Phase 1 meCS6 + LT(R192G) Vaccine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090688
Recruitment Status : Withdrawn (IND was terminated for being inactive for more than five years)
First Posted : September 3, 2004
Last Update Posted : December 28, 2016
Information provided by:
U.S. Army Medical Research and Materiel Command

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.

Condition or disease Intervention/treatment Phase
Diarrhea Biological: meCS6 + LT(R192G) Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LT(R192G) Adjuvant in Volunteers
Study Start Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety
  2. Mucosal Immunogenicity
  3. Systemic Immunogenicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090688

United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20895
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Principal Investigator: Joyce Lapa, MD Naval Medical Research Center

Additional Information: Identifier: NCT00090688     History of Changes
Other Study ID Numbers: WRAIR 1065
HSRRB A-12367
First Posted: September 3, 2004    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: January 2006

Keywords provided by U.S. Army Medical Research and Materiel Command:

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