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Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

Primary Purpose

Dengue

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue focused on measuring Dengue, DNA vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Walter Reed Army Institute of Research, Bldg 503

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1.0 mg of D1ME100 vaccine

5.0 mg of D1ME100 vaccine

Arm Description

1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months

5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months

Outcomes

Primary Outcome Measures

Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination

Secondary Outcome Measures

Anti-dengue Antibody and T-cell and B-cell Responders
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

Full Information

First Posted
February 9, 2006
Last Updated
May 23, 2017
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
United States Army Medical Materiel Development Activity
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1. Study Identification

Unique Protocol Identification Number
NCT00290147
Brief Title
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
Collaborators
United States Army Medical Materiel Development Activity

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
Keywords
Dengue, DNA vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.0 mg of D1ME100 vaccine
Arm Type
Experimental
Arm Description
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
Arm Title
5.0 mg of D1ME100 vaccine
Arm Type
Experimental
Arm Description
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
Intervention Type
Biological
Intervention Name(s)
D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
Intervention Description
IM injection delivered by Biojector
Primary Outcome Measure Information:
Title
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Description
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
Time Frame
Months 0, 1 and 5
Secondary Outcome Measure Information:
Title
Anti-dengue Antibody and T-cell and B-cell Responders
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charmagne Beckett, MD
Organizational Affiliation
Naval Medical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Institute of Research, Bldg 503
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29363446
Citation
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.
Results Reference
derived
PubMed Identifier
21111785
Citation
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.
Results Reference
derived

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Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

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