NIH Launches Trials of Three HIV mRNA Vaccines
NIAID has launched a phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA (mRNA) platform—a technology used in several approved Covid-19 vaccines. The NIAID-funded HIV Vaccine Trials Network (HVTN), based at Fred Hutchinson Cancer Research Center in Seattle, is conducting the trial, called HVTN 302.
“Finding an HIV vaccine has proven to be a daunting scientific challenge,” said NIAID director Dr. Anthony Fauci. “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 instructs the body to make a protein fragment of a target pathogen (such as a virus), which the immune system recognizes and remembers, so it can mount a substantial response if later exposed to that pathogen.
The HVTN 302 study will examine whether three experimental HIV mRNA vaccines are safe and can induce an immune response. Each investigational vaccine candidate is designed to present the spike protein found on the surface of HIV that facilitates entry into human cells. Each of these experimental vaccines encodes for different but highly related, stabilized proteins.
The specific mRNA sequences contained in the vaccines were designed and developed by investigators at the NIAID-funded Scripps Consortium for HIV/AIDS Vaccine Development at Scripps Research Institute and the Bill & Melinda Gates Foundation-funded IAVI Neutralizing Antibody Center at Scripps, in collaboration with scientists at Moderna, Inc.
The HVTN 302 study will enroll up to 108 adults ages 18 to 55 at 11 sites across the country. Each participant will be randomly assigned to 1 of 6 groups each receiving 3 vaccinations over 6 months of 1 of the experimental vaccines.
Safety and immune responses will be examined via blood and lymph node fine-needle aspiration samples taken at specified timepoints throughout the trial. Clinical staff will monitor participant safety throughout the study. The clinical trial is expected to be completed by July 2023.