Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090688
Status:
WITHDRAWN
Last Update Posted:
2016-12-28
First Post:
2004-09-02
Brief Title:
Phase 1 meCS6 LTR192G Vaccine Study
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LTR192G Adjuvant in Volunteers
Status:
WITHDRAWN
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IND was terminated for being inactive for more than five years
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will enroll approximately 60 volunteers The vaccine is given as a drink in flavored soda water Volunteers will either receive a 3-dose vaccination with doses spaced two weeks apart or a 4-dose vaccination with doses spaced 2 days apart depending upon their availability for follow-up
Once assigned to a vaccination schedule volunteers will be randomly assigned to receive the meCS6 vaccine with or without the mLT adjuvant for all vaccine doses Neither the study investigators nor the volunteers will know which group they are assigned
Volunteers will be asked to be available for clinic visits and telephone follow-ups during the study period and provide blood and stool specimens for testing
Once assigned to a vaccination schedule volunteers will be randomly assigned to receive the meCS6 vaccine with or without the mLT adjuvant for all vaccine doses Neither the study investigators nor the volunteers will know which group they are assigned
Volunteers will be asked to be available for clinic visits and telephone follow-ups during the study period and provide blood and stool specimens for testing
Detailed Description:
The Phase 1 section of this study is a randomized double blind trial in which a total of 60 subjects minimum of 52 allowable will receive on of two oral vaccine doses according to the following chart
Group Subset N CS6Encapsulated LTR192G I A 15 095mg 2 micrograms II B 15 095mg -- III A 15 095mg 2 micrograms IV B 15 095mg --
minimum of 13 volunteersgroup
Volunteers in Group I will receive three immunizations study days 0 14 and 28 during the vaccine series Volunteers in Group II will receive four immunizations study days 0 2 4 and 6 during the vaccine series The two groups will be vaccinated separately for logistical purposes Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses Vaccine safety will be actively evaluated during vaccination and for 4 weeks following the final vaccine dose
Group Subset N CS6Encapsulated LTR192G I A 15 095mg 2 micrograms II B 15 095mg -- III A 15 095mg 2 micrograms IV B 15 095mg --
minimum of 13 volunteersgroup
Volunteers in Group I will receive three immunizations study days 0 14 and 28 during the vaccine series Volunteers in Group II will receive four immunizations study days 0 2 4 and 6 during the vaccine series The two groups will be vaccinated separately for logistical purposes Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses Vaccine safety will be actively evaluated during vaccination and for 4 weeks following the final vaccine dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-12367 | None | None | None |