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
4 other identifiers
interventional
22
1 country
1
Brief Summary
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2006
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
April 14, 2017
CompletedJune 20, 2017
May 1, 2017
11 months
February 9, 2006
March 2, 2017
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
Months 0, 1 and 5
Secondary Outcomes (1)
Anti-dengue Antibody and T-cell and B-cell Responders
12 months
Study Arms (2)
1.0 mg of D1ME100 vaccine
EXPERIMENTAL1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
5.0 mg of D1ME100 vaccine
EXPERIMENTAL5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
Interventions
IM injection delivered by Biojector
Eligibility Criteria
You may qualify if:
- Available to participate for the duration of the study (approximately 12 months)
- Completion and review of knowledge assement quiz
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walter Reed Army Institute of Research, Bldg 503
Silver Spring, Maryland, 20910, United States
Related Publications (2)
Danko JR, Kochel T, Teneza-Mora N, Luke TC, Raviprakash K, Sun P, Simmons M, Moon JE, De La Barrera R, Martinez LJ, Thomas SJ, Kenney RT, Smith L, Porter KR. Safety and Immunogenicity of a Tetravalent Dengue DNA Vaccine Administered with a Cationic Lipid-Based Adjuvant in a Phase 1 Clinical Trial. Am J Trop Med Hyg. 2018 Mar;98(3):849-856. doi: 10.4269/ajtmh.17-0416. Epub 2018 Jan 18.
PMID: 29363446DERIVEDBeckett 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.
PMID: 21111785DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charmagne Beckett, LCDR, MC, USNR
- Organization
- Naval Medical Research Center, Viral Diseases Department
Study Officials
- PRINCIPAL INVESTIGATOR
Charmagne Beckett, MD
Naval Medical Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 10, 2006
Study Start
January 1, 2006
Primary Completion
December 1, 2006
Study Completion
April 1, 2009
Last Updated
June 20, 2017
Results First Posted
April 14, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share