RVF
A Phase 2 Open Label Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated, Dried, TSI-GSD 200, Lot 7, Run 2, in Adult Subjects at Risk of Exposure to Rift Valley Fever Virus
Sponsor study identifier
interventional
500
1 country
1
Study Start
October 4, 2018
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 24, 2018
Actual (reported)August 1, 2018
Actual (reported)October 4, 2018
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine
Safety assess of local and systemic adverse events and their relationship to the study vaccine. AEs will be recorded for 28 days after each dose of the vaccine for the assessment population (all subjects who receive at least one vaccination under this protocol. Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
0-28 days after each dose
Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects
Percentage of per-protocol subjects (subjects who adhered to the protocol schedule for both vaccination and blood collects) who developed titers ≥1:40 as determined by PRNT80 (plaque reduction neutralization 80% titer) after vaccination at each scheduled time point for which blood samples are drawn and over the entire study period.
21-35 days after each vaccination and month 12
Frequency and Severity of Adverse Events
0-28 days after each dose
Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects
21-35 days after each vaccination and month 12
Geometric Mean PRNT50 (plaque reduction neutralization 50% titer) of Per-protocol Subjects
21-35 days after each vaccination and month 12
1.0 mL dose given SQ in upper arm
1.0 mL dose given SQ in upper arm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Special Immunization Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, 21702, United States
First Submitted
July 24, 2018
First Posted
August 1, 2018
Study Start
October 4, 2018
Actual (reported)Primary Completion
December 2023
Rift Valley Fever in Kenya
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 11, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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