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Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Official title: A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
2606
Start Date
2020-12-29
Completion Date
2026-10-01
Last Updated
2026-03-20
Healthy Volunteers
Yes
Conditions
Interventions
Meningococcal Group B Vaccine
A combination vaccine consisting of rMenB and OMV NZ.
Placebo
150mM sodium chloride (0.9% saline solution).
Locations (13)
University of Alabama at Birmingham School of Medicine - Infectious Disease
Birmingham, Alabama, United States
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
SFDPH Bridge HIV Center
San Francisco, California, United States
Emory University School of Medicine - The Ponce de Leon Center
Atlanta, Georgia, United States
Emory University Hospital Midtown - Emory Clinic Infectious Diseases
Atlanta, Georgia, United States
University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
Chicago, Illinois, United States
LSU - CrescentCare Sexual Health Center
New Orleans, Louisiana, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Harlem Prevention Center, Columbia University, Mailman School of Public Health
New York, New York, United States
University of Pennsylvania HIV/AIDS Prevention Research Division
Philadelphia, Pennsylvania, United States
Malawi Clinical Research Site, Lilongwe
Lilongwe, Central Region, Malawi
The Thai Red Cross AIDS Research Centre
Bangkok, Thailand
Armed Forces Research Institute of Medical Sciences - Royal Thai Army Clinical Research Center
Bangkok, Thailand