The government agency will be assessing the safety and immunogenicity of an investigational nanoparticle influenza vaccine.
The National Institutes of Health (NIH) announced this week it had begun a phase 1 human trial studying a universal influenza vaccine, FluMos-v1. The vaccine was developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and is designed to stimulate antibodies against multiple influenza virus strains by displaying part of the influenza virus hemagglutinin (HA) protein on self-assembling nanoparticle scaffolds.
Alicia T. Widge, MD, of NIAID’s the Vaccine Research Center (VRC), is the principal investigator of the NIAID-sponsored single-site trial.
“The health and economic burdens of influenza are substantial, and the world badly needs improved flu vaccines,” NIAID Director Anthony S. Fauci, MD, said. “I am encouraged by the great promise of the VRC nanoparticle vaccine candidate, which so far has performed very well in pre-clinical testing.”
The experimental nanoparticle FluMos-v1 vaccine is designed to elicit antibodies directed against the HA protein from four different virus strains, 2 influenza type A strains of H1 and H3 subtype and 2 influenza type B strains—which is similar to other commercially available vaccines. Where the investigational flu vaccine differs is that it displays multiple copies of each of the four HA types. The 20 HA epitopes arrayed in repeating patterns on the nanoparticle scaffolds sent a strong signal to the immune system and prompted a robust antibody response in animal models.
The clinical trial aims to enroll 35 participants, 15 of whom will receive a single intramuscular injection of an FDA-licensed, quadrivalent seasonal flu vaccine. Five participants will receive one 20-microgram (mcg) dose of the investigational vaccine by intramuscular injection. If there are no safety concerns detected at that dosage, an additional 15 volunteers will receive one 60-mcg dose of the investigational vaccine.
Other researchers are looking at potential influenza vaccines. For example, Cincinnati, Ohio-based Blue Water Vaccines is also working on developing a universal vaccine that will permanently protect against current and future influenza strains. Contagion interviewed Blue Water CEO Joseph Hernandez late last year about their investigational vaccine.