Phase 1 meCS6 + LT(R192G) Vaccine Study - Full Text View

Sponsored by:	Walter Reed Army Institute of Research (WRAIR)
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00090688

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 I

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LT(R192G) Adjuvant in Volunteers

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

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

WRAIR Clinical Trials center website This link exits the ClinicalTrials.gov site

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

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

diarrhea

Study placed in the following topic categories:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive
Heat-labile enterotoxin, E coli

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009