NIH

“The first clinical trial of an innovative universal influenza vaccine candidate is examining the vaccine’s safety and tolerability as well as its ability to induce an immune response in healthy volunteers. Scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, developed the experimental vaccine, known as H1ssF_3928.

H1ssF_3928 is designed to teach the body to make protective immune responses against diverse influenza subtypes by focusing the immune system on a portion of the virus that varies relatively little from strain to strain. ….

 

The clinical trial is being conducted at the NIH Clinical Center in Bethesda, Maryland. It is being led by Grace Chen, M.D., of NIAID’s Vaccine Research Center (VRC) Clinical Trials Program. The trial will gradually enroll at least 53 healthy adults aged 18 to 70 years. The first five participants will be aged 18 to 40 years and will receive a single 20-microgram (mcg) intramuscular injection of the experimental vaccine. The remaining 48 participants 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. Investigators hope to understand how participants’ immune responses to the experimental vaccine may vary based on age and the likelihood of their previous exposure to different influenza variants.

Study participants will be asked to record their temperature and any symptoms on a diary card for one week after each injection. They also will be asked to visit the clinic to provide blood samples at various time points. Investigators will test the samples in the laboratory to characterize and measure levels of anti-influenza antibodies, which are potentially indicative of immunity against influenza. Participants will return for nine to 11 follow-up visits over 12 to 15 months. They will not be exposed to any influenza virus as part of the clinical trial…..”