Safety and Immunogenicity Study of Rift Valley Fever Vaccine - Full Text View

Purpose

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

Condition	Intervention	Phase
Rift Valley Fever	Biological: TSI-GSD 200 RVF Vaccine	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Fever Valley Fever

Genetic and Rare Diseases Information Center resources: Hemorrhagic Fever Viral Hemorrhagic Fever Coccidioidomycosis

U.S. FDA Resources

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:

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:

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)
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
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.
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.


Enrollment:	278
Study Start Date:	June 2004
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584194

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


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 )
Study First Received:	December 20, 2007
Results First Received:	February 22, 2017
Last Updated:	June 16, 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

ClinicalTrials.gov processed this record on September 25, 2017

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