New clinical trial will test three mRNA vaccine candidates for HIV
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The National Institute of Allergy and Infectious Diseases announced Monday that it has initiated a phase 1 clinical trial of three experimental messenger RNA HIV vaccines.
The study will be conducted by NIAID-funded HIV Vaccine Trials Network (HVTN), which is based at the Fred Hutchinson Cancer Research Center in Seattle.
“Finding an HIV vaccine has proven to be a daunting scientific challenge,” NIAID Director Anthony S. Fauci, MD, said in a press release. “With the success of safe and highly effective COVID-19 vaccines, we have an exciting opportunity to learn whether mRNA technology can achieve similar results against HIV infection.”
An mRNA vaccine works by delivering a piece of genetic material that teaches the immune system to recognize a target pathogen and mount a response, the NIH noted. The technology was used to create the first two licensed COVID-19 vaccines made by Pfizer-BioNTech and Moderna.
The new trial, HVTN 302, will assess whether three experimental HIV vaccines — currently named BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA — are safe and can induce immune responses.
The vaccines are designed to present the spike protein found on the surface of HIV. None can cause HIV infection.
HVTN 302 will be led by Jesse Clark, MD, an HIV researcher at the University of California, Los Angeles, and Sharon Riddler, MD, associate chief of clinical research at the University of Pittsburgh. It will enroll adults aged 18 to 55 years in 11 U.S. cities — Birmingham, Alabama; Boston; Los Angeles; New York; Philadelphia; Pittsburgh; Rochester, New York; and Seattle.
The researchers will randomly assign participants to one of six groups, each receiving three doses of one of the experimental vaccines. The first three groups, each made up of 18 participants, will receive intramuscular injections of 100 µg of their assigned candidate at their first visit and again at 2 months, followed by a third dose at 6 months.
Researchers will evaluate participants 2 weeks after their first dose to ensure that safety criteria are met. If so, the remaining three groups will be vaccinated with 250 µg of the assigned vaccine at the same time intervals.
The trial is expected to be completed by July 2023.
Perspective
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The amazing success of mRNA vaccines in COVID-19 makes it obvious and imperative to apply this technology to other viral infections that have been historic challenges to effective immunization development to date.
Certainly, HIV is high on this list.
The ability to tailor the immunogen so readily with the mRNA approach could allow the improved response we have waited for so long. This will be an interesting process to follow. Clearly, this is an understatement.
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