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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Rift Valley Fever	Biological: TSI-GSD 200 RVF Vaccine	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	278 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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 Start Date :	June 2004
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	May 2010

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. Safety: All Incidences of Erythema [ Time Frame: 12 months ]
   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 :

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

Eligibility Criteria

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Ages Eligible for Study:	17 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:	Janice Rusnak, MD	USAMRIID Medical Division

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00584194 History of Changes
Other Study ID Numbers:	A-12592; FY03-05 ( Other Identifier: SIP )
First Posted:	January 2, 2008
Results First Posted:	July 14, 2017
Last Update Posted:	July 14, 2017
Last Verified:	June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by U.S. Army Medical Research and Materiel Command:

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

Additional relevant MeSH terms:

Fever; Coccidioidomycosis; Coccidiosis; Rift Valley Fever; Body Temperature Changes; Signs and Symptoms; Mycoses; Protozoan Infections; Parasitic Diseases; Arbovirus Infections; Virus Diseases	Hepatitis, Viral, Animal; Bunyaviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Hepatitis, Animal; Hepatitis; Liver Diseases; Digestive System Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs