Safety Study of a Dengue Virus DNA Vaccine - Full Text View

Sponsors and Collaborators:	U.S. Army Office of the Surgeon General U.S. Army Medical Research and Materiel Command
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00290147

Purpose

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

Condition	Intervention	Phase
Dengue	Biological: D1ME (dengue-1 premembrane/envelope DNA vaccine)	Phase I

MedlinePlus related topics: Dengue

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I Clinical Trial of a Dengue-1 DNA Vaccine

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:

Safety and reactogenicity as evaluated by clinical visits and safety labs.

Secondary Outcome Measures:

Measurement of anti-dengue antibody and T cell responses.

Estimated Enrollment:	24
Study Start Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290147

Locations

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

Sponsors and Collaborators

U.S. Army Office of the Surgeon General

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:

Jeff A Tjaden, MD, MPH

Naval Medical Research Center

More Information

Study ID Numbers:	NMRC 2004.0002, WRAIR 1191, HSRRB A-13304, 62787A 810S A0235
Study First Received:	February 9, 2006
Last Updated:	April 11, 2007
ClinicalTrials.gov Identifier:	NCT00290147
Health Authority:	United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):

Dengue
DNA vaccine

Study placed in the following topic categories:

Fever
Virus Diseases
Hemorrhagic Fevers, Viral
Dengue
Hemorrhagic fever

Viral hemorrhagic fever
Dengue fever
Arbovirus Infections
Dengue Hemorrhagic Fever

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009