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National Institutes of Health terminates HIV vaccine after it proves ineffective

Published on 04/02/20 at 11:21am

A trial investigating the efficacy  of a new HIV vaccine conducted by the National Institute of Allergy and Infectious Diseases (NIAID), a branch of the National Institutes of Health, has been halted with no further vaccinations planned following review by an independent data and safety monitoring board which suggested it was not effective.

Launched in 2016 across 14 sites in South Africa, the Phase 2b/3 trial enrolled 5,407 sexually active male and female patients between 18 and 35 and randomised them to receive six injections of either the vaccine regimen or placebo over 18 months.

At the interim analysis of the trial in January this year, conducted once 60% of the participants had received treatment for 18 months, the monitoring board found that there were 129 cases of HIV injection in those receiving the vaccine and 123 cases in those with placebo.

Despite the DSMB’s findings that the vaccine was ineffective with no evidence that it promoted or inhibited infection rates, it did not report any concerns around its safety.

The vaccine was adapted from a regimen tested in trial RV144 – the only such therapy shown to protect against HIV – to cover HIV subtype Clade C, the most common form present across Southern Africa.

“An HIV vaccine is essential to end the global pandemic, and we hoped this vaccine candidate would work. Regrettably, it does not,” said NIAID Director Dr Anthony S Fauci. “Research continues on other approaches to a safe and effective HIV vaccine, which I still believe can be achieved.”

Protocol Chair for the trial, Glenda Gray, added: “The people of South Africa have made history by answering this important scientific question. Sadly, we wish the answer was different. We will continue to explore promising avenues for preventing HIV with other vaccines and tools, both in South Africa and around the world.”

Matt Fellows

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