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Trial Testing Universal Nasal Spray Flu Vaccine in Children

Train pssengers in masks

Metro train passengers in Mexico City wearing masks to protect against flu transmission in 2009. (Eneas De Troya, Flickr)

17 September 2018. A clinical trial is underway evaluating a vaccine given as a nasal spray among children and teens that promises to protect against multiple flu types. The study is sponsored by National Institute of Allergy and Infectious Diseases or NIAID, part of National Institutes of Health, as part of its goal to find a vaccine that protects against a broad range of flu strains.

The virus causing flu outbreaks has two main types known as influenza A and B. Influenza A viruses emerge as different strains from the composition of proteins on their surface, called hemagglutinin and neuraminidase, abbreviated to H and N. The various influenza A strains are made up of combinations of 18 H and 11 N proteins. The continuous mutation of flu viruses, particularly influenza A, makes the disease difficult to contain from year to year.

Different flu strains emerge each annual flu season, and public health authorities need to prepare well in advance to anticipate the strains likely to arrive, then develop, produce, and distribute seasonal vaccines to protect against those strains. If the annual predictions miss the correct mix of influenza strains, the seasonal flu vaccines are less effective. According to Centers for Disease Control and Prevention, influenza results in as many as 710,000 hospitalizations and 56,000 deaths each year in the U.S.

NIAID is seeking ways to break from the annual guessing game of seasonal influenza strains with a single vaccine that protects against a range of flu types. One of the vaccines under study is RedeeFlu made by the company FluGen Inc. in Madison, Wisconsin. RedeeFlu is given as a nasal spray with a genetically altered flu virus that replicates only once in the body, enough to trigger an immune response, but not enough to cause an illness. In this study, the researchers are using the H3N2 strain found in some seasonal flu formulations. The H3N2 strain was a prominent part of the 2017-18 flu season.

The study team is testing the safety and immune-system response of RedeeFlu with H3N2, given three months in advance of a regular flu shot. The clinical trial held at St. Louis University is recruiting 50 healthy children and adolescents, age 9 to 17, randomly assigned to receive a single dose of the RedeeFlu nasal spray or a placebo nasal spray. Three months later all participants will receive a normal flu vaccine covering the four anticipated strains for the upcoming flu season.

The researchers believe the restricted H3N2 virus will generate a strong immune response not only against H3N2, but also one that carries over to stop other strains. The team will look primarily for adverse reactions in the first three months, and monitor participants’ health for a year. The researchers will also take blood samples from participants at three times after the nasal spray, and another blood test after the regular flu shot, looking for specific antibodies in the participants’ blood.

FluGen is a spin-off enterprise from University of Wisconsin in Madison, founded in 2007 by virologists Yoshihiro Kawaoka and Gabriele Neumann in the university’s veterinary medicine school, who conducted research on genetically-engineered and synthetic viruses that led to development of FluGen’s technology. Kawaoka and Neumann are now consultants to FluGen. The company already conducted an early-stage safety study of RedeeFlu with adults and is now testing its efficacy among adults in an intermediate-stage study.

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