Trials Sponsors Conditions Drugs Pricing

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 VaccineBiological

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age17 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (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,

Sponsors & Collaborators

U.S. Army Medical Research and Development Command
US federal agencylead

Study Sites (1)

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

MeSH Terms

Conditions

Rift Valley FeverHemorrhagic Fevers, ViralVirus DiseasesNervous System DiseasesArbovirus Infections

Condition Hierarchy (Ancestors)

Hepatitis, Viral, AnimalHepatitis, AnimalInfectionsMosquito-Borne DiseasesVector Borne DiseasesBunyaviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title: Janice Rusnak, MD
Organization: USAMRIID Medical Division

Study Officials

Janice Rusnak, MD
USAMRIID Medical Division
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

278 participants (actual enrollment reported by the registry).

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 2004

Actual (reported)

Primary Completion

Safety and Immunogenicity Study of Rift Valley Fever Vaccine

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

TSI-GSD 200 RVF Vaccine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

TSI-GSD 200 RVF Vaccine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations