Enrollment in a Part 1 trial of a brand new investigational common influenza vaccine candidate has begun on the Nationwide Institutes of Well being’s Medical Heart in Bethesda, Maryland. The trial is sponsored by the Nationwide Institute of Allergy and Infectious Illnesses (NIAID), a part of the NIH, and can consider the investigational vaccine for security and its capacity to elicit an immune response.
Presently accessible seasonal influenza (or “flu”) vaccines are efficient at stopping particular strains of influenza. Every year, the vaccines are re-evaluated and altered to finest match the strains of flu predicted to be essentially the most dominant within the upcoming flu season. Most seasonal flu vaccines are designed to coach the immune system to defend in opposition to three or 4 completely different frequent strains of flu, however a “common” influenza vaccine would possibly sometime present safety in opposition to many extra.
An excellent common influenza vaccine may very well be taken much less incessantly than annually and defend in opposition to a number of strains of influenza virus. With every new common influenza vaccine candidate and medical trial, we take one other step nearer to that objective.”
Hugh Auchincloss, M.D., Appearing NIAID Director
The vaccine candidate beneath investigation, FluMos-v2, was designed by researchers at NIAID’s Vaccine Analysis Heart (VRC). It’s an adaptation of an earlier common flu vaccine candidate, FluMos-v1, which started first-in-human testing in 2021 and remains to be present process trials. FluMos-v2 is designed to induce antibodies in opposition to many various influenza virus strains by displaying a part of the influenza virus hemagglutinin (HA) protein in repeating patterns on self-assembling nanoparticle scaffolds. Publicity to those innocent fragments of virus proteins prepares the immune system to acknowledge and struggle the precise virus. When examined in animals, the experimental vaccine resulted in strong antibody responses.
Whereas the FluMos-v1 vaccine candidate shows HA from 4 strains of influenza virus, FluMos-v2 shows HA from six: 4 influenza A viruses and two influenza B viruses. The researchers anticipate that it will additional broaden vaccine recipients’ immunity, offering safety in opposition to a greater diversity of influenza viruses.
The brand new medical trial is anticipated to enroll 24 wholesome volunteers, aged 18-50 years, who will obtain two intramuscular injections of the FluMos-v2 vaccine candidate. These injections will likely be given 16 weeks aside. At first, contributors will likely be enrolled within the decrease dose group (60 mcg per vaccination). If no security issues are recognized after at the least three contributors have obtained this dose, enrollment will start within the increased dose (180 mcg per vaccination) group. The research crew plans to enroll 12 contributors into every dosage group.
For 40 weeks after their first vaccination, contributors will obtain common follow-up cellphone calls and examinations to trace their responses to the experimental vaccine. Blood samples will likely be taken throughout research visits to measure any immune responses to the vaccine candidate.
NIH/Nationwide Institute of Allergy and Infectious Illnesses