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Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease (TVDV)

Primary Purpose

Dengue Disease, Dengue Fever

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tetravalent Dengue Vaccine (TVDV)

Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)

Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)

About this trial

This is an interventional prevention trial for Dengue Disease focused on measuring dengue, dengue fever, dengue disease, tetravalent dengue vaccine, Vaxfectin®

Eligibility Criteria

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

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

Sites / Locations

Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Tetravalent Dengue Vaccine (TVDV)

Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)

Tetravalent dengue Vaccine (TVDV) with Vaxfectin® (high-dose)

Arm Description

low dose (no adjuvant)

low dose (with adjuvant)

high dose (with adjuvant)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent of subjects (in each group) achieving tetravalent ELISA IgM seroconversion

From date of first vaccine dose until seroconversion is achieved, up to 360 days.

Percent of subjects (in each group) achieving tetravalent seroconversion, by dengue plaque reduction MN50 titer

From date of first vaccine dose until seroconversion is achieved, up to 360 days.

MN50 titer 1 month (Study Day 120) and Study Days 180 and 270 after vaccine regimen is complete

Full Information

NCT ID

NCT01502358

First Posted

December 15, 2011

Last Updated

November 3, 2016

Sponsor

U.S. Army Medical Research and Development Command

Collaborators

Vical, Walter Reed Army Institute of Research (WRAIR), Naval Medical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT01502358

Brief Title

Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease

Acronym

TVDV

Official Title

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®

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

U.S. Army Medical Research and Development Command

Collaborators

Vical, Walter Reed Army Institute of Research (WRAIR), Naval Medical Research Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dengue Disease, Dengue Fever

Keywords

dengue, dengue fever, dengue disease, tetravalent dengue vaccine, Vaxfectin®

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tetravalent Dengue Vaccine (TVDV)

Arm Type

Experimental

Arm Description

low dose (no adjuvant)

Arm Title

Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)

Arm Type

Experimental

Arm Description

low dose (with adjuvant)

Arm Title

Tetravalent dengue Vaccine (TVDV) with Vaxfectin® (high-dose)

Arm Type

Experimental

Arm Description

high dose (with adjuvant)

Intervention Type

Biological

Intervention Name(s)

Tetravalent Dengue Vaccine (TVDV)

Intervention Description

Low dose delivered intramuscularly on Study Days 0, 30 and 90

Intervention Type

Biological

Intervention Name(s)

Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)

Intervention Description

Low dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90

Intervention Type

Biological

Intervention Name(s)

Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)

Intervention Description

High dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90

Primary Outcome Measure Information:

Title

Number of participants with adverse events (AEs) or serious adverse events (SAEs)

Description

All AEs and SAEs will be recorded during the entire duration of the study, or up to 360 days.

Time Frame

Up to Day 360

Secondary Outcome Measure Information:

Title

Percent of subjects (in each group) achieving tetravalent ELISA IgM seroconversion

Description

From date of first vaccine dose until seroconversion is achieved, up to 360 days.

Time Frame

Days 0-360

Title

Percent of subjects (in each group) achieving tetravalent seroconversion, by dengue plaque reduction MN50 titer

Description

From date of first vaccine dose until seroconversion is achieved, up to 360 days.

Time Frame

Days 0-360

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janine R Danko, MD

Organizational Affiliation

Naval Medical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC)

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20702

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease

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