At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 target
Drug / intervention
rDEN1delta30 +1 morebiological
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.
Safety and Immunogenicity of a 2-Dose Regimen of rDEN1delta30 Dengue Serotype 1 Vaccine With Boosting at 4 Versus 6 Months
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 14, 2007·Updated Jan 13, 2010
In Brief
A Phase 1 clinical trial evaluating rDEN1delta30 and Placebo for Dengue. Completed, enrolled 60 participants across 1 site.
Detailed Summary
Dengue fever, caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety of and immune response to a 2-dose regimen of a new monovalent dengue virus vaccine. This study will test the dengue virus vaccine DEN1delta30 in healthy adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesUnited States
CollaboratorsJohns Hopkins Bloomberg School of Public Health
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedMay 2007
Primary CompletionJan 2010
TodayJul 2026
First PostedMay 14, 2007
Enrollment StartMay 1, 2007
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.1 years ago
Interventions
rDEN1delta30biological
Live attenuated rDEN1delta30 vaccine at a dose of 10\^3 PFU
Placebobiological
Placebo for rDEN1delta30