Clinical Trial Tests Whether Topical Cream Can Boost Flu Vaccine Immune Response

Investigators are evaluating whether imiquimod cream, commonly used to treat genital warts and certain skin cancers, can boost the body’s immune response to an H5N1 influenza vaccine.

A Phase 1 clinical trial examining whether a topical cream can enhance the immune response conferred by a pre-pandemic influenza vaccine is under way at Baylor College of Medicine in Houston, the National Institutes of Health announced Sept. 5. Its release said investigators are evaluating whether imiquimod cream, commonly used to treat genital warts and certain skin cancers, can boost the body’s immune response to an H5N1 influenza vaccine.

The trial is enrolling 50 healthy adults ages 18-50 years. Baylor is one of the Vaccine and Treatment Evaluation Units (VTEUs) — a network of clinical research sites that can rapidly enroll large volunteer cohorts to evaluate experimental vaccines against infectious diseases. The VTEUs are funded and managed by the National Institute of Allergy and Infectious Diseases, part of NIH.

H5N1 is an avian influenza virus that causes severe respiratory illness in birds, and there have been human cases where the individuals contracted H5N1 influenza through direct or indirect contact with infected birds, such as poultry. Infections in people can be fatal; the World Health Organization reported 860 cases of H5N1 influenza, 454 of them fatal, from 2003 through July 20, 2018.

The release said participants in the Baylor College of Medicine trial will receive an H5N1 vaccine that was designed for use in a potential pandemic. The vaccine, developed with some NIAID support, is made from an inactivated flu virus, and was approved by the Food and Drug Administration in 2007. It was then added to the National Pre-pandemic Influenza Vaccine Stockpile.

"NIAID is pleased to support a clinical trial evaluating an innovative way to boost immune responses to a pre-pandemic vaccine," said NIAID Director Dr. Anthony S. Fauci, M.D. "The Vaccine and Treatment Evaluation Units remain a crucial component of our pandemic influenza preparedness efforts."

The first clinical trial participant was vaccinated on June 19, 2018. Investigators expect to have early study results by the end of 2018.

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