Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

May 23, 2017 updated by: U.S. Army Medical Research and Development Command

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

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

  • United States
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Walter Reed Army Institute of Research, Bldg 503

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:

  • 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

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: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1.0 mg of D1ME100 vaccine
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
IM injection delivered by Biojector
EXPERIMENTAL: 5.0 mg of D1ME100 vaccine
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
IM injection delivered by Biojector

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Time Frame: Months 0, 1 and 5
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
Months 0, 1 and 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-dengue Antibody and T-cell and B-cell Responders
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Collaborators

United States Army Medical Materiel Development Activity

Investigators

  • Principal Investigator: Charmagne Beckett, MD, Naval Medical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2006

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (ESTIMATE)

February 10, 2006

Study Record Updates

Last Update Posted (ACTUAL)

June 20, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRC 2004.0002
  • WRAIR 1191 (OTHER: WRAIR ID)
  • HSRRB A-13304 (OTHER: IRB)
  • 62787A 810S A0235 (OTHER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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