Meningococcal Group B Vaccine for Gonorrhea
Trial Summary
What is the purpose of this trial?
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 primary endpoints in the Per Protocol Population. 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive agents or systemic corticosteroids, you may not be eligible to participate. It's best to discuss your specific medications with the trial staff.
What data supports the effectiveness of the treatment Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) for gonorrhea?
Research suggests that the Meningococcal Group B Vaccine, which includes the OMV component, may offer moderate protection against gonorrhea, with studies showing a 30% to 40% effectiveness in reducing gonorrhea rates. This is likely due to the close relationship between the bacteria causing meningococcal disease and gonorrhea, allowing the vaccine to trigger an immune response that helps protect against both.12345
Is the Meningococcal Group B Vaccine (Bexsero) safe for humans?
How does the Meningococcal Group B Vaccine (Bexsero) differ from other treatments for gonorrhea?
The Meningococcal Group B Vaccine (Bexsero) is unique because it was originally developed to protect against meningococcal disease but has shown potential to also protect against gonorrhea, a condition with no existing vaccine. This vaccine contains outer membrane vesicles (OMV) and recombinant proteins, which may provide cross-protection against the bacteria causing gonorrhea.134711
Eligibility Criteria
This trial is for men and women aged 18-50 who are in good health, not pregnant or breastfeeding, and have not had gonorrhea or chlamydia recently. They shouldn't have received a Meningococcal Group B vaccine before or taken certain antibiotics or immunosuppressants recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two doses of the study product (Bexsero or placebo) administered as intramuscular injections, two months apart
Follow-up
Participants are monitored for safety and effectiveness after treatment, with clinic visits at 3-month intervals
Treatment Details
Interventions
- Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero)
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Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor