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
  Purpose

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


Condition Intervention Phase
Rift Valley Fever
Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: June 2009
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
primary vaccination with boost
Inactivated, Dried (TSI-GSD 200), RVF Vaccine
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869713

Locations
United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases
Fort Detrick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Matthew Chambers, MD USAMRIID Medical Division
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00869713     History of Changes
Other Study ID Numbers: A-15322, FY08-07
Study First Received: March 25, 2009
Last Updated: April 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Hemorrhagic Fever
Viral Infections
Neurologic diseases
Arbovirus Infections
RVF

Additional relevant MeSH terms:
Coccidioidomycosis
Coccidiosis
Fever
Rift Valley Fever
Arbovirus Infections
Body Temperature Changes
Bunyaviridae Infections
Digestive System Diseases
Hemorrhagic Fevers, Viral
Hepatitis
Hepatitis, Animal
Hepatitis, Viral, Animal
Liver Diseases
Mycoses
Parasitic Diseases
Protozoan Infections
RNA Virus Infections
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on July 27, 2015