A Phase II randomized, observer-blind, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero) in preventing gonococcal infection
|Male and Female Patients
|U.S. Govt. ID:
|Nora Howell: 917-841-4125 / firstname.lastname@example.org
We are looking for adult volunteers to help us see if the FDA-approved Bexsero meningitis B vaccine can prevent people from getting gonorrhea infections. There are over 580,000 cases of gonorrhea diagnosed annually in the United States. Gonorrhea infections can significantly affect short and long-term reproductive health and contribute to increasing HIV transmission. Gonorrhea can be treated with antibiotics, but drug resistance is a significant issue. There is no effective vaccine currently approved for preventing gonorrhea. There are some studies that suggest that an FDA-approved vaccine for a related bacteria, Neisseria meningitidis serogroup B (a common cause of meningitis in young adults), may offer protection against gonorrhea. The meningitis B vaccine includes some proteins that are on the surface of both the meningitis and the gonorrhea bacteria. This study will assess the safety and effectiveness of an FDA-approved meningococcal B vaccine called rMenB+OMV NZ (Bexsero) - in preventing gonorrhea infections. The study includes a placebo arm; participants will be randomly assigned in a 1:1 ratio to receive two doses of either the active Bexsero vaccine (1,100 individuals) or a placebo vaccine (1,100 individuals), for a total of about 2,200 study participants. The 2 vaccine injections are given two months apart - at the enrollment visit and at a visit two months later. Participants are followed in the study and have 8 required in-person visits over a total period of about 16 months. The study involves blood draws and urine testing and rectal and throat swab collection for gonorrhea testing. Study participants are compensated for their time. Not sure if you are eligible? Take the first step and request to be contacted by our study team. We'll follow up by asking you to complete a brief electronic prescreen questionnaire to find out if you meet basic study criteria.
Sharon Mannheimer, MD
|Are between the ages of 18-50?
|Have you been sexually active within the last 30 days?
|Do you plan to remain in the New York City area for the next year and a half?
|Would you be willing to receive an FDA-approved vaccine as part of a research study?