The National Institute of Allergy and Infectious Diseases (NIAID) has launched Phase 1 clinical trial to evaluate experimental HIV vaccines.
New Phase 1 clinical trial evaluates three experimental HIV vaccines based on a messenger RNA (mRNA) platform. NIAID is sponsoring the study, called HVTN 302, and the NIAID-funded HIV Vaccine Trials Network (HVTN), based at Fred Hutchinson Cancer Research Center in Seattle, is conducting the trial.
‘The HVTN 302 study examines if the three experimental HIV mRNA vaccines are safe and can induce an immune response.’
Read More..
“Finding an HIV vaccine has proven to be a daunting scientific challenge,” said Anthony S. Fauci, M.D. NIAID director. “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.” Read More..
An mRNA vaccine works by delivering a piece of genetic material that instructs the body to make a protein fragment of a target pathogen like 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 the following three experimental 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 MD39.3 gp151 CD4KO mRNA.
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 the experimental vaccines encodes for different but highly related, stabilized proteins. None of the three vaccine candidates can cause HIV infection.
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 (CHAVD) at the Scripps Research Institute and the Bill & Melinda Gates Foundation-funded IAVI Neutralizing Antibody Center at Scripps, in collaboration with scientists at Cambridge, Massachusetts-based Moderna, Inc. Moderna manufactured the investigational vaccines through an NIAID-supported contract.
Advertisement
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 of their assigned vaccine candidate at the initial visit, at month two, and again at month six.
Advertisement
Safety and immune responses will be examined via blood and lymph node fine-needle aspiration samples taken at specified 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.
Source-Medindia