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Evaluating the Safety and Immune Response to Two Admixtures of a Tetravalent Dengue Virus Vaccine

NCT01506570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-08-20

No results posted yet for this study

Summary

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy adults who have previously been infected with a dengue virus or other flavivirus or have previously received a flavivirus vaccine.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TetraVax-DV Vaccine - Admixture TV003

One SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV003 (10\^3 plaque-forming unit \[PFU\] of rDEN1Δ30, 10\^3 PFU of rDEN2/4Δ30\[ME\], 10\^3 PFU of rDEN3Δ30/31-7164, and 10\^3 PFU of rDEN4Δ30)

BIOLOGICAL

TetraVax-DV Vaccine - Admixture TV005

One SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV005 (10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30\[ME\], 10\^3 PFU of rDEN3Δ30/31-7164, and 10\^3 PFU of rDEN4Δ30)

BIOLOGICAL

Placebo

One SC injection at Day 0 and Day 180 of placebo

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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-09-30
Completion
2013-09-30

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 NCT01506570 on ClinicalTrials.gov