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Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age

NCT02879266 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-04-02

No results posted yet for this study

Summary

This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TetraVax-DV TV005

Contains 10\^3 plaque-forming units (PFUs) of rDEN1Δ30, 10\^4 PFUs of rDEN2/4Δ30(ME), 10\^3 PFUs of rDEN3Δ30/31-7164, and 10\^3 PFUs of rDEN4Δ30; 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

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2017-09-07

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 NCT02879266 on ClinicalTrials.gov