University of Alabama at Birmingham researchers have been awarded a three-year contract with a total potential amount of $10 million to study the efficacy of the vaccine Bexsero — already licensed to prevent meningitis — in protecting vulnerable populations from infection with the bacteria that causes gonorrhea.
The contract awarded is for $3.5 million in 2019, with the total funding anticipated to be up to $10 million over three years, depending on how the study progresses.
The contract from the National Institute of Allergy and Infectious Diseases (NIAID) will be used to conduct a clinical trial at UAB and two additional sites. UAB will work with NIAID and other partners at Emory University and Louisiana State University on this study.
The phase II randomized, observer-blind, placebo-controlled study is the first and only large-scale trial to study a vaccine for gonorrhea. It could have tremendous impact on the growing public health problem of increasing rates of gonorrhea and other sexually transmitted infections. There are more than 580,000 newly diagnosed cases of gonorrhea in the United States each year, which contributes to increased risk of new HIV infections, as well as affecting women’s reproductive health.
STIs such as gonorrhea are especially common in the southeast United States, and there is only one class of antibiotics — cephalosporins — to treat this infection; several cases of treatment failure with that drug have been reported. This study will help researchers get closer to determining how to protect people from contracting gonorrhea, as antibiotic resistance rates increase.
“Vaccines represent a crucial path forward to ensuring the health of the population in the United States, and a vaccine for this infection could enhance the reproductive and sexual health of millions of people globally. It’s really exciting,” said Jeanne Marrazzo, M.D., MPH, director of UAB’s Division of Infectious Diseases and principal investigator of the study.
Approximately 2,000 volunteers at risk for gonorrhea will be enrolled at lead site UAB and partner sites. They will be randomly assigned to either Bexsero or a placebo injection, and observed to follow their risk of getting gonorrhea over time. All will be counseled on the best ways to avoid becoming infected with STI, including HIV. Researchers hope that, in addition to studying whether Bexsero helps prevent new gonorrhea infections, they will also be able to determine more about how this protection happens.
This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201300012I.