NIH Starts First Ever Human Trials For Possible Universal Flu Vaccine


The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, launched the clinical trial of an experimental vaccine to combat universal influenza.

The clinical trial is being held at Maryland, at the NIH Clinical Center. The program aims to examine if the vaccine is safe to take and if it induces an immune response to the volunteers.

Universal Influenza Vaccine

"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," says NIAID Director Anthony S. Fauci, M.D. "This Phase 1 clinical trial is a step forward in our efforts to develop a durable and broadly protective universal influenza vaccine."

The experimental vaccine is called H1ssF_3928, and it's basically intended to show the body how to develop protective immune reactions against diverse influenza subtypes by concentrating the immune system on a part of the virus that differs slightly little from strain to strain.

If successful, the future might see "universal" influenza vaccine that can provide lifelong protection for all individuals from multiple influenza subtypes, especially those that might cause a pandemic.

The clinical trial is headed by Grace Chen, M.D., of NIAID's Vaccine Research Center Clinical Trials Program, and supported by fellow VRC scientists.

Phase 1

At least 53 healthy adults aged 18 to 70 years will be tested for the clinical trial. The first wave will consist of five participants aged 18 to 40 years and will be given single 20-microgram (mcg) intramuscular injection of the experimental vaccine.

For the rest of the volunteers, they will be separated into four groups of 12 people each: 18 to 40 years, 41 to 49 years, 50 to 59 years, and 60 to 70 years. They will all receive two 60-mcg vaccinations spaced 16 weeks apart. Researchers are hoping to better understand the participants' immune responses based on the factors of age and the likelihood of their previous exposure to varying influenza strains.

After their initial injection, the volunteers will record any bodily response through a diary card for a week. They will also not be exposed to any type of influenza virus during the trial. Blood samples will also be gathered, and they are required to return for a series of follow-up visits, which will last over 12 to 15 months.

By the end of 2019, the VRC expects the clinical trial to complete enrollment so they can begin reporting the results by 2020.

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