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ACTIVE NOT RECRUITING
NCT04350138
PHASE2

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)

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Meningococcal Group B Vaccine

A combination vaccine consisting of rMenB and OMV NZ.

OTHER

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