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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00090688
• Other study ID #: WRAIR 1065
• Secondary ID: HSRRB A-12367
• Status: Withdrawn
• Phase: Phase 1
• First received: September 2, 2004
• Last updated: December 27, 2016
• Start date: August 2004

Study information

• Verified date: January 2006
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Available for required follow-up period

• Women must have a negative pregnancy test

• Women must not to try to become pregnant while on study and for 2 months after study is completed

Exclusion Criteria:

• History of travellers' diarrhea

• Occupation that involves handling of E. coli or cholera bacteria, or E. coli vaccine

• Regular use of anti-diarrheal, anti-constipation, or antacid therapy

• Abnormal bowel habits

• Pregnant or nursing women

• History of chronic gastrointestinal illness or major gastrointestinal surgery

• Allergies to vaccines

• Positive HIV, Hepatitis B or Hepatitis C tests

• Regular use of oral steroid medication

• Clinically significant abnormalities on physical examination

Study Design

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

Related Conditions & MeSH terms

• Diarrhea

Intervention

Biological:
• meCS6 + LT(R192G)

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Mucosal Immunogenicity
Primary	Systemic Immunogenicity

External Links

•   WRAIR Clinical Trials center website