NCT00468858

A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

Phase II, Randomized, Double-blind, Placebo-controlled Study of Two Doses of WRAIR Live Attenuated Tetravalent Dengue Vaccine Formulations, Administered Six Months Apart, to Healthy Adults and Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 636 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 12 Months – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two doses are given six months apart to adults and children.

Detailed description

In this study, children and adults at multiple sites in Puerto Rico will be randomly allocated to receive one of two T-DEN formulations or placebo. Subjects will be stratified by age group (a specific number of subjects in each of 4 age groups \[12 months to 50 years of age\] will be enrolled). The study includes 6 scheduled visits and 4 scheduled venipunctures. Safety follow-up for dengue may require unscheduled visits and venipunctures.\> Multiple DEN virus serotypes are endemic in Puerto Rico and all residents are considered to be at risk for dengue. The results of this phase II study will provide a basis for identifying the vaccine formulations which elicit neutralizing antibodies to all four dengue virus serotypes in a high proportion of vaccine recipients. The most immunogenic and well tolerated candidate formulation identified in this study will be considered for advancement to phase III development.\>

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever
• Dengue Shock Syndrome

Interventions

Type	Name	Description
OTHER	Placebo	Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months
BIOLOGICAL	T-DEN-Post-Transfection F17	Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
BIOLOGICAL	T-DEN-Post-Transfection F19	Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-05-03
• Last updated: 2017-07-02
• Results posted: 2017-06-06

Locations

11 sites across 1 country: Puerto Rico