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

NCT01702857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-05-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Clemente Diaz, MD · University of Puerto Rico

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-01-20
Completion
2017-03-23

Countries

  • Puerto Rico

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01702857 on ClinicalTrials.gov