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Tetravalent Chimeric Dengue Vaccine Trial

NCT01110551 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-02-04

No results posted yet for this study

Summary

The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of 18-45 years old will be enrolled in this research study at Saint Louis University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study procedures include: maintaining a diary to record temperature and side effects, physical exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples. Participants will be involved in study related procedures for about 10 months.

Conditions

  • Dengue

Interventions

DRUG

Placebo (SC)

Phosphate buffered saline administered subcutaneously.

DRUG

Placebo (ID)

Phosphate buffered saline administered intradermally.

BIOLOGICAL

Modified Live Tetravalent Chimeric Dengue Vaccine (SC)

DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera (DENVax-3) and DEN-2/4 chimera (DENVax-4). The drug product is formulated in buffer and stored frozen. Low dose contains (dose volume 0.1 mL): D1: 8 x 10\^3, D2: 5 x 10\^3, D3: 1 x 10\^4, and D4: 2 x 10\^5, total virus dose \[plaque forming units (PFU)\]: 2.2 x 10\^5. High dose contains (dose volume 0.1 mL): D1: 2 x 10\^4, D2: 5 x 10\^4, D3: 1 x 10\^5, and D4: 3 x 10\^5, total virus dose (PFU): 4.7 x 10\^5. DENVax administered subcutaneously.

BIOLOGICAL

Modified Live Tetravalent Chimeric Dengue Vaccine (ID)

DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera (DENVax-3) and DEN-2/4 chimera (DENVax-4). The drug product is formulated in buffer and stored frozen. Low dose contains (dose volume 0.1 mL): D1: 8 x 10\^3, D2: 5 x 10\^3, D3: 1 x 10\^4, and D4: 2 x 10\^5, total virus dose \[plaque forming units (PFU)\]: 2.2 x 10\^5. High dose contains (dose volume 0.1 mL): D1: 2 x 10\^4, D2: 5 x 10\^4, D3: 1 x 10\^5, and D4: 3 x 10\^5, total virus dose (PFU): 4.7 x 10\^5. DENVax administered intradermally.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-04-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT01110551 on ClinicalTrials.gov