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Evaluation of the Safety and Immune Response of Five Admixtures of a Tetravalent Dengue Virus Vaccine

NCT01072786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2013-01-03

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 of five formulations of a tetravalent dengue virus vaccine in healthy adults.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TetraVax-DV Vaccine-Admixture 1

One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 1 (10\^3 PFU of rDEN1Δ30, 10\^3 PFU of rDEN2/4Δ30\[ME\], 10\^3 PFU of rDEN3-3´D4Δ30, 10\^3 PFU of rDEN4Δ30)

BIOLOGICAL

TetraVax-DV Vaccine-Admixture 2

One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 2 (10\^3 PFU of rDEN1Δ30, 10\^3 PFU of rDEN2/4Δ30\[ME\], 10\^3 PFU of rDEN3-3´D4Δ30, 10\^3 PFU of rDEN4Δ30-200,201)

BIOLOGICAL

TetraVax-DV Vaccine-Admixture 3

One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 3 (10\^3 PFU of rDEN1Δ30, 10\^3 PFU of rDEN2/4Δ30\[ME\], 10\^3 PFU of rDEN3Δ30/31-7164, 10\^3 PFU of rDEN4Δ30)

BIOLOGICAL

TetraVax-DV Vaccine-Admixture 4

One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 4 (10\^3 PFU of rDEN1Δ30, 10\^3 PFU of rDEN2/4Δ30\[ME\], 10\^3 PFU of rDEN3Δ30/31-7164, 10\^3 PFU of rDEN4Δ30-200,201)

BIOLOGICAL

Placebo

One subcutaneous injection of a placebo containing vaccine diluent but no actual vaccine

BIOLOGICAL

TetraVax-DV Vaccine-Admixture 5

One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 5 (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)

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • 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
2010-07-31
Primary Completion
2012-06-30
Completion
2012-06-30

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 NCT01072786 on ClinicalTrials.gov