A clinical trial examining the effectiveness of a universal influenza vaccine is currently underway, according to the National Institutes of Health.
Officials said the National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Phase 2 effort focuses on M-001 as a means of garnering safety insight while assessing its ability to produce potentially broad protective immune responses, both on its own and when followed by a standard, seasonal influenza vaccine.
The work involves up to 120 healthy volunteers between the ages of 18 and 49 years assigned randomly to receive either two doses of the experimental vaccine or a placebo.
Participants will be vaccinated twice, receiving one dose of M-001 or placebo via intramuscular injection on the first day and a second dose 22 days later. Approximately 172 days later, all participants will receive an approved seasonal influenza vaccine. Each participant will be followed for approximately seven months.
“The 2017-2018 influenza season in the United States was among the worst of the last decade and serves as a reminder of the urgent need for a more effective and broadly protective influenza vaccine,” Dr. Anthony S. Fauci, NIAID director, said. “An effective universal influenza vaccine would lessen the public health burden of influenza, alleviate suffering and save lives. There are numerous paths of inquiry that the scientific community is pursuing, with each new study yielding more critical information and bringing us closer to our shared goal.”
The trial will take place at four NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs), with patients 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.