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Clinical Trials Update
March 24/31, 2020

Leading HIV Vaccine Trial Stopped for Ineffectiveness

JAMA. 2020;323(12):1124. doi:10.1001/jama.2020.2813

The National Institute of Allergy and Infectious Diseases last month halted a highly anticipated clinical trial testing an investigational HIV vaccine regimen. After an interim review, a data and safety monitoring board found that the 2 experimental vaccines in the regimen were ineffective against HIV, although there were no safety concerns.

The phase 2b/3 study, named HVTN 702, or Uhambo, enrolled 5407 HIV-negative volunteers in South Africa who were randomly assigned to the vaccine regimen or to placebo injections. Study participants received 6 injections over 18 months and were offered standard of care for HIV prevention, including access to oral preexposure prophylaxis.

There were 129 HIV infections in the vaccine group and 123 infections in the placebo group after at least 60% of the participants had been in the study for more than 18 months.

The prime-boost vaccine regimen tested in South Africa is based on a regimen tested in the RV144 clinical trial in Thailand—the only vaccine to show protection from HIV.