Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine (NCT03609398)
A Phase 2 Open Label Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated, Dried, TSI-GSD 200, Lot 7, Run 2, in Adult Subjects at Risk of Exposure to Rift Valley Fever Virus
🩺 Plain-English Summary (8th-Grade Level)
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (17 items).
Location: Special Immunization Program, Division of Medicine, USAMRIID — Fort Deterick, Maryland
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Have completed previous RVF vaccine study as a nonresponder (PRNT80 \<1:40).
- Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
- Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
- Have confirmed HIV infection.
- Have positive pregnancy test or be breastfeeding female.
- Have any known allergies to components of the vaccine:
- Fetal rhesus monkey lung cells
- Formaldehyde
- Neomycin sulfate
- Streptomycin
- Sodium bisulfite
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Special Immunization Program, Division of Medicine, USAMRIID — Fort Deterick, Maryland
📞 Contact the Study Coordinator
Phone: (301) 619-8833
Email: anthony.p.cardile.mil@mail.mil
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rift Valley Fever
- Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011 — Cypress, California
Explore by condition: All Rift Valley Fever clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.