Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

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

Detailed Description
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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.

Official Title
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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

Conditions
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Dengue

Intervention / Treatment
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* Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0 mg of D1ME100 vaccine<br>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)<br>* IM injection delivered by Biojector<br>|
| Experimental: 5.0 mg of D1ME100 vaccine<br>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)<br>* IM injection delivered by Biojector<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic and Local Reactogenicity Rates for Ungraded Symptoms | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dengue, DNA vaccine