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

United States Army Medical Research and Development Command (USAMRDC)

Status and phase: Completed; Phase 2

Conditions: Rift Valley Fever

Treatments: Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00869713

FY08-07 (Other Identifier)

A-15322

Details and patient eligibility

About

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

Full 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

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

primary vaccination with boost

Other group

Description:

Inactivated, Dried (TSI-GSD 200), RVF Vaccine

Treatment:

Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine