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.
Anixa Biosciences transfers breast cancer vaccine IND from Cleveland Clinic
Sanofi completes acquisition of Vicebio to expand respiratory vaccines portfolio
Valneva reports positive final Phase 2 results for Lyme disease vaccine VLA15
Lunai Bioworks receives first LOI to license next-generation immune cell therapy
BioNet receives positive opinion from EMA for VacPertagen marketing authorisation in EU
Anixa Biosciences secures U.S. Patent strengthening breast cancer vaccine IP into mid 2040s
PharmaJet® and EVA Pharma Partner to Scale Needle-free Polio Immunisation Across Egypt
Frontier IP portfolio company achieves breakthrough in livestock vaccine trials
GC Biopharma's Phase 2 clinical trial results for BARYTHRAX published in Vaccine
Bavarian Nordic secures new EU contract for up to 8 million smallpox and mpox vaccine doses