Therapy Areas: Vaccines
BiondVax signs universal flu vaccine clinical trial agreement in the US with NIH
21 November 2017 -

Biopharmaceutical company BiondVax Pharmaceuticals Ltd (NASDAQ:BVXV) (TASE: BVXV) on Monday announced that it plans to start a Phase 2 clinical trial in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH).

This flu vaccine study is called "A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity, and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Trivalent Influenza Vaccine."

The company said the trial is designed to evaluate the cell mediated immunity directly induced by its universal flu vaccine candidate M-001, as well as M-001's priming effect to enhance the immunogenicity of current seasonal influenza vaccines.

In conjunction, the company's NIAID-funded trial will include 120 young adults (aged 18 to 45 years) randomly assigned to one of two groups receiving either placebo or M-001. Later, all participants will receive a currently marketed unadjuvanted trivalent seasonal influenza vaccine.

Additionally, the company's four trial sites from the NIAID-supported Vaccine and Treatment Evaluation Units contracts include Baylor College of Medicine in Texas, Cincinnati Children's Hospital Medical Center in Ohio, and the University of Iowa, with laboratory support provided by St. Louis University in Missouri.

Concurrently, the NIAID is submitting the company's Investigational New Drug (IND) to the US Food and Drug Administration (FDA) and participant recruitment is anticipated to begin after the end of the 2017/18 flu season.

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