The Phase 1 study is among the first to examine mRNA technology for HIV.
“Finding an HIV vaccine has proven to be a daunting scientific challenge,” said Anthony S. Fauci, director of MD NIAID. “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 that it can trigger a substantial response if subsequently exposed to this pathogen. The HVTN 302 study will examine whether the following three candidate HIV mRNA vaccines are safe and can induce an immune response: 1) BG505 MD39.3 mRNA, 2) BG505 MD39.3 gp151 mRNA, and 3) BG505 MD39 mRNA .3 gp151 CD4KO . Each experimental vaccine candidate is designed to feature the spike protein found on the surface of HIV that facilitates entry into human cells. Each of the experimental vaccines encodes different but highly related stabilized proteins. None of the three candidate vaccines can cause HIV infection.
The specific mRNA sequences contained in the vaccines were designed and developed by researchers from the NIAID-funded Scripps Consortium for HIV/AIDS Vaccine Development (CHAVD) at the Scripps Research Institute and the Bill & Melinda Gates to Scripps. , in collaboration with scientists from Moderna, Inc., based in Cambridge, Massachusetts. Moderna manufactured the experimental vaccines under a contract supported by NIAID.
Led by lead researchers Jesse Clark, MD, of the University of California, Los Angeles, and Sharon Riddler, MD, of the University of Pittsburgh, the HVTN 302 study will enroll up to 108 adults between the ages of 18 and 55. at 11 locations in: Birmingham, Alabama; Boston; Los Angeles; New York City; Philadelphia Cream; Pittsburgh; Rochester, New York and Seattle. Each participant will be randomly assigned to one of six groups each receiving three vaccinations of one of the experimental vaccines. The first three groups (18 participants each), called group A, will receive intramuscular injections of 100 micrograms (mcg) of their assigned vaccine candidate at the initial visit, at month two and again at month six. Group A participants will be assessed two weeks after the initial vaccination to ensure that safety criteria have been met. If so, the remaining three groups of 18 participants each (Group B) will be vaccinated with 250 mcg of the assigned experimental vaccine, followed by injections two and six months after the initial vaccination.
Safety and immune responses will be examined via blood and lymph node samples collected by fine needle aspiration at specific time points throughout the trial. Clinical staff will closely monitor participant safety throughout the study. The clinical trial is expected to be completed by July 2023.
More information about the HVTN 302 study is available on ClinicalTrials.gov using the identifier NCT05217641.
NIAID conducts and supports research—at the NIH, in the United States, and around the world—to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets, and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): The NIH, the country’s medical research agency, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.