CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
rDEN1delta30 +2 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.

Search/NCT00458120
NCT00458120Phase 1Completed
CompareCT.gov

Evaluation of the Safety and Immunogenicity of Heterologous Dengue Vaccine Administration in Dengue Immune Individuals

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 9, 2007·Updated Dec 14, 2010

In Brief

A Phase 1 clinical trial evaluating rDEN1delta30, rDEN2/4delta30(ME), and 1 other intervention for Dengue Hemorrhagic Fever. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause dengue fever. The purpose of this study is to determine the safety and immune response to a vaccine containing a particular dengue serotype when an individual has been previously vaccinated with a different dengue serotype.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Hemorrhagic Fever
CountriesUnited States
CollaboratorsJohns Hopkins Bloomberg School of Public Health

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.2 years ago

Interventions

rDEN1delta30biological

Live attenuated 10\^3 dose of rDEN1delta30 vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN2/4delta30(ME) vaccines.

rDEN2/4delta30(ME)biological

Live attenuated 10\^3 dose of rDEN2/4delta30(ME) vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN1delta30 vaccines.

Placebo to rDEN1delta30 or rDEN2/4delta30(ME)biological

Placebo vaccines for rDEN1delta30 and rDEN2/4delta30(ME)