Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 9, 2006
June 26, 2009
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 ClinicalTrials.gov Archive Site
Measurement of anti-dengue antibody and T cell responses.
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Dengue
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. Epub 2010 Nov 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00290147
NMRC 2004.0002, WRAIR 1191, HSRRB A-13304, 62787A 810S A0235
Not Provided
Not Provided
U.S. Army Office of the Surgeon General
U.S. Army Medical Research and Materiel Command
Principal Investigator: Charmagne Beckett, MD Naval Medical Research Center
Walter Reed Army Institute of Research (WRAIR)
June 2009

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