trial, which has a target enrollment of 252 HIV-uninfected heterosexual adults ages 18 to 40. NIAID and The Bill and Melinda Gates Foundation are co-funding the study along with the South African Medical Research Council, and the NIAID-funded HIV Vaccine Trials Network (HVTN) is conducting the trial. Sanofi Pasteur and Novartis Vaccines manufactured the test vaccines for the study.
The HVTN 100 study is part of a larger HIV vaccine research endeavor led by a group called the Pox-Protein Public-Private Partnership, or the P5 — a diverse set of public and private organizations, including NIAID, committed to building on the success of RV144. The P5 aims to produce an HIV vaccine that could have a significant public health benefit in southern Africa and to deepen scientists’ understanding of the immune responses associated with preventing HIV infection.
Read the rest of the NIH press release HERE