Invaplex 50 Vaccine Dose-Ranging

Completed · Phase 1

Conditions studied: Diarrhea

In brief

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 enrollment with consideration of their availability to complete the necessary vaccinations and follow-up visits.

Key facts

Study ID

NCT00082069

Run by

U.S. Army Medical Research and Development Command

People needed

32

Starts

2004-04-01

Expected to finish

2006-11-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be in very good health.

You may not qualify if…

• 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

Where it is running

• Walter Reed Army Institute of Research — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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