Meningococcal Group B vaccine Bexsero for Gonorrhea Prevention

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Study Overview

The main purpose of this study is to learn if a vaccine that is given as two shots (injections) to prevent spinal meningitis (an infection of the lining of the brain and spinal cord caused by Neisseria meningitidis type B) might also work in preventing gonorrhea (caused by Neisseria gonorrhoeae). The vaccine we plan to use in this study is called Bexsero and has been approved by the US Food and Drug Administration (FDA) and other countries for the prevention of meningitis.

Study Description

This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 evaluable participants. Data will be collected in an observer-blind manner. Study product recipients and study staff responsible for the evaluation of any study endpoint will be unaware of whether Bexsero or placebo were administered. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. Study participation is expected to be completed in approximately 36 months. The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection.

  • Study Identifier: IRB-300005422

Recruitment Status


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