Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease
TVDV
A Phase 1 Study To Evaluate The Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue (Serotype 1, 2, 3, and 4) Plasmid DNA Vaccine (TVDV) Formulated With and Without Vaxfectin®
4 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine whether a new investigational dengue vaccine is safe, well-tolerated, and to see if an immune response against dengue disease will be generated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2011
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 4, 2016
April 1, 2015
2 years
December 15, 2011
November 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events (AEs) or serious adverse events (SAEs)
All AEs and SAEs will be recorded during the entire duration of the study, or up to 360 days.
Up to Day 360
Secondary Outcomes (3)
Percent of subjects (in each group) achieving tetravalent ELISA IgM seroconversion
Days 0-360
Percent of subjects (in each group) achieving tetravalent seroconversion, by dengue plaque reduction MN50 titer
Days 0-360
MN50 titer 1 month (Study Day 120) and Study Days 180 and 270 after vaccine regimen is complete
Following completion of study days 120 and 180 and 270 days after vaccine regimen is complete
Study Arms (3)
Tetravalent Dengue Vaccine (TVDV)
EXPERIMENTALlow dose (no adjuvant)
Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)
EXPERIMENTALlow dose (with adjuvant)
Tetravalent dengue Vaccine (TVDV) with Vaxfectin® (high-dose)
EXPERIMENTALhigh dose (with adjuvant)
Interventions
Low dose delivered intramuscularly on Study Days 0, 30 and 90
Low dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
High dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
Eligibility Criteria
You may qualify if:
- Male or female age 18 to 50 (inclusive) years old at the time of enrollment
- Have negative anti-dengue, Japanese encephalitis, West Nile, and yellow fever ELISA serological tests
- Be informed of the nature of the study and provide written informed consent
- If the subject is of child-producing potential, he/she agrees to practice adequate birth control or abstain from sex
- Have access to the WRAIR Clinical Trials for at least 270 days, and be willing to refrain from participation in other investigational clinical trials
- Be in good general health
You may not qualify if:
- History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, yellow fever, and dengue
- Have a known or suspected hypersensitivity or adverse reaction to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain
- Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0
- Have a positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV antibody
- Are pregnant or breastfeeding
- Have donated or received blood, blood products, or plasma within 30 days prior to Day 0
- Have any acute illness, including an oral body temperature \>100.4°F, within 7 days before the initial injection on Day 0
- Have a past or current history of malignant disease except for adequately treated skin cancer
- Have participated in an investigational drug, vaccine, or device study within a period of 30 days prior to Day 0;
- History of splenectomy
- Planned travel to dengue endemic areas during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- U.S. Army Medical Research and Development Commandlead
- Vicalcollaborator
- Walter Reed Army Institute of Research (WRAIR)collaborator
- Naval Medical Research Centercollaborator
Study Sites (1)
Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC)
Silver Spring, Maryland, 20702, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janine R Danko, MD
Naval Medical Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 30, 2011
Study Start
December 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
November 4, 2016
Record last verified: 2015-04