Phase 1 meCS6 + LT(R192G) Vaccine Study

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00090688
First received: September 2, 2004
Last updated: January 31, 2006
Last verified: January 2006
  Purpose

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.


Condition Intervention Phase
Diarrhea
Biological: meCS6 + LT(R192G)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LT(R192G) Adjuvant in Volunteers

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Safety
  • Mucosal Immunogenicity
  • Systemic Immunogenicity

Estimated Enrollment: 60
Study Start Date: August 2004
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090688

Locations
United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20895
Sponsors and Collaborators
Walter Reed Army Institute of Research (WRAIR)
Investigators
Principal Investigator: Joyce Lapa, MD Naval Medical Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00090688     History of Changes
Other Study ID Numbers: WRAIR 1065, HSRRB A-12367
Study First Received: September 2, 2004
Last Updated: January 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014