Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Part of paid clinical trials in Fort Deterick, Maryland.
- Sponsor
- U.S. Army Medical Research and Development Command
- Study ID
- NCT03609398
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Rift Valley Fever
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- RVF Vaccine — BIOLOGICAL1.0 mL dose given SQ in upper arm
Study Details
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
Key Dates
- Start date
- Oct 4, 2018
- Status verified
- Feb 2021
- Primary completion
- Dec 31, 2023
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: RVF Vaccine1.0 mL dose given SQ in upper arm
Primary Outcome Measure
Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine [ Time Frame: 0-28 days after each dose ]
Central Contacts
- Anthony P Cardile, DO, MAJ301-619-8833
- Jeannine M Haller, RN, CCRP301-619-4652
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Special Immunization Program, Division of Medicine, USAMRIID | Fort Deterick | Maryland | 21702 | Anthony P Cardile, DO, MAJ (PRINCIPAL_INVESTIGATOR) Jason A Regules, MD, FACP, LTC (SUB_INVESTIGATOR) Elena H Kwon, DO, MPH, MAJ (SUB_INVESTIGATOR) Arthur C Okwesili, DO, MPH, MAJ (SUB_INVESTIGATOR) Maryam K Jahromi, MD, MPH (SUB_INVESTIGATOR) Ronald B Reisler, MD, MPH (SUB_INVESTIGATOR) |