NIH Launches the First In-Human Universal Flu Vaccine Trial

Phase 1 trial of a novel universal influenza vaccine candidate, FluMos-v2 has begun at the National Institutes of Health’s (NIH) Clinical Center in Bethesda, Maryland. Its purpose is to broaden vaccine recipients’ immunity compared to previous vaccine candidates, providing protection against a larger range of influenza viruses (1^✔ ✔Trusted Source
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults

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Universal Flu Vaccine - Is It a One-Stop Solution against All Viruses?

Currently, available seasonal influenza (or “flu”) vaccines are effective at preventing specific strains of influenza. Each year, the vaccines are re-evaluated and changed to best match the strains of flu predicted to be the most dominant in the upcoming flu season. Most seasonal flu vaccines are designed to train the immune system to defend against three or four different common strains of flu, but a “universal” influenza vaccine might someday provide protection against many more.

The vaccine candidate under investigation, FluMos-v2, was designed by researchers at NIAID’s Vaccine Research Center (VRC). It is an adaptation of an earlier universal flu vaccine candidate, FluMos-v1, which began first-in-human testing in 2021 and is still undergoing trials.

Safety and Efficacy of Flu Vaccines in Animal Trials

FluMos-v2 is designed to induce antibodies against many different influenza virus strains by displaying part of the influenza virus hemagglutinin (HA) protein in repeating patterns on self-assembling nanoparticle scaffolds. Exposure to these harmless fragments of virus proteins prepares the immune system to recognize and fight the actual virus. When tested in animals, the experimental vaccine resulted in robust antibody responses.

While the FluMos-v1 vaccine candidate displays HA from four strains of influenza virus, FluMos-v2 displays HA from six: four influenza A viruses and two influenza B viruses. The researchers anticipate that this will further broaden vaccine recipients’ immunity, providing protection against a wider variety of influenza viruses.

The new clinical trial is expected to enroll 24 healthy volunteers, aged 18-50 years, who will receive two intramuscular injections of the FluMos-v2 vaccine candidate. These injections will be given 16 weeks apart.

At first, participants will be enrolled in the lower dose group (60 mcg per vaccination). If no safety concerns are identified after at least three participants have received this dose, enrollment will begin in the higher dose (180 mcg per vaccination) group. The study team plans to enroll 12 participants in each dosage group.

For 40 weeks after their first vaccination, participants will receive regular follow-up phone calls and examinations to track their responses to the experimental vaccine. Blood samples will be taken during study visits to measure any immune responses to the vaccine candidate.

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Reference:

1. Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults - (https://www.clinicaltrials.gov/study/NCT05968989)

Source: Eurekalert