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Phase 2 ‘universal flu vaccine’ trial announced


The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced on May 4 that is sponsoring a phase 2 trial of a universal flu vaccine, M-001. The trial will test the experimental vaccine for safety and its ability to produce potentially broad protective immune responses, both on its own and when followed by a standard seasonal influenza vaccine. It is being conducted at four U.S. sites that are part of the Vaccine and Treatment Evaluation Units, funded by NIAID.

Vaccine syringe luiscar/Thinkstock
The trial, led by Robert L. Atmar, MD, of Baylor College of Medicine, Houston, will test the M-001 vaccine, developed and produced by Israel’s BiondVax Pharmaceuticals. The vaccine contains antigenic peptide sequences shared among many influenza viruses, potentially allowing it to protect against multiple current and emerging strains of influenza. BiondVax previously conducted six clinical trials in Israel and Europe involving a total of 698 participants, which indicated that the vaccine candidate was safe and well tolerated, and produced an immune response to a broad range of influenza strains, according to the NIAID press release.

“An effective universal influenza vaccine would lessen the public health burden of influenza, alleviate suffering, and save lives,” said NIAID Director Anthony S. Fauci, MD. Such a vaccine would help eliminate the problem of unanticipated seasonal variation in the flu virus mix, which can make the chosen vaccine combination for that season less effective.

The study is a randomized, double-blind, placebo-controlled trial that will enroll 120 men and nonpregnant women, aged 18-49 years, inclusive, and is designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of M-001 followed by a seasonal quadrivalent inactivated influenza vaccine.

The primary objectives are to assess the safety as measured by vaccine-related adverse events, reactogenicity, and laboratory adverse events; and to assess the T-cell responses to M-001 component peptides.

More information about the study can be found at, using the identifier NCT03058692.

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