Pursuing Universality: NIH Initiates Clinical Trials for the Ultimate Influenza Vaccine

FluMos-v2, the promising universal influenza vaccine candidate, has initiated its Phase 1 clinical trial at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), this trial aims to assess the vaccine’s safety and its capacity to stimulate an immune response.

Unlike conventional influenza vaccines, which target specific strains, FluMos-v2 aspires to provide broader protection by targeting six different influenza strains. This groundbreaking research takes us closer to the goal of developing a universal influenza vaccine capable of safeguarding against multiple strains with less frequent administration, according to Acting NIAID Director Hugh Auchincloss, M.D.

FluMos-v2 is the brainchild of scientists at NIAID’s Vaccine Research Center (VRC) and is an evolution of its predecessor, FluMos-v1, which commenced human testing in 2021 and is still under evaluation. FluMos-v2 achieves its multi-strain coverage by presenting segments of the influenza virus hemagglutinin (HA) protein in repetitive patterns on self-assembling nanoparticle scaffolds. Exposure to these harmless viral protein fragments primes the immune system to recognize and combat the actual virus. In animal testing, this experimental vaccine has demonstrated robust antibody responses.

While FluMos-v1 displayed HA from four influenza virus strains, FluMos-v2 goes even further by incorporating HA from six strains: four influenza A viruses and two influenza B viruses. This expansion is expected to enhance the vaccine’s effectiveness by offering protection against a broader spectrum of influenza viruses.

The Phase 1 clinical trial will enroll 24 healthy volunteers aged 18-50, who will receive two intramuscular injections of FluMos-v2 spaced 16 weeks apart. Initially, participants will be enrolled in the lower dose group (60 mcg per vaccination). Subsequently, if no safety concerns arise after a minimum of three participants have received this dose, enrollment will commence in the higher dose group (180 mcg per vaccination). The study intends to include 12 participants in each dosage group.

Throughout the 40-week period following their initial vaccination, participants will undergo regular follow-up via phone calls and examinations to monitor their responses to the experimental vaccine. Blood samples will be collected during study visits to assess immune responses to the vaccine candidate.

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