NCT01702857

A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico)

A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of WRAIR Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in Puerto Rico

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 20 Years – 39 Years
• Healthy volunteers: Accepted

Summary

This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV vaccine in a predominantly dengue-primed adult population. The study is designed to afford a first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally, the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per each of the four DENV types. The control group will receive a saline placebo. All experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart. There is a parallel FTiH study that is conducted in the United States in a dengue-naive population using the same investigational vaccines.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant
BIOLOGICAL	Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant
OTHER	Phosphate buffered saline
BIOLOGICAL	1 µg TDENV-PIV with Alum adjuvant
BIOLOGICAL	1 µg TDENV-PIV with AS01E adjuvant

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-01-20
• Completion: 2017-03-23
• First posted: 2012-10-10
• Last updated: 2017-05-23

Locations

1 site across 1 country: Puerto Rico