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Phase 2 trial of universal flu vaccine begins in US
The NIH recently announced the launch of a phase 2 clinical trial examining the safety and efficacy of a universal influenza vaccine, M-001, among healthy volunteers in the United States.
Previously, M-001 (BiondVax Pharmaceuticals) showed promise against a broad range of influenza strains during six clinical trials involving nearly 700 participants in Israel and Europe, according to an NIH press release. For the new trial, led by Robert L. Atmar, MD, of Baylor College of Medicine, and sponsored by the National Institute of Allergy and Infectious Diseases, researchers will further assess the vaccine in 120 adults at four U.S. sites.
M-001 is comprised of three repetitions of nine conserved linear epitopes that are common to most influenza virus strains, including influenza A and B, Atmar told Infectious Disease News. The NIH said the vaccine could potentially protect against current and emerging influenza strains.
“The 2017-2018 influenza season in the United States was among the worst of the last decade and serves as a reminder of the urgent need for a more effective and broadly protective influenza vaccine,” NIAID Director Anthony S. Fauci, MD, said in the release. “An effective universal influenza vaccine would lessen the public health burden of influenza, alleviate suffering and save lives. There are numerous paths of inquiry that the scientific community is pursuing, with each new study yielding more critical information and bringing us closer to our shared goal.”
Atmar and colleagues will randomly assign the participants to receive either two doses of M-001 or placebo during a baseline visit and 22 days later. After approximately 172 days, the participants will then receive an approved seasonal vaccine so that researchers can evaluate M-001’s ability to generate immune responses on its own and when combined with a standard vaccine.
“One of the questions being addressed in this study is how long the responses persist, at least in terms of a single season,” Atmar said.
The participants will be followed for about 7 months, according to Atmar. Results are expected to be released by next fall.
In March, BiondVax announced plans for a phase 3 trial of M-001 that will begin later this year. The trial will enroll 9,630 participants aged older than 50 years in eastern Europe.
“As far as we know, this is the world’s most clinically advanced universal flu vaccine,” Tamar Ben-Yedidia, PhD, chief science officer at BiondVax, said in a press release. “I hope our vaccine will contribute to significant reduction of the economic and social burden of influenza.” – by Stephanie Viguers
Disclosures: Atmar and Fauci report no relevant financial disclosures. Ben-Yedidia is an employee of BiondVax.