Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
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.
Meningitis, Meningococcal, Serogroup B
Biological: Meningococcal 44/76 MOS NOMV 5D
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|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|
- Type and frequency of adverse events over a 7 day follow-up period.
- Seroconversion >= 50% after two doses of vaccine would meet minimum criteria for further vaccine development.
|Study Start Date:||December 2005|
|Study Completion Date:||December 2007|
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.
|United States, Maryland|
|Walter Reed Army Institute of Research, Clinical Trials Center|
|Silver Spring, Maryland, United States, 20910|
|Principal Investigator:||Barnett Gibbs, MD||Walter Reed Army Institute of Research (WRAIR)|