Safety Study of HBV-002 West Nile Vaccine in Healthy Adults

Study Overview
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Brief Summary
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The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in healthy adults.

Detailed Description
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West Nile virus is an emerging infectious disease in the U.S. and worldwide and has been identified by the CDC as a significant public health risk. Since the introduction of West Nile virus into the U.S. in 1999, annual outbreaks have caused severe and fatal encephalitis in humans and equines and death in a variety of species of feral birds throughout the U.S. and parts of Canada. In addition, more recent findings show evidence of West Nile virus human and equine infection in several countries of tropical America. The virus has now been found in bird populations in all 48 states of the continental U.S, and human cases of West Nile disease have been documented in 45 states and the District of Columbia. To date, there is no approved commercial vaccine available for prevention of West Nile virus disease in humans.

Official Title
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Phase 1, Open-Label, Safety Study of HBV-002 (West Nile Recombinant Subunit Vaccine) in Healthy Adults

Conditions
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West Nile Virus Disease

Intervention / Treatment
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* Biological: WN-80E
* Biological: WN-80E
* Biological: WN-80E
* Biological: WN-80E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Satisfactory medical assessment with no clinically significant and relevant abnormalities (medical history, physical examination, vital signs, ECG, clinical laboratory evaluation [hematology, biochemistry, urinalysis]) Body weight must not be more than 10% below of 20% above the ideal weight for height and frame size according to the 1999 Metropolitan Life table Exclusion Criteria: Current active infection process including URI or influenza Positive serum test for HIV, Hepatitis B surface antigens and/or Hepatitis C antibodies History of infection with, or serologic evidence in screening test, of prior flavivirus infection (to include viruses: West Nile, 4 dengue serotypes, yellow fever (YF), and Japanese encephalitis (JE) Subject has resided in flavivirus (West Nile, 4 dengue serotypes, YF, and JE) endemic areas or has a history of receipt of Yellow Fever or Japanese encephalitis virus vaccines History of alcohol or other substance abuse within 1 year of screening Use of corticosteroids or immunosuppressive drugs within 30 days of screening (Use of topical or nasal corticosteroids are not excluded.) Any confirmed or suspected immunosuppressive or immunodeficient condition Administration of immunoglobulins within three months of the first vaccination or planned during the study period Receipt of any vaccines or investigational or non-registered product other than HBV-002 within 30 days prior to screening or planned receipt throughout the study. Receipt of another study vaccines within 30 days prior to screening Receipt of blood products within 6 months of screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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<br>Low Dose WN-80E API (5 µg) + Alhydrogel (3.5 mg) | Biological: WN-80E<br>* Three injections of the study vaccine [Low Dose of WN-80E API (5 µg) + Alhydrogel (3.5 mg)] given one month apart<br>* Other names: HBV-002 vaccine;|
| Experimental: 2<br>Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg) | Biological: WN-80E<br>* Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart<br>* Other names: HBV-002 vaccine;|
| Experimental: 3<br>High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg) | Biological: WN-80E<br>* Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart<br>* Other names: HBV-002 vaccine;|
| Experimental: 4<br>High Dose WN-80E API (50 µg), no adjuvant | Biological: WN-80E<br>* Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart<br>* Other names: HBV-002 vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and tolerability of the study HBV-002 formulations in healthy adult subjects |  | 38 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the immunogenicity of HBV-002 |  | 38 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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West Nile Virus, West Nile Vaccine, West Nile virus disease, Hawaii Biotech