Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248833
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2005-11-02
Brief Title:
Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
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 4476 MOS NOMV 5D Vaccine Admin to Healthy Subjs IM With and Without Adjuvant
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the vaccine called Group B Meningococcal 4476 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
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSRRB A-13513 | None | None | None |