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

This study is currently recruiting participants.
Verified August 2012 by U.S. Army Medical Research and Materiel Command
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: August 3, 2012
Last verified: August 2012
History of Changes
  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:

MedlinePlus related topics: Fever Valley Fever
U.S. FDA Resources

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

Primary Outcome Measures:
  • Safety: The nature and frequency of adverse events for the assessment population, on a per dose basis. Immunogenicity: 80% plaque reduction neutralization 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
primary vaccination with boost
None
 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:

Study Objectives:

Primary:

  1. To assess safety of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200)
  2. To assess immunogenicity of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200).

Secondary:

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 actively enrolled in the SIP at USAMRIID,
  5. Subject must be at risk for exposure to RVF virus,
  6. 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 may be repeated within 1 year at the discretion of the enrolling physician,
  7. Subject must sign and date the approved informed consent document,
  8. 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. History of immunodeficiency or current treatment with immunosuppressive medication.
  4. Confirmed 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

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

Contacts
Contact: Fernando Guerena, MD 301-619-6682 fernando.guerena@amedd.army.mil

Locations
United States, Maryland
U.S. Army Medical Research Institute of Infectious Diseases Recruiting
Fort Detrick, Maryland, United States, 21702
Contact: Fernando Guerena, MD     301-619-6682     fernando.guerena@us.army.mil    
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Fernando Guerena, 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: Log A-15322, FY08-07
Study First Received: March 25, 2009
Last Updated: August 3, 2012
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:
Hemorrhagic Fevers, Viral
Coccidioidomycosis
Coccidiosis
Fever
Rift Valley Fever
Mycoses
Protozoan Infections
Parasitic Diseases
Body Temperature Changes
Signs and Symptoms
 Arbovirus Infections
Virus Diseases
Hepatitis, Viral, Animal
Bunyaviridae Infections
RNA Virus Infections
Hepatitis, Animal
Hepatitis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013