Clinical trial NCT00584194: Safety and Immunogenicity Study of Rift Valley Fever Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rift Valley Fever
Keywords: Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2008-01-02
Enrollment: 278
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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 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 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.

Primary outcomes:
measure: Safety: All Incidences of Erythema
timeFrame: 12 months
Secondary outcomes:
measure: Immunogenicity: Geometric Mean Titers After 3rd Vaccination
timeFrame: 28 days after dose 3
measure: Immunogenicity: Geometric Mean Titers Before 6-month Booster
timeFrame: Before 6-month booster
measure: Immunogenicity: Geometric Mean Titers at 12 Months
timeFrame: at 12 months
measure: Immunogenicity: Geometric Mean Titers After 6-month Booster
timeFrame: month 6 after dose 4
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: U.S. Army Medical Research Institute of Infectious Diseases
state: Maryland
Study officials:
affiliation: USAMRIID Medical Division
name: Janice Rusnak, MD
role: PRINCIPAL_INVESTIGATOR
References: