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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00869713
First received: March 25, 2009
Last updated: April 10, 2015
Last verified: April 2015

March 25, 2009
April 10, 2015
June 2009
June 2016   (final data collection date for primary outcome measure)
  • PRNT80 ≥ 1:40 after primary series [ Time Frame: Between Days 28-42 ] [ Designated as safety issue: No ]
    % vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
  • PRNT80 ≥ 1:40 after 6-month mandatory booster dose [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    % vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
  • (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    % initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.
  • Median duration of PRNT80 ≥ 1:40 in initial responders [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
  • Median duration of PRNT80 ≥ 1:40 in initial non-responders [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.
  • Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40 [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.
Safety: The nature and frequency of adverse events for the assessment population, on a per dose basis. Immunogenicity: 80% plaque reduction nuetralization assay (PRNT80). [ Time Frame: AEs: recorded through day 28 after each dose; SAEs: duration of study; Immunogenicity: PRNT80 at 21-35 days after each primary or booster dose, and annually. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00869713 on ClinicalTrials.gov Archive Site
  • Subjects without symptoms [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Subjects with any category of local reaction (grade 1-4). [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4). [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Subjects with generalized allergic reactions [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Immunogenicity: Documented occurrence of Rift Valley fever following exposure to RVF virus in a vaccinated individual. [ Time Frame: Entire length of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated
Long-Term Open-Label Primary Vaccination and Booster Dose Study of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) in At-Risk Adults

This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults

The primary objectives are to assess safety of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and to assess immunogenicity of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200). The secondary objective is to assess incidence of RVF infection in vaccinated 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
All subjects: 1.0-mL (SQ)doses on day 0, once between days 7 & 14, & once between days 28-42. Initial responders: A 6-month mandatory vaccine booster dose (1.0 mL, SQ) will be given if the PRNT80 is ≥1:40 after the primary series. Subsequent booster doses will be given for PRNT80 titer <1:40. Initial non-responders: Individual who has a PRNT80 titer <1:40 following the primary series may be administered a booster dose before 6 months. The individual will not receive the mandatory 6-month booster dose. Once an initial non-responder achieves PRNT80 ≥1:40, additional booster doses will be given for subsequent PRNT80 <1:40). All subjects: RVF booster dose will be administered within 90 days after a PRNT80 result of <1:40.
primary vaccination with boost
Inactivated, Dried (TSI-GSD 200), RVF Vaccine
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.
 
Enrolling by invitation
500
June 2017
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At least 18 years old.
  2. Females of childbearing potential must have a negative serum or urine pregnancy test within 48 hours before each vaccination. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose.
  3. Females must not be breast-feeding.
  4. Subject must be at risk for exposure to RVF virus.
  5. Subject 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 to qualify for enrollment may be repeated at the discretion of the investigators.
  6. Subject must sign and date the approved informed consent document.
  7. For initiation of primary series, RVF PRNT80 <1:10.
  8. For RE-ENTRY into this protocol or ROLLOVER from an earlier RVF protocol to receive a booster, RVF PRNT80 <1:40 within past 1 year

Exclusion Criteria:

  1. Older than 65 years of age for the primary series vaccination (able to receive booster doses if no other contraindications).
  2. Clinically significant abnormal lab results, including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2 times normal) liver function tests.
  3. Personal history of immunodeficiency or current treatment with immunosuppressive medication.
  4. Confirmed positive human immunodeficiency virus (HIV) titer.
  5. Any medical condition that, at the discretion of the physician, may jeopardize the safety of the subject.
  6. Any serious or life-threatening allergies to any component of the vaccine: formalin human serum albumin neomycin streptomycin fetal rhesus lung cells RVF virus inactivated
  7. Administration of any Investigational New Drug (IND) product or any vaccine within the 28 days before RVF vaccination.
  8. Any unresolved adverse event resulting from a previous immunization.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00869713
A-15322, FY08-07
No
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
Not Provided
Principal Investigator: Matthew Chambers, MD USAMRIID Medical Division
U.S. Army Medical Research and Materiel Command
April 2015

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