Scanning electron micrograph of an HIV-infected H9 T cell. Credit: NIAID
Phase 1 Study Is Among First to Examine mRNA Technology for HIV.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched a Phase 1 medical trial assessing three speculative HIV vaccines based upon a messenger RNA (mRNA) platform– an innovation used in numerous authorized COVID-19 vaccines. 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.
” Finding an HIV vaccine has shown to be a difficult scientific challenge,” said Anthony S. Fauci, M.D. NIAID director. “With the success of safe and extremely effective COVID-19 vaccines, we have an amazing opportunity to learn whether mRNA innovation can accomplish similar results against HIV infection.”
An mRNA vaccine works by delivering a piece of hereditary product that advises the body to make a protein piece of a target pathogen (such as an infection), which the immune system recognizes and remembers, so it can mount a considerable action if later exposed to that pathogen. The HVTN 302 study will analyze whether the following three experimental HIV mRNA vaccines are safe and can cause an immune reaction: 1) BG505 MD39.3 mRNA, 2) BG505 MD39.3 gp151 mRNA, and 3) BG505 MD39.3 gp151 CD4KO mRNA.
The specific mRNA series contained in the vaccines were created and established by detectives 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 partnership with scientists at Cambridge, Massachusetts-based Moderna, Inc. Moderna manufactured the investigational vaccines through a NIAID-supported agreement.
Led by principal private 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 research study will enlist up to 108 adults ages 18 to 55 years at 11 websites in: Birmingham, Alabama; Boston; Los Angeles; New York City; Philadelphia; Pittsburgh; Rochester, New York and Seattle. Each individual will be randomly appointed to among six groups each getting 3 vaccinations of one of the experimental vaccines. The very first 3 groups (18 individuals each), called Group A, will get intramuscular injections of 100 micrograms (mcg) of their appointed vaccine candidate at the preliminary check out, at month 2 and once again at month 6. Participants in Group A will be examined two weeks after initial vaccination to ensure safety requirements have been fulfilled. If so, the staying 3 groups of 18 individuals each (Group B) will be vaccinated with 250 mcg of the appointed investigational vaccine, followed by injections 2 and six months after the preliminary vaccination.
Safety and immune actions will be examined by means of blood and lymph node fine-needle goal samples taken at defined timepoints throughout the trial. Clinical personnel will carefully keep an eye on individual security throughout the study. The scientific trial is expected to be finished by July 2023.
More details about the HVTN 302 research study is offered on ClinicalTrials.gov utilizing the identifier NCT05217641.
An mRNA vaccine works by providing a piece of hereditary material that instructs the body to make a protein fragment of a target pathogen (such as a virus), which the immune system remembers and recognizes, so it can mount a significant action if later exposed to that pathogen. The HVTN 302 study will take a look at whether the following 3 experimental HIV mRNA vaccines are safe and can cause 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 developed to provide the spike protein discovered on the surface area of HIV that helps with entry into human cells. None of the three vaccine prospects can cause HIV infection.