A Phase 2 trial of an investigational universal influenza vaccine intended to protect against multiple strains of the virus has begun in the United States. The study, which is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is being conducted at four U.S. sites that are part of the NIAID-funded Vaccine and Treatment Evaluation Units. Patients will be enrolled at Baylor College of Medicine, the University of Iowa in Iowa City and Cincinnati Children’s Hospital Medical Center with laboratory support provided by the University of St. Louis. Dr. Robert Atmar, professor of infectious diseases at Baylor, is serving as the lead principal investigator of this clinical trial.
“There is a great need to develop a vaccine that protects against all strains of influenza and doesn’t need to be changed from year to year,” Atmar said. “We hope that this study is a step in that direction.”
The study will test an experimental vaccine called M-001, developed by BiondVax, for safety and its ability to produce potentially broad protective immune responses, on its own and when followed by a standard licensed seasonal influenza vaccine.
The trial is designed to enroll p to 120 healthy volunteers, who will be randomly assigned to receive two doses of either the experimental vaccine or a placebo. Those in the experimental group will receive one dose of the vaccine on the first day of their study participation, and a second 22 days later. After about 172 days, all participants will receive an approved seasonal non-universal influenza vaccine. Researchers will evaluate the immune responses of the participants to the experimental universal vaccine and the seasonal vaccine. Each participant will be followed for about seven months.