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: June 21, 2013
Last verified: June 2013
  Purpose

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


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: Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 278
Study Start Date: June 2004
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no arms
no arms
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  • 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.

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.
  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: NCT00584194

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: Janice Rusnak, MD USAMRIID Medical Division
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00584194     History of Changes
Other Study ID Numbers: A-12592, FY03-05
Study First Received: December 20, 2007
Last Updated: June 21, 2013
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
Mycoses
Protozoan Infections
Parasitic Diseases
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Hepatitis, Viral, Animal
Bunyaviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Hepatitis, Animal
Hepatitis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014