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Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

This study has been completed.
Sponsor:
Collaborator:
United States Army Medical Materiel Development Activity
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00290147
First received: February 9, 2006
Last updated: March 2, 2017
Last verified: March 2017

February 9, 2006
March 2, 2017
January 2006
December 2006   (Final data collection date for primary outcome measure)
Safety and Reactogenicity of D1ME100 [ Time Frame: 12 months ]
Safety and reactogenicity as evaluated by serious adverse events and adverse events
Safety and reactogenicity as evaluated by clinical visits and safety labs.
Complete list of historical versions of study NCT00290147 on ClinicalTrials.gov Archive Site
Anti-dengue Antibody and T-cell and B-cell Responders [ Time Frame: 12 months ]
Measurement of anti-dengue antibody and T-cell and B-cell responses induced in volunteers by administration of D1ME100. Both T-cell and B-cell ELISPOT assays were performed for each of the 4 envelope (80%) proteins D1-D4. A positive ELISPOT assay was defined as >65 spot forming cells per million PBMC for T-cells and >20 spot forming cells per million PBMC for B-cells
Measurement of anti-dengue antibody and T cell responses.
Not Provided
Not Provided
 
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
An Open-Label, Dose Escalation, Phase I Safety, and Immunogenicity Trial of a Dengue Serotype 1 (DEN-1) Premembrane (prM) and Envelope (E) DNA Vaccine (D1ME100) in Healthy Adults Volunteers
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
Intervention Model: Single Group Assignment
Masking: No masking
Masking Description:
Open Label
Primary Purpose: Prevention
Dengue
Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
IM injection delivered by Biojector
  • Experimental: 1.0 mg of D1ME100 vaccine
    1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
    Intervention: Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
  • Experimental: 5.0 mg of D1ME100 vaccine
    5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
    Intervention: Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
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
22
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)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00290147
NMRC 2004.0002
WRAIR 1191 ( Other Identifier: WRAIR ID )
HSRRB A-13304 ( Other Identifier: IRB )
62787A 810S A0235 ( Other Identifier )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
U.S. Army Medical Research and Materiel Command
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
March 2017

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