Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Immunogenicity Study of Rift Valley Fever Vaccine (RVF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00584194
First received: December 20, 2007
Last updated: November 7, 2014
Last verified: November 2014

December 20, 2007
November 7, 2014
June 2004
May 2010   (final data collection date for primary outcome measure)
Immunogenicity [ Time Frame: 28 days after dose 3, pre-6-month dose and 12 month titer ] [ Designated as safety issue: No ]
Measurement is the 80% plaque-reduction neutralization titer (PRNT80). Subjects who were non-responders to the primary series and subsequently received boosters
Safety: The frequency of adverse events in this RVF vaccine study will be evaluated for all intent-to-treat subjects; Immunogenicity: Measurement is the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs: recorded through day 28 after each dose; SAEs: duration of study; Immunogenicity: PRNT80 at 28 days after dose 3. Part B: Pre-6-month dose and 12 month titer. Any RVF illness in a vaccinated subject will be recorded for duration of study. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00584194 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Rift Valley Fever
Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Part A: 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.
No Intervention: no arms
no arms
Intervention: Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
May 2010
May 2010   (final data collection date for primary outcome measure)

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.

Both
17 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584194
A-12592, FY03-05
No
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
Not Provided
Principal Investigator: Janice Rusnak, MD USAMRIID Medical Division
U.S. Army Medical Research and Materiel Command
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP