HIV vaccine study stopped for being ineffective
ONE of South Africa’s biggest HIV vaccine efficacy studies, called HVTN 702/ Uhambo, has been stopped early after an independent data and safety monitoring board found the regimen was not effective.
Uhambo was the world’s first HIV vaccine efficacy study conducted in South Africa since 2009 to test whether an experimental vaccine regimen could safely prevent HIV infection among adults in South Africa.
The study enrolled 5 407 HIV-negative participants at 14 sites across South Africa.
They consisted of sexually active men and women aged 18 to 35.
Volunteers were randomly assigned to receive either the investigational vaccine regimen or placebo injections.
Six injections were administered to study participants over 18 months.
The safety of Uhambo was closely monitored throughout the trial, and participants were offered the local standard of care for preventing HIV, including access to oral pre-exposure prophylaxis.
The data and safety monitoring board examined data from 2 694 volunteers who received the investigational vaccine regimen and 2 689 volunteers who received the placebo injection.
In an interim analysis on January 23, 129 HIV infections occurred among the vaccine recipients, and 123 HIV infections occurred among the placebo recipients.
Protocol co-chairperson from the Perinatal HIV Research Unit based in Soweto, Dr Fatima Laher, said: “We remain deeply committed to the continued follow up of our participants and ensuring they continue to explore ways of preventing HIV in their everyday lives.
“The people of South Africa have made history by answering this important scientific question.”
President and chief executive of the Medical Research Council of SA and HVTN 702 Protocol chairperson, Professor Glenda Gray, said: “Sadly, we wish the answer was different.
“We will continue with our HIV vaccine programmes and other promising avenues for preventing HIV, both in South Africa and around the world.”
The South African National Aids Council (Sanac) said it was saddened by the discontinuation of the HVTN 702 Study.
“It is worth noting that South Africa has made significant progress in the HIV response since this trial began in 2016, and that we continue to be at the forefront in the global HIV research, progressive policy and best practice programme implementation,” Sanac said.
“Outcomes of the HVTN 702 Study are also not in vain; we can still draw many lessons to inform future trial endeavours,” it said.