The second phase of human trials for a universal flu vaccine has begun in the U.S., the National Institutes of Health announced Friday, as scientists continue to search for an all-encompassing solution to protecting against the unpredictable and constantly mutating virus.
The clinical trial, which will take place at four sites around the U.S., will enroll 120 healthy volunteers to either be injected with the experimental vaccine, called M-001, or a placebo.
Six previous clinical trials with a total of 698 participants in Israel and Europe established that M-001 was safe, well-tolerated and produced an immune response to a broad range of influenza strains, according to a statement by the NIH.
Participants who either receive the experimental vaccine or the placebo will also be injected with the seasonal flu vaccine.
Seasonal flu vaccine effectiveness ranges from year to year because scientists must decide which virus to develop a vaccine against before the season begins. Last year’s flu season, one of the most deadly on record, was plagued by a number of challenges, including low vaccine effectiveness and high rates of a flu strain that is inherently more aggressive.
“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,” National Institute of Allergy and Infectious Diseases Director Dr. Anthony S. Fauci, said in a statement.
Each year, seasonal influenza sickens millions in the United States and results in 140,000 to 710,000 hospitalizations and between 12,000 and 56,000 deaths, according to the federal Centers for Disease Control and Prevention.
“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.”