The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, started the first in-human clinical trial of a new universal influenza vaccine candidate.
The experimental vaccine, known as H1ssF_3928, was developed to help the body respond to different flu subtypes by focusing on the aspects of the virus that remain mostly the same among various strains.
The trial will enroll at least 53 adults, ranging from 18 to 70 years. The first five participants, aged 18 to 40 years, will receive a single 20-microgram injection of the vaccine, while the remaining participants will receive two 60- microgram injections spaced 16 weeks apart.
Participants will record their temperature and note down symptoms in a diary for one week after each injection. They will also provide blood samples at the NIH Clinical Center in Bethesda, Md., at certain points. They will have 11 follow-up visits over 12 to 15 months.
"Seasonal influenza is a perpetual public health challenge, and we continually face the possibility of an influenza pandemic resulting from the emergence and spread of novel influenza viruses," said NIAID Director Anthony S. Fauci, MD. "This Phase 1 clinical trial is a step forward in our efforts to develop a durable and broadly protective universal influenza vaccine."