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Safety Study of a Dengue Virus DNA Vaccine

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00290147
First received: February 9, 2006
Last updated: June 26, 2009
Last verified: June 2009
History of Changes
  Purpose

The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.


Condition Intervention Phase
Dengue
 Biological: D1ME (dengue-1 premembrane/envelope DNA vaccine)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Clinical Trial of a Dengue-1 DNA Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Dengue
U.S. FDA Resources

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Safety and reactogenicity as evaluated by clinical visits and safety labs.

Secondary Outcome Measures:
  • Measurement of anti-dengue antibody and T cell responses.

Estimated Enrollment: 24
Study Start Date: January 2006
Study Completion Date: April 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Dengue is a desease that affects 100 million people throughout the world mainly in tropical countries in the South Pacific, Asia, the Caribbean, and Africa. The disease often presents with high fever, severe headache, and joint/muscle pain that usually goes away on its own, but it can also present as a sometimes deadly hemorrhagic (bleeding) disease. Humans catch this disease by being bitten by mosquitoes that have been infected with dengue virus. Scientists at the Naval Medical Research Center have been working on vaccines to prevent dengue disease. This vaccine, referred to as D1ME, is an experimental DNA vaccine that contains genes from the dengue-1 virus. The purpose of this study is to test the safety of a new experimental vaccine against dengue and to see if the vaccine can stimulate the immune system.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Available to participate for the duration of the study (approximately 12 months)
  • Completion and review of knowledge assement quiz

Exclusion Criteria:

  • Pregnant (by history or as ascertained by pregnancy test) or lactating female
  • Female who intends to become pregnant during the study
  • Plan to have elective surgery during the study period
  • HIV infection
  • Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed)
  • History of splenectomy
  • Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination
  • Evidence of active (acute or chronic) hepatitis B or C infection
  • Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease
  • Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening
  • Clinical or laboratory evidence of significant anemia
  • History of flavivirus infection or previous receipt of flavivirus vaccine
  • Positive serology for flaviviruses (all four dengue virus serotypes, Japanese encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period.
  • Previous history of allergic or anaphylactic reaction to any vaccine
  • Planned travel to areas with endemic dengue during the study period
  • Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290147

Locations
United States, Maryland
Walter Reed Army Institute of Research, Bldg 503
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Charmagne Beckett, MD Naval Medical Research Center
  More Information

No publications provided by Walter Reed Army Institute of Research (WRAIR)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00290147     History of Changes
Other Study ID Numbers: NMRC 2004.0002, WRAIR 1191, HSRRB A-13304, 62787A 810S A0235
Study First Received: February 9, 2006
Last Updated: June 26, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Dengue
DNA vaccine

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 16, 2013