Safety and Immunogenicity Study of an Intranasal Shigella Flexneri 2a Invaplex 50 Vaccine

NCT00082069 Phase 1 COMPLETED

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.

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2004-04
Completion	2006-11

Conditions

• Diarrhea

Interventions

• Shigella flexneri 2a Invaplex 50

Primary outcomes

• Safety
• Mucosal immune response
• Systemic immune response

Countries

United States