A first phase 1 trial in humans evaluating the safety and immunogenicity of a researched nanoparticle flu vaccine designed to provide lasting protection against multiple strains of influenza virus has begun at the Bethesda National Institutes of Health Clinical Center , Maryland. Healthy participants aged 18 to 50 years will receive a licensed seasonal flu vaccine or experimental vaccine, FluMos-v1. Scientists at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) developed FluMos-v1 to stimulate antibodies against multiple strains of influenza virus showing part of the influenza virus hemagglutinin (HA) protein in self-assembling nanoparticle scaffolds. Alicia T. Widge, MD, of the NIAID Vaccine Research Center (VRC), is the lead researcher on the NIAID-sponsored single trial.
“The economic and health burdens of grip they are substantial and the world needs to greatly improve flu vaccines, “said NIAID Director Anthony S. Fauci, MD.” I am encouraged by the great promise of the VRC nanoparticle vaccine candidate, who has so far performed very well in preclinical trials. “
Standard influenza vaccines should be reformulated and administered annually to match changes in HA protein in the virus. strains it is expected to dominate the next flu season. If the vaccine does not adapt well to the dominant circulating virus strains, el antibodies caused can provide suboptimal protection. Many research groups are developing and testing so-called universal flu vaccines, and one day they could eliminate the need to get vaccinated annually by generating long-term vaccines. antibodies to protect against many existing or emerging strains of influenza virus, including those not represented in the vaccine.
Similar to commercially available influenza vaccines, the FluMos-v1 nanoparticle experimental vaccine is designed to cause antibodies to the HA protein of four different virus strains, two influenza A strains of H1 and H3 subtypes, and two influenza B strains. However, unlike conventional influenza vaccines, FluMos-v1 shows multiple copies of each of the four types of HA. The 20 HA epitopes distributed in repetitive patterns on the nanoparticle scaffolds sent a strong signal to the immune system and elicited a solid antibody response in animal models.
In their recent animal study, VRC scientists led by Barney S. Graham, MD, Ph.D., and Masaru Kanekiyo, DVM, Ph.D., and their University of Washington collaborators tested the nanoparticle vaccine in mice, ferrets, and monkeys, and compared the immune responses generated with those produced by a commercially available seasonal influenza vaccine. FluMos-v1 performed as well or slightly better than the commercial vaccine in eliciting antibodies that matched the HA components of the vaccine. FluMos-v1 greatly outperformed the season flu vaccine in its ability to cause protective antibodies against two grip type A subtypes (H5 and H7) not listed in the vaccine.
The clinical trial aims to enroll 35 participants, 15 of whom will receive a single intramuscular injection of an FDA-licensed quadrivalent season flu vaccine. Five participants will receive a 20 microgram (mcg) dose of the research vaccine by intramuscular injection. If no safety issues are detected at this dose, an additional 15 volunteers will receive a 60 mcg dose of the research vaccine.
Participants will keep a diary for one week after vaccination to report any signs or symptoms, including redness, pain, or swelling at the injection site, fatigue, headache, muscle aches, or joint pain. All volunteers will record their temperature daily and measure any swelling or redness at the injection site. Volunteers will return to the NIH clinic periodically for 40 weeks (during a flu season) after inoculation and will provide blood samples. He blood samples will provide information on the safety of the research vaccine and will also be evaluated to determine the levels of antibodies directed against HA produced after vaccination. Participants receiving FluMos-v1 will be given oral mucosal samples that will be used for research purposes to determine the immune response of the oral mucosa to the vaccine.
Seyhan Boyoglu-Barnum et al, nanoparticle vaccines against quadrivalent influenza induce broad protection, Nature (2021). DOI: 10.1038 / s41586-021-03365-x
Citation: NIH Launches Clinical Trial of a Universal Influenza Vaccine Candidate (2021, June 2) Retrieved June 2, 2021 from https://medicalxpress.com/news/2021-06-nih-clinical- trial-universal-influenza.html
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