BiondVax announced the signing of the clinical trial agreement (CTA) for a Phase 2 clinical trial with the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH).
The study is titled "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." It is designed to evaluate the cell mediated immunity directly induced by BiondVax's universal flu vaccine candidate M-001, as well as M-001's priming effect to enhance the immunogenicity of current seasonal influenza vaccines.
"We are honored to work with the American NIH in their effort to improve protection from the flu, one of the world's most common infectious diseases,” Dr. Ron Babecoff, BiondVax's CEO, said. “We hope that this important strategic collaboration will lead to additional partnerships with other leading institutions."
The 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. Four trial sites from the NIAID-supported Vaccine and Treatment Evaluation Units contracts are participating, namely 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. The NIAID is submitting the Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA), and participant recruitment is anticipated to begin after the end of the 2017/18 flu season.