MedTrace Logo

TDENV PIV and LAV Dengue Prime-boost Strategy

NCT02239614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-08-15

No results posted yet for this study

Summary

The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with alum and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TDENV-LAV

0.5 mL of the post-transfection LAV F17 vaccine

BIOLOGICAL

TDENV-PIV 4 µg + alum adjuvant

0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • MAJ Leyi Lin, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-02-17
Completion
2017-02-17

Countries

  • United States

Study Locations

More Related Trials

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 NCT02239614 on ClinicalTrials.gov