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

NCT ID: NCT01502358

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Dengue Disease Dengue Fever

Keywords

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dengue dengue fever dengue disease tetravalent dengue vaccine Vaxfectin®

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tetravalent Dengue Vaccine (TVDV)

low dose (no adjuvant)

Group Type EXPERIMENTAL

Tetravalent Dengue Vaccine (TVDV)

Intervention Type BIOLOGICAL

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

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

low dose (with adjuvant)

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

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

high dose (with adjuvant)

Group Type EXPERIMENTAL

Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)

Intervention Type BIOLOGICAL

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

Interventions

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Tetravalent Dengue Vaccine (TVDV)

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

Intervention Type BIOLOGICAL

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

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

Intervention Type BIOLOGICAL

Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vical

INDUSTRY

Sponsor Role collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role collaborator

Naval Medical Research Center

FED

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janine R Danko, MD

Role: PRINCIPAL_INVESTIGATOR

Naval Medical Research Center

Locations

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

Silver Spring, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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WRAIR #1839

Identifier Type: OTHER

Identifier Source: secondary_id

NMRC 2011.0012

Identifier Type: OTHER

Identifier Source: secondary_id

A-16892

Identifier Type: OTHER

Identifier Source: secondary_id

S-11-0007

Identifier Type: -

Identifier Source: org_study_id