Safety and Immunogenicity Study of Rift Valley Fever Vaccine

NCT00584194 | Completed Phase 2 Results

• 2 other identifiers: A-12592FY03-05
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rift Valley Fever

Keywords

Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF

Outcome Measures

Primary Outcomes (1)

• Safety: All Incidences of Erythema

  Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study

  12 months

Secondary Outcomes (4)

• Immunogenicity: Geometric Mean Titers After 3rd Vaccination

  28 days after dose 3

• Immunogenicity: Geometric Mean Titers Before 6-month Booster

  Before 6-month booster

• Immunogenicity: Geometric Mean Titers at 12 Months

  at 12 months

• Immunogenicity: Geometric Mean Titers After 6-month Booster

  month 6 after dose 4

Study Arms (1)

TSI-GSD 200 RVF Vaccine

EXPERIMENTAL

Part A: Inactivated, Dried (TSI-GSD 200) 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.

Biological: TSI-GSD 200 RVF Vaccine

Interventions

TSI-GSD 200 RVF Vaccine BIOLOGICAL

Part A: Inactivated, Dried (TSI-GSD 200) 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.

TSI-GSD 200 RVF Vaccine

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Completion of primary series and any follow-up titer (PRNT80) \< 1:40 from the current or a previous RVF IND 365 protocol.

You may not qualify if:

• 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.
• An adequate PRNT80 (≥ 1:40) after completion of primary series.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Rift Valley Fever; Hemorrhagic Fevers, Viral; Virus Diseases; Nervous System Diseases; Arbovirus Infections

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Animal; Hepatitis, Animal; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Bunyaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Animal Diseases

Results Point of Contact

• Title: Janice Rusnak, MD
• Organization: USAMRIID Medical Division

janice.rusnak@amedd.army.mil

301-619-4156

Study Officials

• Janice Rusnak, MD

  USAMRIID Medical Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: June 1, 2004
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 3, 2020
• Results First Posted: July 14, 2017

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)