Actively Recruiting
Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Led by U.S. Army Medical Research and Development Command · Updated on 2021-02-11
500
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
CONDITIONS
Official Title
Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 to 65 years old at time of consent.
- Have RVF plaque reduction neutralization 80% titers (PRNT80) less than 1:10 for primary series.
- Have RVF PRNT80 less than 1:40 for booster series.
- If female of childbearing potential, agree to urine pregnancy test before each vaccine and not become pregnant for 3 months after last vaccination.
- Be at risk for exposure to RVF virus and have submitted a Request for IND Vaccines for the RVF vaccine.
- Sign informed consent and HIPAA Authorization.
- Have recent medical history, physical exam, lab tests, chest X-ray, and ECG results.
- Be medically cleared for participation by an investigator.
- Be willing to return for all follow-up visits.
- Agree to report any adverse events for at least 28 days after vaccination and serious adverse events during study.
- Agree to defer blood donation for 1 year after vaccination.
You will not qualify if you...
- Completed previous RVF vaccine study as a nonresponder (PRNT80 less than 1:40).
- Have clinically significant abnormal lab results or elevated liver function tests.
- Have history of immunodeficiency or recent immunosuppressive treatment.
- Have confirmed HIV infection.
- Have positive pregnancy test or be breastfeeding.
- Have allergies to vaccine components such as fetal rhesus monkey lung cells, formaldehyde, neomycin sulfate, streptomycin, sodium bisulfite, human serum albumin, or RVF virus (Entebbe strain).
- Received another vaccine or investigational product within 28 days.
- Have unresolved adverse events from prior immunizations.
- Have any medical condition that investigator judges may impact safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Special Immunization Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, United States, 21702
Actively Recruiting
Research Team
A
Anthony P Cardile, DO, MAJ
CONTACT
J
Jeannine M Haller, RN, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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