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Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inviragen Inc.
ClinicalTrials.gov Identifier:
NCT01511250
First received: November 16, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and tolerability of a dengue vaccine administered subcutaneously in healthy adults and children. In addition the antibody response to the four dengue virus serotypes will be evaluated.


Condition Intervention Phase
Healthy
 Biological: DENVax
Biological: Phosphate buffered saline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Age Descending and Expansion Phase 2 Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years

Resource links provided by NLM:

MedlinePlus related topics: Dengue
U.S. FDA Resources

Further study details as provided by Inviragen Inc.:

Primary Outcome Measures:
  • Local Injection site reactions to a dengue vaccine administered subcutaneously [ Time Frame: 30 days post dose ] [ Designated as safety issue: Yes ]
    Local injection site reactions that measure erythema (rash), edema, pain and itching will be evaluated. Active vaccine will be compared to placebo.

  • Systemic reactions to a dengue vaccine administered subcutaneously [ Time Frame: up to Day 120 ] [ Designated as safety issue: Yes ]
    Systemic reactions, including fever and rash, will be evaluated in subjects receiving dengue vaccine and compared to subjects receiving placebo.


Secondary Outcome Measures:
  • Neutralizing Antibody titers of a dengue vaccine against four serotypes of dengue virus [ Time Frame: 30 days post dose 2 ] [ Designated as safety issue: No ]
    Neutralizing antibody titers (at Day 120) will be compared to baseline (day 0) titers.


Estimated Enrollment: 344
Study Start Date: November 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Phosphate buffered saline Biological: Phosphate buffered saline
placebo control
Experimental: DENVax
Live attenuated experimental Dengue vaccine
 Biological: DENVax
live attenuated Dengue vaccine, 0.5 ml dose subcutaneously administered at Day 0 and Day 90

  Eligibility

Ages Eligible for Study:   18 Months to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health
  • Normal laboratory values at screening

Exclusion Criteria:

  • Abnormal ECG
  • History of significant dermatologic (skin) disease within last 6 months
  • Diabetes mellitus
  • History of any immunodeficiency
  • History of recurring headaches or migraines
  • Hypersensitivity to vaccines
  • Use of amphetamines, opiates, cannabinoids
  • History of alcohol abuse
  • Pregnant or lactating female
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511250

Locations
Colombia
Universidad de Antiquia, PECET
Medillin, Colombia
Puerto Rico
Ponce School of Medicine, CAIMED Center
Ponce, Puerto Rico, 00716
Latin Clinical Trial Center
San Juan, Puerto Rico, 00909
University of Puerto Rico, School of Medicine
San Juan, Puerto Rico, 00936
Singapore
National University Hospital, Department of Pediatrics
Singapore, Singapore, 119074
Changi General Hospital 2
Singapore, Singapore, 529889
Thailand
Mahidol University
Bangkok, Thailand, 10400
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Inviragen Inc.
Investigators
Study Chair: Gilad Gordon, MD Inviragen Inc.
  More Information

No publications provided

Responsible Party: Inviragen Inc.
ClinicalTrials.gov Identifier: NCT01511250     History of Changes
Other Study ID Numbers: INV-DEN-203
Study First Received: November 16, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Singapore: Health Sciences Authority
Thailand: Ministry of Public Health

Keywords provided by Inviragen Inc.:
normal healthy adults and children
Safety and tolerability
active vaccine
 placebo
Dengue virus vaccine
Immune response

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
 Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on May 23, 2013