NIH [to 21 May 2016]
http://www.nih.gov/news-events/news-releases

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May 18, 2016
Large-scale HIV vaccine trial to launch in South Africa
— NIH-funded study will test safety, efficacy of vaccine regimen.
An early-stage HIV vaccine clinical trial in South Africa has determined that an investigational vaccine regimen is safe and generates comparable immune responses to those reported in a landmark 2009 study showing that a vaccine can protect people from HIV infection.

onsequently, the National Institute of Allergy and Infectious Diseases (NIAID) and its partners have decided to advance the experimental HIV vaccine regimen into a large clinical trial. This 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. The trial is slated to begin in November 2016, pending regulatory approval.

“For the first time in seven years, the scientific community is embarking on a large-scale clinical trial of an HIV vaccine, the product of years of study and experimentation,” said Anthony S. Fauci, M.D., director of NIAID, part of the National Institutes of Health and a co-funder of the trial. “A safe and effective HIV vaccine could help bring about a durable end to the HIV/AIDS pandemic and is particularly needed in southern Africa, where HIV is more pervasive than anywhere else in the world.”

The experimental vaccine regimen that will be studied in HVTN 702 is now being tested in the smaller initial trial, named HVTN 100, and is based on the regimen investigated in the U.S. Military HIV Research Program-led RV144 clinical trial in Thailand that delivered landmark results in 2009. The current regimen is designed to provide greater protection than the RV144 regimen and has been adapted to the HIV subtype that predominates in southern Africa…

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 NIH statement on HIV Vaccine Awareness Day
May 18, 2016 — Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases.
[Excerpt]
… In this regard, today NIAID is pleased to announce the decision to move forward with HVTN 702, a new Phase 2b/3 HIV vaccine efficacy clinical trial in South Africa. The study will test an investigational HIV vaccine regimen designed to improve upon the efficacy observed in the RV144 trial in Thailand and to evaluate the vaccine in a higher risk population. RV144 is the only clinical trial to demonstrate that a vaccine can protect people from HIV infection, albeit to a modest degree.

The decision to proceed with HVTN 702 was informed by early data from the HVTN 100 phase 1/2 clinical trial, which has shown that the new vaccine regimen is safe and produces a robust immune response. HVTN 100 was led by the Pox-Protein Public-Private Partnership (P5), a diverse group of organizations including NIAID committed to building on the success of the RV144 HIV vaccine trial.

Vaccine research also continues 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. These so-called broadly neutralizing antibodies (bNAbs) can occur naturally; however, they occur in high titers in a relatively small proportion of infected individuals and they usually develop only after two or more years of infection, too late to be of significant benefit to the patient. However, if a vaccine could stimulate uninfected people’s immune systems to make bNAbs, the antibodies might protect those people from HIV infection.

Researchers are identifying and engineering numerous and more powerful types of bNAbs and testing them in clinical trials of passive infusion to see if they can protect uninfected people from acquiring HIV, and in HIV-infected people to see if they help keep the virus in check. Testing the ability of bNAbs in these settings will help demonstrate whether a vaccine that elicits similar antibodies or sets of antibodies can prevent HIV infection.

… HIV vaccine development has been challenging; however, the goal of developing a safe and effective vaccine that helps bring about a durable end to the HIV/AIDS pandemic is an overarching research priority. On this HIV Vaccine Awareness Day, we recognize and thank the thousands of HIV vaccine clinical trial volunteers, researchers, health professionals, advocates, and others who work in pursuit of that goal.