WASHINGTON (dpa-AFX) - Hopes of a new potential HIV vaccine faded as researchers at the National Institutes of Health have halted a research trial after finding that the treatment was not effective.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, stopped administration of vaccinations in its HVTN 702 clinical trial of an investigational HIV vaccine.
NUH said an independent data and safety monitoring board (DSMB) of NIAID found during an interim review that the regimen did not prevent HIV among more than 5,000 people in South Africa, who were subjected to the trial. However, there is no concern regarding the patients' safety.
'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 Anthony S. Fauci, M.D. He added that research continues on other approaches to a safe and effective HIV vaccine, which he believes can be achieved.
The study enrolling 5,407 HIV-negative sexually active men and women aged 18 to 35 years began in 2016 at 14 sites across South Africa. They were randomly assigned to administer either the investigational vaccine regimen or placebo injections.
In the interim analysis conducted on January 23, it was found that 129 HIV infections occurred among the vaccine recipients, and 123 HIV infections occurred among the placebo recipients.
Based on this, the DSMB concluded that the investigational vaccines had not shown any efficacy. The DSMB recommended that no further vaccinations be administered and that participants remain in the study for follow-up. The report noted there was no significant evidence of either decreased or increased infection rates with vaccination.
Dr. Glenda Gray, who is president and chief executive officer of the South African Medical Research Council, said efforts to explore promising avenues for preventing HIV with other vaccines and tools, both in South Africa and around the world, will continue.
NIH is investing in multiple approaches to prevent HIV with the aim of delivering new options that are safe, effective, desirable to diverse populations, and scalable worldwide to help end the global pandemic. These efforts include two other late-stage, multinational vaccine trials - Imbokodo and Mosaico, both testing a novel mosaic vaccine regimen.
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