Phase 1 meCS6 + LT(R192G) Vaccine Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LT(R192G) Adjuvant in Volunteers|
- Mucosal Immunogenicity
- Systemic Immunogenicity
|Study Start Date:||August 2004|
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 CS6(Encapsulated) LT(R192G) I A 15 0.95mg 2 micrograms II B 15 0.95mg -- III A 15 0.95mg 2 micrograms IV B 15 0.95mg --
*minimum of 13 volunteers/group
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.
|United States, Maryland|
|Walter Reed Army Institute of Research|
|Silver Spring, Maryland, United States, 20895|
|Principal Investigator:||Joyce Lapa, MD||Naval Medical Research Center|