A Phase 2 clinical trial of an investigational universal influenza vaccine intended to protect against multiple strains of the virus has begun in the United States. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is being conducted at four U.S. sites that are part of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs).
The trial is testing an experimental vaccine called M-001 for safety and its ability to produce potentially broad protective immune responses, both on its own and when followed by a standard, licensed seasonal influenza vaccine.
Influenza viruses mutate constantly, resulting in the emergence of viruses that may not always match those targeted by seasonal and pre-pandemic influenza vaccines. Seasonal influenza vaccines are made anew each year to match the strains predicted to circulate in the upcoming season. To receive the best protection against influenza, people must be vaccinated annually.
The new study will enroll up to 120 healthy volunteers between the ages of 18 and 49 years. Participants will be assigned randomly to receive either two doses of the experimental vaccine or a placebo. The trial will take place at four NIAID-funded VTEUs. Patients will be enrolled at the Baylor College of Medicine; the University of Iowa in Iowa City; and Cincinnati Children’s Hospital Medical Center. Laboratory support will be provided by Saint Louis University.