Kampala, Uganda | URN | The National Institute of Health has stopped administration of vaccinations in its HVTN 702 clinical trial of an investigational HIV vaccine.
This is after an independent Data and Safety Monitoring Board (DSMB) found during a review that the regimen did not prevent HIV.
The study, named HVTN 702 or Uhambo, began in 2016 and has been taking place in South Africa. It was testing an investigational vaccine regimen based on the only vaccine regimen ever to show protection against the virus that was initially conducted in Thailand.
“An HIV vaccine is essential to end the global pandemic, and we hoped this vaccine candidate would work. Regrettably, it does not,” said the institute Director Anthony S. Fauci in a statement released on Monday evening. “Research continues on other approaches to a safe and effective HIV vaccine, which I still believe can be achieved,” he said.
The HVTN 702 study enrolled 5,407 HIV-negative volunteers at 14 sites across South Africa.
The study population consisted of sexually active men and women aged 18 to 35 years. The study volunteers were randomly assigned to receive either the investigational vaccine regimen or placebo injections. Study participants received six injections over 18 months. During the analysis, the DSMB examined data from 2,694 volunteers who received the investigational vaccine regimen and 2,689 volunteers who received the placebo injection.
The analysis looked at how many participants were diagnosed with HIV after at least 60 per ent of the participants had been in the study for more than 18 months – enough time for the vaccine regimen to stimulate an immune response. In this analysis, 129 HIV infections occurred among the vaccine recipients, and 123 HIV infections occurred among the placebo recipients. Based on these findings, the DSMB concluded that the investigational vaccines had not shown any efficacy.
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The report noted that there was no significant evidence of either decreased or increased infection rates with vaccination. “The people of South Africa have made history by answering this important scientific question. Sadly, we wish the answer was different,” said study Chair Glenda Gray. She noted however that no safety concerns were noted among those that were using the vaccine during the study period.
However while this study was being done in South Africa, it had given hope of ending the virus to the world as it not only targeted the virus circulating in South Africa one of the highest burdened countries but according to scientists the hope was that the vaccine can handle virus types circulating in other countries effectively.