Clinical trial begins on a new universal flu vaccine candidate
September 19, 2023. 9:43 am
The Elizabeth Deatrick National Institute of Allergy and Infectious Diseases has reported that the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland (USA), has begun enrollment in a Phase 1 trial of a new vaccine candidate universal against…
The Elizabeth Deatrick National Institute of Allergy and Infectious Diseases has reported that, the Clinical Center of the National Institutes of Health (NIH) in Bethesda, Maryland (USA), has begun enrollment in a Phase 1 trial of a new investigational universal flu vaccine candidate, targeting six strains of the virus. The trial, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), will evaluate the safety of the investigational vaccine and its ability to provoke an immune response. The new clinical trial is expected to enroll 24 healthy volunteers, ages 18 to 50, who will receive two intramuscular injections of the FluMos-v2 vaccine candidate. These injections will be given 16 weeks apart. Initially, participants will be enrolled in the lowest dose group (60 mcg per vaccine). If no safety concerns are identified after at least three participants have received this dose, enrollment will begin in the highest dose group (180 mcg per vaccine). The study team plans to enroll 12 participants in each dosing group.
Study design
For 40 weeks after their first vaccination, participants will receive follow-up phone calls and periodic exams to track their responses to the experimental vaccine. Blood samples will be taken during study visits to measure any immune response to vaccine candidate. This is the second vaccine under investigation, the first was against four strains of the virus, FluMos-v1. Now the candidate vaccine under investigation, esuMos-v2, was designed by researchers at the NIAID Vaccine Research Center (VRC), after adapting the previous one. FluMos-v1 first began testing in humans in 2021 and is still in trials. FluMos-v2 is designed to induce antibodies against many different strains of the influenza virus by showing some of the Influenza virus hemagglutinin (HA) protein in repeating patterns on self-assembled nanoparticle structures. ‘Exposure to these harmless fragments of viral proteins prepares the immune system to recognize and fight the real virus. When tested in animals, the experimental vaccine produced strong antibody responses,’ the research notes. While the vaccine candidate FluMos-v1 shows HA from four influenza virus strains, FluMos-v2 shows HA from six: four influenza A viruses and two influenza B viruses. The researchers anticipate that this will further extend the immunity of vaccine recipients, providing protection against a wider variety of influenza viruses.
Why is a universal vaccine sought?
Currently available seasonal influenza (or ‘flu’) vaccines are effective at preventing specific strains of influenza. Every year, vaccines are reevaluated and changed to better match the flu strains expected to be most dominant in the next flu season. Most seasonal flu vaccines are designed to train the immune system to defend against three or four different common flu strains, but a ‘universal’ flu vaccine could one day provide protection against many more. ‘An ideal universal influenza vaccine could be given less frequently than once a year and protect against multiple strains of the influenza virus. With each new universal influenza vaccine candidate and clinical trial, we take another step toward that goal,’ said NIAID Acting Director Hugh Auchincloss, MD.
2023-09-19 07:43:00
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