Status:
COMPLETED
Invaplex 50 Vaccine Dose-Ranging
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Diarrhea
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollm...
Detailed Description
This is an open-labeled dose escalating trial in which a total of 32 subjects (minimum of 24 allowable) will receive one of four intranasal Invaplex 50 vaccine doses according to the following chart: ...
Eligibility Criteria
Inclusion
- Be in very good health.
Exclusion
- Smoker, or have stopped smoking less than one year ago
- Pregnant
- History of chronic illnesses, such as: asthma, chronic sinusitis, or chronic seasonal allergies (such as hay fever)
- Received a vaccination for Shigella or exposure to Shigella bacteria in a research study or through work in a laboratory
- Positive for HIV, hepatitis B, and hepatitis C by blood test
- Using anti-diarrheal, anti-constipation, or antacid medications on a regular basis
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00082069
Start Date
April 1 2004
End Date
November 1 2006
Last Update
April 30 2015
Active Locations (1)
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1
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910