Researchers at the National Institutes of Health (NIH) have launched a phase 1 clinical trial assessing the potential of a universal flu vaccine candidate in humans. Named FluMos-v1, the investigative nanoparticle influenza vaccine was developed to provide lasting protection against various different strains of influenza (the virus that causes the common flu).
The latest FluMos-v1 candidate has outperformed standard influenza vaccines in pre-clinical animal studies and shown promise as a candidate to move into human clinical trials.
Normally, standard influenza vaccines need to be reformulated on a yearly basis to stay up to date with emerging strains. The HA protein region of the virus is a common focus area, with vaccines being adapted to target this changing protein in influenza strains that are predicted to become dominant in the coming flu season.
If the standard influenza vaccine is not well-matched to target the ever-changing HA protein, it results in a reduction in antibody production for that given virus strain and reduces the overall immune protection provided. Therefore, a universal flu vaccine that could elicit a strong and lasting antibody response to a broader range of influenza strains has been highly sought after. In the recently launched trial, FluMos-v1 will target the HA proteins of 4 different strains of influenza.
“The health and economic burdens of influenza are substantial, and the world badly needs improved flu vaccines,” said NIAID Director Anthony Fauci in a statement. “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 trial is taking place at the NIH's Clinical Center in Bethesda, Maryland, and is busy recruiting healthy participants between the ages of 18 and 50. The study is looking to enroll a total of 40 participants, split into three groups. Group one will receive 20-micrograms (mcg) of FluMos-v1, while Group two will receive a standard seasonal flu vaccine, representing the control group. If FluMos-v1 at the 20mcg dose is found to be well tolerated and safe, a third group will receive 60mcg of the FluMos-v1 investigative vaccine and the outcomes for all three groups will be compared.
All the participants will self-report using a diary the week following their inoculation and report any adverse reactions or health concerns. They will also be taking a record of their temperature daily and report the amount of swelling and redness around the injection site.
The participants will then return after 40 weeks (one full flu season) to the NIH in Bethesda, Maryland, to have further tests done. Blood tests will be taken to look for any long-term abnormalities. They will also assess the number of antibodies produced against the HA protein of the virus strains following the vaccination to see how well the investigative vaccine had worked. For those that received FluMos-v1, samples of their oral mucosa will also be taken to assess the localized immune response to the vaccine.
The phase 1 trial has an estimated completion date of May 1, 2023, after which the results will reveal whether the candidate FluMos-v1 could be moved into a larger phase 2 trial if safety and dosage criteria are met.
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