Phase 2
N=278
Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Rift Valley Fever
Bottom Line
View on ClinicalTrials.gov: NCT00584194 ↗Enrolled (actual)
278
Serious AEs
7.2%
Results posted
Jul 2017
Primary outcome: Primary: Safety: All Incidences of Erythema — 15; 10; 0 number of events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TSI-GSD 200 RVF Vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: All Incidences of Erythema |
15; 10; 0 | — |
| SECONDARY Immunogenicity: Geometric Mean Titers After 3rd Vaccination |
47.3; 74.9 | — |
| SECONDARY Immunogenicity: Geometric Mean Titers Before 6-month Booster |
8.5; 23.9 | — |
| SECONDARY Immunogenicity: Geometric Mean Titers at 12 Months |
48.8; 48.4 | — |
| SECONDARY Immunogenicity: Geometric Mean Titers After 6-month Booster |
211.8; 189.0 | — |
Summary
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
Eligibility Criteria
Inclusion Criteria
Parts A & B:
- At least 18 years old, or if active military duty, 17 years old,
- Females of childbearing potential must agree to have a urine pregnancy test within 48 hours before receipt of each dose of vaccine. The test results must be negative. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose, and must not be breast-feeding,
- Subject must be actively enrolled in the SIP to be vaccinated at USAMRIID or be otherwise authorized (with documentation) by the DOD
- Subjects must be at risk for exposure to RVF virus,
- Subjects must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in their charts and be medically cleared for participation by an investigator. Examinations or tests may be repeated within 1 year at the discretion of the enrolling physician.
- Volunteer must have signed and dated the approved informed consent (Volunteer Agreement Explanation and Affidavit).
Additional Inclusion Criteria for Part B:
- Completion of primary series and any follow-up titer (PRNT80) < 1:40 from the current or a previous RVF IND 365 protocol.
Exclusion Criteria
Parts A & B:
- Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B or carrier state, or elevated liver function tests.
- Personal history of immunodeficiency or current treatment with immunosuppressive medication, at the discretion of the physician.
- Confirmed HIV infection.
- Any medical condition that, at the discretion of the physician, may jeopardize the safety of the volunteer.
- Any serious or life-threatening allergies to any component of the vaccine: formalin, human serum albumin, neomycin, streptomycin
- Administration of any other vaccine within 28 days of any dose of RVF vaccine.
- Any unresolved adverse event resulting from a previous immunization.
Additional Exclusion Criteria for Part B:
- An adequate PRNT80 (≥ 1: 40) after completion of primary series.
Data sourced from ClinicalTrials.gov (NCT00584194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.