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Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine

NCT02684383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-11-30

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 safety and immunogenicity of a live attenuated monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous flavivirus infection.

Conditions

  • Dengue

Interventions

BIOLOGICAL

rDEN3∆30

10\^3 plaque-forming units (PFUs); administered by subcutaneous injection in the deltoid region of the upper arm

BIOLOGICAL

Placebo

Administered by subcutaneous injection in the deltoid region of the upper arm

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • 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

Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02684383 on ClinicalTrials.gov