Clinical Trials Directory

Trials / Completed

CompletedNCT01666652

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

A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of Walter Reed Army Institute of Research (WRAIR) Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in a Non-Endemic Region

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

Summary

The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.

Detailed description

The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or AS03B (adjuvants used in Glaxo Smith Kline (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.

Conditions

Interventions

TypeNameDescription
BIOLOGICAL4 µg TDENV-PIV with Alum adjuvant
BIOLOGICAL1 µg TDENV-PIV with AS03B1 adjuvant
OTHERPhosphate buffered saline
BIOLOGICAL1 µg TDENV-PIV with Alum adjuvant
BIOLOGICAL1 µg TDENV-PIV with AS01E1 adjuvant

Timeline

Start date
2012-09-01
Primary completion
2015-09-01
Completion
2017-11-01
First posted
2012-08-16
Last updated
2019-01-25
Results posted
2019-01-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01666652. Inclusion in this directory is not an endorsement.