Clinical Trial: Group B Meningococcal Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Dose-Escalation Study of the Safety and Immunogenicity of Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Hea

Brief Summary: The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other genetically modified strains as a potentially globally effective vaccine against group B meningococcus.

Detailed Summary:
Sponsor: U.S. Army Office of the Surgeon General

Current Primary Outcome: Clinical and laboratory adverse events; development of bactericidal antibodies to the parent strain of group B meningococcus

Original Primary Outcome: Same as current

Current Secondary Outcome: Total antibody response to the parent strain of group B meningococcus

Original Secondary Outcome: Same as current

Information By: Walter Reed Army Institute of Research (WRAIR)

Dates:
Date Received: May 8, 2008
Date Started: April 2008
Date Completion:
Last Updated: December 1, 2010
Last Verified: December 2010