Phase 1 meCS6 + LT(R192G) Vaccine Study

Diarrhea Clinical Trial

Official title: Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LT(R192G) Adjuvant in Volunteers

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea

• NCT number: NCT00090688
• Study type: Interventional
• Source: U.S. Army Medical Research and Materiel Command
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2004