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Pharmaceutical Technology's In the Lab eNewsletter
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded grants totaling $41.6 million to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs).
On May 9, 2019, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced awards to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs). The grants, totaling $41.6 million over five years, will support collaborative, multidisciplinary research on the bacteria that cause syphilis, gonorrhea, and chlamydia. At the end of the program, each center is expected to identify at least one candidate vaccine ready for testing in clinical trials.
The centers funded through this new program all involve multiple research institutions in the United States as well as international collaborators. Each center will conduct at least three research projects organized on a common theme. The centers will be supported by scientific cores that will supply shared research services, including monoclonal antibody production, microbiology laboratory services, and statistical expertise.
One center based at the University of Connecticut (UConn) Health School of Medicine will receive up to $11 million over five years to study syphilis. This center will be headed by UConn Health School of Medicine Professor Justin Radolf, MD, and Duke University Associate Professor Michael Anthony Moody, MD. In 2017, 30,644 cases of early syphilis were reported in the United States, an increase of 76% since 2013, according to the Centers for Disease Control and Prevention (CDC). The study team will build on earlier findings using structural biology approaches to investigate surface-exposed proteins within the outer membrane of Treponema pallidum, the bacterium that causes syphilis, which they believe could serve as targets for a vaccine.
Two of the centers are focused on gonorrhea, an STI caused by Neisseria gonorrhoeae. More than half a million gonorrhea diagnoses were reported in the US in 2017, an increase of 67% from 2013, according to the CDC. Especially concerning is the fact that the bacteria that cause gonorrhea have become resistant to most antibiotics. In recent years, the CDC reported that ceftriaxone is the only remaining highly effective antibiotic left to treat gonorrhea in the US.
The gonorrhea vaccine cooperative research center (GV CRC) will receive up to $10.7 million over five years. Led by Ann Jerse, PhD, of the Uniformed Services University of Health Sciences, four research projects in the GV CRC will study immune signals that may provide evidence that candidate gonorrhea vaccine has induced immunity. Among other projects, the team will assess samples from people and mice previously vaccinated with a candidate vaccine, 4CMenB, for which there is evidence of protection against gonorrhea, according to NIH.
A center based at Georgia State University and headed by Cynthia Cornelissen, PhD, will receive up to $9.25 million over five years. Projects at this center will focus on interfering with bacterial nutrient transport as a protective strategy against gonococcal bacteria. They plan to develop vaccine candidates that target bacterial systems needed to acquire iron and zinc, thus starving the bacteria of required nutrients. One project will model the effectiveness of possible gonococcal vaccine formulations using protein antigen diversity information, antibiotic resistance prevalence, and community acceptance data.
A fourth center, based at the University of North Carolina (UNC) at Chapel Hill and led by Toni Darville, MD, of the UNC School of Medicine, will receive up to $10.7 million over five years to advance chlamydia vaccine research. Chlamydia trachomatis is the most common sexually transmitted bacterial pathogen in the world. CDC estimates that at least 1.7 million cases of chlamydia were diagnosed in the US in 2017, 45% of which were in women aged 15 to 24 years.
Projects planned by the UNC-Chlamydia Vaccine Initiative Cooperative Research Center include one that will follow a group of women at high risk of chlamydia re-infection for a year after antibiotic treatment to better understand immune responses to the infection. A subsequent project will use information gathered from studying women’s immune system responses to chlamydia infection as a guide for developing candidate vaccines with the capacity to elicit robust T-cell responses, which are believed to be essential in protecting against infection with chlamydia. Additionally, NIAID expects to make two additional awards in this program later in 2019.
“STI research has recently evolved rapidly on multiple fronts, and this new knowledge can now be applied to a critical remaining challenge-the development of safe and effective vaccines for diseases that pose significant and growing public health burdens,” said NIAID Director Anthony S. Fauci, MD, in the institute’s press release. “At this time, no vaccines are available to prevent syphilis, gonorrhea, or chlamydia. However, research at these new centers should help fill the pipeline with several vaccine candidates that have feasible pathways to licensure in the US.”