Not Signed In -
Diarrhea |
Dysentery |
Clinical Trial: Invaplex 50 Vaccine Dose-Ranging
This study is currently recruiting patients.
|
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
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
Felicia L Breedy 866-856-3259 clinical2@na.amedd.army.mil
David R Tribble, MD, MPH, Principal Investigator
More Information
Clinical Trials Center website
Record last reviewed: April 2004
Last Updated: October 13, 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 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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