Clinical Trial: Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 1 Dose Esc Study of Safety and Immun of 3 Injections, Given at 0, 6 and 24 Wks, of Grp B Meningococcal 44/76 MOS NOMV 5D Vaccine Admin to Healthy Subjs IM With and Without Adjuvant
Brief Summary:
The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis.
This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.
Detailed Summary:
Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that can kill children and young adults very quickly. Meningococci are divided into distinct sergroups based on their polysaccharide outer capsule, which is the usual target antigen for vaccines. Serogroup A is the main cause of epidemics in Africa and in the United States, sergroups B, C and Y predominate. In the United States, no vaccine is yet available to offer protection against serogroup B which currently accounts for 32% of all meningococcal disease in the United States.
This study serves as a proof of concept for our new NOMV Group B single strain monovalent vaccine model which is obtained from a genetically modified parent. If successful we plan to develop a multivalent Group B vaccine for routine use for military recruits at the beginning of basic training, for college students, particularly those who live in dormitories, and for use by travelers to countries recognized as having hyperendemic disease.
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome: Type and frequency of adverse events over a 7 day follow-up period.
Original Primary Outcome: Same as current
Current Secondary Outcome: Seroconversion >= 50% after two doses of vaccine would meet minimum criteria for further vaccine development.
Original Secondary Outcome: Same as current
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: November 2, 2005
Date Started: December 2005
Date Completion:
Last Updated: October 25, 2016
Last Verified: April 2010
