Meningococcal Immunization Against Gonococcal Infection (MAGI) Trial/ RV564

Background
The Infectious Diseases Clinical Research Program (IDCRP) is a U.S. Military tri-service research center headquartered within the F. Edward Hebert School of Medicine at the Uniformed Services University (USU). Its mission is to perform multicenter, observational, and interventional clinical infectious disease research within the Military Health System (MHS) that informs and improves the care of the Warfighter.

Work Details
The purpose of this funding is to support the execution of a phase II randomized, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero©, GSK) in preventing gonococcal infection. The study design is based on the accrual of incident cases of gonococcal infection to determine the final enrollment which will support a time to evidence analysis.
Both domestic and international sites are needed allowing for accrual from a robust global subject pool to complete subject enrollment. The prime contractor will be required to partner with various collaborators associated with the ongoing trial and present an overarching management plan for coordination and execution of both the extramural and intramural activities.

Period of Performance
The study is expected to continue to enroll at all current sites into FY23 with follow up to continue into FY25.

Place of Performance
The contract will be performed at various locations including Walter Reed National Military Medical Center, Thai Red Cross (TRC)/IHRI, Royal Thai Army (RTA), and other academic institutions.