CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 278 enrolled
Drug / intervention
TSI-GSD 200 RVF Vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00584194
NCT00584194Phase 2Completed
CompareCT.gov

Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study

U.S. Army Medical Research and Development Command·interventional·Posted Jan 2, 2008·Updated Jan 3, 2020

In Brief

A Phase 2 clinical trial evaluating TSI-GSD 200 RVF Vaccine for Rift Valley Fever. Completed, enrolled 278 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRift Valley Fever
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2, 2008
Enrollment StartJun 1, 2004
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 18.5 years ago

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.