Investigators from the Baylor College of Medicine began phase 1 clinical trials this week for a topical cream designed to enhance immune response granted by an influenza vaccine.
The cream, known as imiquimod, is more commonly known for its use on genital warts and skin cancers because of its activation of the innate immune system. Now, investigators want to see if it can boost the body’s immune response to H5N1 influenza vaccine. H5N1 — avian influenza — causes severe respiratory illness in birds, though it has shown the ability to infect humans, leading to fears that genetic evolutions down the road could make it more easily spread.
The National Institute of Allergy and Infectious Diseases (NIAID) is funding the study.
“NIAID is pleased to support a clinical trial evaluating an innovative way to boost immune responses to a pre-pandemic vaccine,” NIAID Director Anthony Fauci said. “The Vaccine and Treatment Evaluation Units remain a crucial component of our pandemic influenza preparedness efforts.”
For this trial, the study team is testing the possibilities of the topical cream on 50 adults aged 18-50 years. Participants will be split into two treatment groups, either receiving the imiquimod or placebo as well as a dose of the H5N1 vaccine. Blood draws will be tested over the next seven months, with independent data and safety monitoring undertaken by a committee.