Clinical Trial: Invaplex 50 Vaccine Dose-Ranging


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Invaplex 50 Vaccine Dose-Ranging

This study is currently recruiting patients.

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

Purpose

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.

Condition	Treatment or Intervention	Phase
Diarrhea	Vaccine: Shigella flexneri 2a Invaplex 50	Phase I

MedlinePlus related topics: Diarrhea

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Official Title: Safety and Immunogenicity Study of an Intranasal Shigella flexneri 2a Invaplex 50 Vaccine

Further Study Details:

Expected Total Enrollment: 32

Study start: April 2004

Eligibility

Ages Eligible for Study: 18 Years - 40 Years, Genders Eligible for Study: Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Be in very good health.

Exclusion Criteria:

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

Location and Contact Information

Maryland
Walter Reed Army Institute of Research, Silver Spring, Maryland, 20910, United States; Recruiting

Oman Q Salazar 866-856-3259 clinical2@na.amedd.army.mil
Felicia L Breedy 866-856-3259 clinical2@na.amedd.army.mil
David R Tribble, MD, MPH, Principal Investigator

More Information

Clinical Trials Center website

Study ID Numbers: Invaplex50; 1085
Record last reviewed: April 2004
Record first received: April 28, 2004
ClinicalTrials.gov Identifier: NCT00082069
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09

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National Institutes of Health, Department of Health & Human Services