Universal influenza vaccine enters first-in-human trial
Volunteers are set to begin phase 1 of the first-in-human trial of an experimental vaccine (H1ssF_3928) developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. According to the agency’s announcement yesterday, they plan to enroll at least 53 healthy adults aged 18 to 70 years with the initial goal of determining the vaccine’s safety, tolerability, and whether it can induce an immune response against a variety of influenza subtypes.
The researchers are aiming to use this trial in a broader research agenda that would lead to the availability of an influenza vaccine that gives lasting protection to all age groups and be strong enough to stop the spread of novel strains that could cause a pandemic.
The clinical trial, led by Grace Chen, M.D., of NIAID’s Vaccine Research Center (VRC) Clinical Trials Program, is taking place at the NIH Clinical Center in Bethesda, Maryland. NIH said five participants aged 18 to 40 years will be vaccinated with a single 20-microgram (mcg) intramuscular injection and the remaining 48 volunteers will receive two 60-mcg vaccinations spaced 16 weeks apart. They will be stratified by age into four groups of 12 people each: 18 to 40 years, 41 to 49 years, 50 to 59 years, and 60 to 70 years in an effort to understand how immune responses vary among people of different ages, as well as the likelihood they were exposed previously to different influenza variants.
Study participants will record temperature and any symptoms one week after each injection, provide blood samples and return to the clinic up to 11 times for follow-up examination for 12 to 15 months. NIH said none of the participants will be exposed to any influenza virus during the clinical trial.
“This Phase 1 clinical trial is the culmination of years of research and development made possible by the unique collaborative setting that the VRC offers by bringing together top scientists, manufacturing expertise, and an outstanding clinical team,” said VRC Director John Mascola, M.D.
The VRC expects the clinical trial to complete enrollment by the end of 2019 and hopes to begin reporting results in early 2020. For more information about the trial, visit ClinicalTrials.gov and search identifier NCT03814720.
Visit NIH for specific details on how the vaccine was developed.
