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

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

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

Study Overview

• Status: Completed
• Conditions: Rift Valley Fever
• Intervention / Treatment: Biological: TSI-GSD 200 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.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Fort Deterick, Maryland, United States, 21702
      • U.S. Army Medical Research Institute of Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TSI-GSD 200 RVF Vaccine; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity: Geometric Mean Titers After 3rd Vaccination	Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)	28 days after dose 3
Immunogenicity: Geometric Mean Titers Before 6-month Booster	Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B	Before 6-month booster
Immunogenicity: Geometric Mean Titers at 12 Months	Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.	at 12 months
Immunogenicity: Geometric Mean Titers After 6-month Booster	Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.	month 6 after dose 4

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Janice Rusnak, MD, USAMRIID Medical Division

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2004
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 31, 2007
• First Posted (Estimate): January 2, 2008

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Arbovirus Infections; Vector Borne Diseases; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Mycoses; Body Temperature Changes; Hemorrhagic Fevers, Viral; Hepatitis; Bunyaviridae Infections; Hepatitis, Viral, Animal; Hepatitis, Animal; Fever; Coccidioidomycosis; Coccidiosis; Rift Valley Fever
• Other Study ID Numbers: A-12592; FY03-05 (Other Identifier: SIP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No