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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: May 23, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.

Condition Intervention Phase
Dengue Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Masking Description:
Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Systemic and Local Reactogenicity Rates for Ungraded Symptoms [ Time Frame: Months 0, 1 and 5 ]
    Summary of ungraded systemic and local reactogenicity symptoms following each vaccination


Secondary Outcome Measures:
  • Anti-dengue Antibody and T-cell and B-cell Responders [ Time Frame: 12 months ]
    Number of participants who responded, are reported. Response or 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


Enrollment: 22
Study Start Date: January 2006
Study Completion Date: April 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
IM injection delivered by Biojector
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
Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
IM injection delivered by Biojector

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical Research and Materiel Command
United States Army Medical Materiel Development Activity
Investigators
Principal Investigator: Charmagne Beckett, MD Naval Medical Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00290147     History of Changes
Other Study ID Numbers: NMRC 2004.0002
WRAIR 1191 ( Other Identifier: WRAIR ID )
HSRRB A-13304 ( Other Identifier: IRB )
62787A 810S A0235 ( Other Identifier )
Study First Received: February 9, 2006
Results First Received: March 2, 2017
Last Updated: May 23, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by U.S. Army Medical Research and Materiel Command:
Dengue
DNA vaccine

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017