FREE CLINICAL TRIALS NIH TRIAL

NIAID conducts and supports research-at NIH, throughout the United States, and worldwide-to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these illnesses. More information about the HVTN 302 study is available on using the identifier NCT05217641.

FREE CLINICAL TRIALS NIH TRIAL

The clinical trial is expected to be completed by July 2023.

Clinical staff will closely monitor participant safety throughout the study. Safety and immune responses will be examined via blood and lymph node fine-needle aspiration samples taken at specified timepoints throughout the trial. If so, the remaining three groups of 18 participants each (Group B) will be vaccinated with 250 mcg of the assigned investigational vaccine, followed by injections two and six months after the initial vaccination.

Participants in Group A will be evaluated two weeks after initial vaccination to ensure safety criteria have been met. 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. Each participant will be randomly assigned to one of six groups each receiving three vaccinations of one of the experimental vaccines. Led by principal investigators Jesse Clark, M.D., of the University of California Los Angeles, and Sharon Riddler, M.D., of the University of Pittsburgh, the HVTN 302 study will enroll up to 108 adults ages 18 to 55 years at 11 sites in: Birmingham, Alabama Boston Los Angeles New York City Philadelphia Pittsburgh Rochester, New York and Seattle. Moderna manufactured the investigational vaccines through a NIAID-supported contract. 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. None of the three vaccine candidates can cause HIV infection. Each of the experimental vaccines encodes for different but highly related, stabilized proteins. Each investigational vaccine candidate is designed to present the spike protein found on the surface of HIV that facilitates entry into human cells. 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. вЂњWith 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.вЂќДЄn 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.

вЂњFinding an HIV vaccine has proven to be a daunting scientific challenge,вЂќ said Anthony S. 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 National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, 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. Scanning electron micrograph of an HIV-infected H9 T cell.

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