A $130m SA-based study of a promising vaccine for HIV has ended in failure after an interim analysis showed it was no more effective than placebo, The Washington Post reports researchers have announced. Vaccinations were halted after an independent monitoring panel for the “Uhambo” study in South Africa determined on 23 January that 129 people who received the vaccine developed HIV while 123 who were given a placebo contracted the infection.
“It’s disappointing, but I’m not overly surprised by it,” said Dr Anthony S Fauci, director of the US National Institute of Allergy and Infectious Diseases (NIAID), which funded the $130m research effort with the Bill & Melinda Gates Foundation. “It did not, essentially, bring it over the goal line.”
The report says the trial began on a hopeful note in 2016. It tested a modified version of a vaccine that had proven 31% effective in 16,000 people in Thailand four years earlier — too modest an impact for use in a general population but effective enough to warrant further study.
The combination of two drugs was reformulated to attack the version of the virus that circulates in South Africa, where nearly 1 in 5 adults are infected, in the hope of boosting its effectiveness to about 50%. That would have made production of the vaccine worthwhile for the two companies, Sanofi Pasteur and GSK, experts said.
The report says the study was only the seventh large-scale human trial of a vaccine for HIV, which newly infected 1.7m people worldwide in 2018, according to the Joint United Nations Programme on HIV and Aids. Researchers enrolled more than 5,400 sexually active men and women between the ages of 18 and 35.
GSK said the company was “disappointed by the results” and “the fact that the development of this candidate vaccine, which was predominantly aimed at benefiting people in the developing world, is unlikely to be continued now.” A spokesperson for Sanofi Pasteur did not return an email seeking comment
The report says two other major human trials also underway are examining another vaccine approach designed by Janssen Pharmaceuticals, part of the health-care giant Johnson & Johnson. That vaccine was designed as a broad-based approach to HIV, rather than a targeted regimen, according to the primary investigator for one of the two research efforts. That study is testing the vaccine on men who have sex with men and on transgender people in South America and Europe. The other is taking place in five African countries.
[link url="https://www.washingtonpost.com/health/trial-of-promising-hiv-vaccine-fails-in-south-africa/2020/02/02/5f950e3e-4600-11ea-bc78-8a18f7afcee7_story.html"]Full report in The Washington Post[/link]