BiondVax Pharmaceuticals (NASDAQ, TASE:BVXV) signed a clinical trial agreement for a Phase 2 clinical trial with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
The study 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 hope that this important strategic collaboration will lead to additional partnerships with other leading institutions,” Dr. Ron Babecoff, CEO of BiondVax, said in a statement.
Dr. Tamar Ben-Yedidia, CSO of BiondVax, said that along with the company’s successful European Union Phase 2b clinical trial results, the NIAID study would further explore the science behind M-001.
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. They are 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 an IND to the FDA, and participant recruitment is anticipated to begin after the end of the 2017/2018 flu season.
