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Trial Underway Testing Universal Flu Vaccine

Influenza virus

3-D representation of generic influenza virus (CDC.gov)

4 May 2018. A clinical trial is recruiting participants to test a vaccine to protect against a variety of influenza strains, instead of today’s vaccines designed to prevent infections from specific strains expected in a given year. The study, funded by National Institute of Allergy and Infectious Diseases, or NIAID, is evaluating the experimental vaccine code-named M-001 by BiondVax Pharmaceuticals in Ness Ziona, Israel.

The virus causing flu outbreaks has two main types known as influenza A and B. Influenza A viruses emerge as different strains from the composition of proteins on their surface, called hemagglutinin and neuraminidase, abbreviated to H and N. The various influenza A strains are made up of combinations of 18 H and 11 N proteins. The continuous mutation of flu viruses, particularly influenza A, make the disease difficult to contain from year to year.

Different flu strains emerge each annual flu season, and public health authorities need to prepare well in advance to anticipate the strains likely to arrive, then develop, produce, and distribute seasonal vaccines to protect against those strains. If the annual predictions miss the correct mix of influenza strains, the seasonal flu vaccines are less effective. According to Centers for Disease Control and Prevention, influenza results in as many as 710,000 hospitalizations and 56,000 deaths each year in the U.S.

BiondVax says its technology produces synthetic peptides, or short amino acid chains similar to proteins, that generate specific immune responses. These peptides are designed to resemble epitopes, the binding locations on the surface of larger antigen proteins recognized and targeted by antibodies. In the case of M-001, the peptides have special properties the company calls “conserved epitopes,” that are common to most known flu strains and can withstand seasonal variations in other parts of the virus protein. M-001 has already been tested in 6 early- and intermediate-stage clinical trials, mainly in Israel but the latest was in Europe in 2016.

The new intermediate-stage trial is testing M-001’s ability to safely generate a broad immune response among 120 male and female adults. Participants will be randomly assigned to receive 2 doses of M-001 or a placebo about 3 weeks apart. Then, nearly 6 months later, all participants will receive the standard seasonal flu vaccine designed to prevent infection from the 4 anticipated strains for that year. Participants will be tracked for 7 months, and provide periodic blood samples, which will be analyzed for the presence of immune-system cells with flu-protecting properties. Individuals in the trial will also be monitored for any adverse effects during that period.

“The 2017-2018 influenza season in the United States was among the worst of the last decade,” says NIAID director Anthony Fauci in a statement, “and serves as a reminder of the urgent need for a more effective and broadly protective influenza vaccine. An effective universal influenza vaccine would lessen the public health burden of influenza, alleviate suffering, and save lives.”

The study is led by Robert Atmar, professor of infectious diseases at Baylor College of Medicine in Houston, also one of the trial sites. In addition to Baylor, participants are being recruited at University of Iowa in Iowa City and Cincinnati Children’s Hospital Medical Center in Ohio. BiondVax is already planning a late-stage clinical trial of M-001 as a stand-alone universal flu vaccine.

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