An early-stage HIV vaccine clinical trial in South Africa has concluded that an investigational vaccine regimen was safe and generated comparable immune responses to those reported in a landmark 2009 study which showed that a vaccine could protect people from HIV infection.
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 called HVTN 702.
NIAID director Dr Anthony Stephen Fauci said for the first time in seven years, the scientific community was embarking on a large-scale clinical trial of an HIV vaccine, the product of years of study and experimentation.
He said a safe and effective HIV vaccine could help bring about a durable end to the HIV/AIDS pandemic and was particularly needed in Southern Africa, where HIV was more pervasive than anywhere else in the world.
The trial is scheduled to begin in November, pending regulatory approval.
The HVTN 702 study is designed to determine whether the regimen is safe, tolerable and effective at preventing HIV infection among South African adults.
The experimental vaccine regimen that will be studied in HVTN 702 was being tested in the smaller initial trial, HVTN 100, and was based on the regimen investigated in the US Military HIV Research Program-led RV144 clinical trial in Thailand that delivered landmark results in 2009.
NIAID is responsible for all operational aspects of the pivotal Phase 2b/3 trial, which will enroll 5 400 HIV-uninfected men and women aged from 18 to 35 years and who are at risk of HIV infection.
The NIAID-funded HIV Vaccine Trials Network (HVTN) will conduct the study. Results are expected in late 2020. The HVTN 702 study will be led by Protocol Chair Glenda Gray, a research professor of pediatrics at the University of the Witwatersrand, and a director of the Perinatal HIV Research Unit at the Chris Hani Baragwanath Hospital in Soweto.
Gray said the new study will determine whether the initial success observed in HVTN 100 will bear fruit in the form of a safe and effective HIV vaccine designed for the people of Southern Africa.
All study participants will receive a total of five injections over one year. They will be randomly assigned to receive either the investigational vaccine regimen or a placebo.
Should they become infected with HIV during the trial they will be referred to local medical providers for care and treatment and will be counselled on how to reduce their risk of transmitting the virus.
The NIAID conducts and supports research at research centre the National Institutes of Health (NIH), throughout the US, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.