- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01502358
Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease (TVDV)
November 3, 2016 updated by: U.S. Army Medical Research and Development Command
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®
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Arguably the need for a tetravalent dengue vaccine that will effectively induce immunity against all four dengue serotypes has never been greater.
Currently, several different approaches are being taken to develop a protective tetravalent dengue vaccine.
These include live-attenuated vaccines derived by serial passage in tissue culture, live chimeric vaccines, recombinant protein vaccines and DNA vaccines.
While live attenuated and live chimeric vaccines have shown promise in clinical trials, viral competition with suspected immune interference resulting in imbalanced immune responses and reactogenicity with the occurrence of dengue like symptoms remains a concern.
It is imperative that any candidate vaccine produce solid immunity against each of the four dengue virus serotypes.
Failure to do so may place the recipient of the vaccine at risk for developing severe dengue disease (dengue hemorrhagic fever/dengue shock syndrome) following exposure to the virus serotype to which there was incomplete protective immunity, resulting in antibody dependent enhancement due to the presence of non-neutralizing anti-dengue antibodies.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Silver Spring, Maryland, United States, 20702
- Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria-Subjects meeting any of the following criteria will be excluded from the study:
- 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
- Exclusions include but are not limited to conditions pertaining to or evidence of immunodeficiency; allergies requiring treatment with antigen injections; autoimmune disease; severe migraine headaches; unstable asthma; clinically significant cardiac arrhythmias, diabetes mellitus, thyroid disease, a bleeding disorder or a seizure disorder.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tetravalent Dengue Vaccine (TVDV)
low dose (no adjuvant)
|
Low dose delivered intramuscularly on Study Days 0, 30 and 90
|
EXPERIMENTAL: Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)
low dose (with adjuvant)
|
Low dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
|
EXPERIMENTAL: Tetravalent dengue Vaccine (TVDV) with Vaxfectin® (high-dose)
high dose (with adjuvant)
|
High dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events (AEs) or serious adverse events (SAEs)
Time Frame: Up to Day 360
|
All AEs and SAEs will be recorded during the entire duration of the study, or up to 360 days.
|
Up to Day 360
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of subjects (in each group) achieving tetravalent ELISA IgM seroconversion
Time Frame: Days 0-360
|
From date of first vaccine dose until seroconversion is achieved, up to 360 days.
|
Days 0-360
|
Percent of subjects (in each group) achieving tetravalent seroconversion, by dengue plaque reduction MN50 titer
Time Frame: Days 0-360
|
From date of first vaccine dose until seroconversion is achieved, up to 360 days.
|
Days 0-360
|
MN50 titer 1 month (Study Day 120) and Study Days 180 and 270 after vaccine regimen is complete
Time Frame: Following completion of study days 120 and 180 and 270 days after vaccine regimen is complete
|
Following completion of study days 120 and 180 and 270 days after vaccine regimen is complete
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Janine R Danko, MD, Naval Medical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
December 15, 2011
First Submitted That Met QC Criteria
December 28, 2011
First Posted (ESTIMATE)
December 30, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 4, 2016
Last Update Submitted That Met QC Criteria
November 3, 2016
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-11-0007
- WRAIR #1839 (OTHER: WRAIR)
- NMRC 2011.0012 (OTHER: NMRC)
- A-16892 (OTHER: IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dengue Fever
-
Sanofi Pasteur, a Sanofi CompanyCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue Virus | Dengue DiseaseVietnam
-
Sanofi Pasteur, a Sanofi CompanyCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue Virus | Dengue DiseasesPeru
-
Sanofi Pasteur, a Sanofi CompanyCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue Virus | Dengue DiseasesSingapore
-
Sanofi Pasteur, a Sanofi CompanyCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue Virus | Dengue DiseasesMexico
-
Sanofi Pasteur, a Sanofi CompanyCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue Virus | Dengue DiseasesThailand
-
Sanofi Pasteur, a Sanofi CompanyCompletedDengue Fever | Dengue Hemorrhagic FeverSingapore
-
Sanofi Pasteur, a Sanofi CompanyUnited States Department of DefenseCompletedDengue | Dengue Fever | Dengue Hemorrhagic FeverUnited States
-
U.S. Army Medical Research and Development CommandGlaxoSmithKlineCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue Shock SyndromePuerto Rico
-
SanofiCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue VirusUnited States
-
SanofiCompletedDengue | Dengue Fever | Dengue Hemorrhagic Fever | Dengue VirusAustralia
Clinical Trials on Tetravalent Dengue Vaccine (TVDV)
-
SanofiCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue VirusUnited States
-
Sanofi Pasteur, a Sanofi CompanyRecruiting
-
TakedaCompletedDengue FeverUnited States
-
Butantan InstituteFundação de Amparo à Pesquisa do Estado de São Paulo; Banco Nacional de Desenvolvimento... and other collaboratorsUnknown
-
TakedaActive, not recruitingHealthy VolunteersThailand, Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka
-
TakedaCompleted
-
TakedaCompleted
-
GlaxoSmithKlineCompleted
-
TakedaCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompletedDengue Fever | Dengue Hemorrhagic Fever | Dengue Virus | Dengue DiseasesMexico