Back to results

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

Primary Purpose

Rift Valley Fever

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TSI-GSD 200 RVF Vaccine

About this trial

This is an interventional prevention trial for Rift Valley Fever focused on measuring Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

U.S. Army Medical Research Institute of Infectious Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TSI-GSD 200 RVF Vaccine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Immunogenicity: Geometric Mean Titers Before 6-month Booster

Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B

Immunogenicity: Geometric Mean Titers at 12 Months

Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.

Immunogenicity: Geometric Mean Titers After 6-month Booster

Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.

Full Information

NCT ID

NCT00584194

First Posted

December 20, 2007

Last Updated

December 30, 2019

Sponsor

U.S. Army Medical Research and Development Command

1. Study Identification

Unique Protocol Identification Number

NCT00584194

Brief Title

Safety and Immunogenicity Study of Rift Valley Fever Vaccine

Acronym

RVF

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

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

June 2004 (Actual)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rift Valley Fever

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

278 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TSI-GSD 200 RVF Vaccine

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

TSI-GSD 200 RVF Vaccine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety: All Incidences of Erythema

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Immunogenicity: Geometric Mean Titers After 3rd Vaccination

Description

Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)

Time Frame

28 days after dose 3

Title

Immunogenicity: Geometric Mean Titers Before 6-month Booster

Description

Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B

Time Frame

Before 6-month booster

Title

Immunogenicity: Geometric Mean Titers at 12 Months

Description

Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.

Time Frame

at 12 months

Title

Immunogenicity: Geometric Mean Titers After 6-month Booster

Description

Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.

Time Frame

month 6 after dose 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janice Rusnak, MD

Organizational Affiliation

USAMRIID Medical Division

Official's Role

Principal Investigator

Facility Information:

Facility Name

U.S. Army Medical Research Institute of Infectious Diseases

City

Fort Deterick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Immunogenicity Study of Rift Valley Fever Vaccine

We'll reach out to this number within 24 hrs