BiondVax Pharmaceuticals Ltd. has 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 US 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.
Dr. Ron Babecoff, BiondVax’s chief executive officer, commented, “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. We hope that this important strategic collaboration will lead to additional partnerships with other leading institutions.”
BiondVax’s chief science officer Dr. Tamar Ben-Yedidia explained, “Along with our successful European Union phase 2b clinical trial results, this current study will further explore the science behind M-001, our innovative universal flu vaccine candidate. As part of the protocol team, it has been an exciting experience working alongside the field’s leading experts from the NIAID. We are looking forward to the day M-001 will be approved as a key component of influenza prevention.”
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 US Food and Drug Administration (FDA), and participant recruitment is anticipated to begin after the end of the 2017/18 flu season.