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Safety Study of a Dengue Virus DNA Vaccine

This study has been completed.
United States Army Medical Materiel Development Activity
Information provided by:
U.S. Army Medical Research and Materiel Command Identifier:
First received: February 9, 2006
Last updated: October 24, 2016
Last verified: June 2009

February 9, 2006
October 24, 2016
January 2006
December 2006   (Final data collection date for primary outcome measure)
Safety and reactogenicity as evaluated by clinical visits and safety labs.
Same as current
Complete list of historical versions of study NCT00290147 on Archive Site
Measurement of anti-dengue antibody and T cell responses.
Same as current
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Safety Study of a Dengue Virus DNA Vaccine
Phase I Clinical Trial of a Dengue-1 DNA Vaccine
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
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.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Biological: D1ME (dengue-1 premembrane/envelope DNA vaccine)
Not Provided
Beckett CG, Tjaden J, Burgess T, Danko JR, Tamminga C, Simmons M, Wu SJ, Sun P, Kochel T, Raviprakash K, Hayes CG, Porter KR. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. Vaccine. 2011 Jan 29;29(5):960-8. doi: 10.1016/j.vaccine.2010.11.050.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2009
December 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NMRC 2004.0002
WRAIR 1191
HSRRB A-13304
62787A 810S A0235
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U.S. Army Medical Research and Materiel Command
United States Army Medical Materiel Development Activity
Principal Investigator: Charmagne Beckett, MD Naval Medical Research Center
U.S. Army Medical Research and Materiel Command
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP