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Evaluating the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30

NCT02873260 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-03-08

No results posted yet for this study

Summary

This study will evaluate the ability of a single dose of the live attenuated recombinant tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005 vaccine.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TetraVax-DV-TV005

TetraVax-DV-TV005 contains 10\^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10\^4.3 PFU/mL of rDEN2/4Δ30(ME), 10\^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10\^3.3 PFU/mL of rDEN4Δ30. The vaccine is administered in 0.5 mL containing 10\^3.0 PFU of each component with the exception of rDEN2/4Δ30 that is given at a dose of 10\^4 PFU. TetraVax-DV-TV005 is administered by subcutaneous injection in the deltoid region of the upper arm.

BIOLOGICAL

rDEN3Δ30

Administered at a dose of 10\^4 PFU by subcutaneous injection in the deltoid region of the upper arm.

BIOLOGICAL

Placebo

Administered at a volume of 0.5 mL 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
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-11-30
Completion
2017-11-30

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 NCT02873260 on ClinicalTrials.gov