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Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2

NCT02433652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-02-28

No results posted yet for this study

Summary

Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6 months after the trivalent dengue vaccine.

Conditions

  • Dengue

Interventions

BIOLOGICAL

Recombinant live attenuated trivalent dengue vaccine

Contains 10\^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10\^3.3 PFU/mL of rDEN3Δ30/31-7164 and 10\^3.3 PFU/mL of rDEN4Δ30. It is administered in 0.5 mL containing 10\^3.0 PFU of each component.

BIOLOGICAL

Placebo

BIOLOGICAL

rDEN2Δ30-7169 vaccine

Live recombinant attenuated DENV-2 candidate vaccine virus; will be administered at a dose of 10\^3 PFU

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anna Durbin, MD · Center for Immunization Research (CIR), Johns Hopkins School of Public Health

  • Kristen Pierce, MD · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-11-30

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02433652 on ClinicalTrials.gov