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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial Summary

This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine


Description:

Study Objectives:

The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
TSI-GSD 200 RVF Vaccine
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 = 1:40 or annually if titer wanes to < 1:40.

Locations

Country Name City State
United States U.S. Army Medical Research Institute of Infectious Diseases Fort Deterick Maryland

Sponsors (1)

Lead Sponsor Collaborator
U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Completed NCT00869713 - Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated Phase 2
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Recruiting NCT03609398 - Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine Phase 2
Completed NCT04672824 - A Study to Assess the New Candidate Rift Valley Fever Virus Vaccine in Healthy Adults Phase 1
Completed NCT00287014 - Rift Valley Fever in Kenya N/A
Completed NCT04754776 - Safety and Immunogenicity of a Candidate RVFV Vaccine (RVF001) Early Phase 1
Completed NCT00415051 - Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine Phase 2