NCT00370682

A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand

Phase II, Randomized, Double-blind, Single Center, Controlled Study of Two Doses of Different Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control, Administered on a 0-6 Month Schedule, to Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 20 Years – 25 Years
• Healthy volunteers: Accepted

Summary

This descriptive study will evaluate the safety and immunogenicity of different formulations of the WRAIR dengue vaccine compared to a placebo.

Detailed description

Subjects will be randomized into one of three groups. One group will receive a placebo vaccine and the other two will receive different dengue vaccine formations. Each subject will receive two doses six months apart. All subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	T-DEN F17	A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
BIOLOGICAL	T-DEN F-19	A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
OTHER	Placebo Comparator	A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-09-01
• Last updated: 2017-05-30
• Results posted: 2017-05-30

Locations

1 site across 1 country: Thailand

Regulatory

• FDA-regulated drug study