Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

Phase 1

Completed

Conditions: Dengue

Interventions: Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)

Registration Number: NCT00290147

Lead Sponsor: U.S. Army Medical Research and Development Command

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1.0 mg of D1ME100 vaccine	D1ME100 (dengue-1 premembrane/envelope DNA vaccine)	1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
5.0 mg of D1ME100 vaccine	D1ME100 (dengue-1 premembrane/envelope DNA vaccine)	5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months

Primary Outcome Measures

Name	Time	Method
Systemic and Local Reactogenicity Rates for Ungraded Symptoms	Months 0, 1 and 5	Summary of ungraded systemic and local reactogenicity symptoms following each vaccination

Secondary Outcome Measures

Name	Time	Method
Anti-dengue Antibody and T-cell and B-cell Responders	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