Rift Valley Fever Clinical Trial
— RVFOfficial title:
Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study
NCT number | NCT00584194 |
Other study ID # | A-12592 |
Secondary ID | FY03-05 |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2004 |
Est. completion date | May 2010 |
Verified date | December 2019 |
Source | U.S. Army Medical Research and Development Command |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
Status | Completed |
Enrollment | 278 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | U.S. Army Medical Research Institute of Infectious Diseases | Fort Deterick | Maryland |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Development Command |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: All Incidences of Erythema | Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study | 12 months | |
Secondary | Immunogenicity: Geometric Mean Titers After 3rd Vaccination | Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study) | 28 days after dose 3 | |
Secondary | Immunogenicity: Geometric Mean Titers Before 6-month Booster | Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B | Before 6-month booster | |
Secondary | Immunogenicity: Geometric Mean Titers at 12 Months | Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B. | at 12 months | |
Secondary | Immunogenicity: Geometric Mean Titers After 6-month Booster | Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B. | month 6 after dose 4 |
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