Study of HBV-001 D1 in Healthy Adults

Study Overview
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Brief Summary
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This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.

Detailed Description
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This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts. Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.

Official Title
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Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults

Conditions
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Dengue Fever

Intervention / Treatment
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* Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
* Biological: Placebo for DEN1-80E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 18 to 45. Body weight ≥ 110 pounds (50 kg). Satisfactory medical condition established by medical history and physical examination. Females must be of non-child bearing potential (i.e., surgically sterile) or, if of child-bearing potential must be abstinent or willing to employ adequate means of contraception. Exclusion Criteria: Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies. Abuse of drugs or alcohol within 12 months prior to screening. Use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids is allowed). Any confirmed or suspected immunosuppressive or immunodeficient condition. Receipt of any vaccination within 30 days prior to screening. Receipt of blood products within 6 months of screening. Previous flavivirus vaccination (e.g., Japanese encephalitis or yellow fever) or flavivirus vaccination planned during the study period. History of flavivirus infection. No easy access to a fixed or mobile telephone. History of residing in a country endemic for dengue, Japanese encephalitis virus, or Yellow Fever virus for a period of > 1 year. Donation of ≥ 450 mL of blood within the previous 12 weeks.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 µg DEN1-80E + 3.5 mg Alhydrogel<br>Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8. | Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)<br>* 3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.<br>* Other names: HBV-001 D1;|
| Experimental: 50 µg DEN1-80E + 3.5 mg Alhydrogel<br>Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8. | Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)<br>* 3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.<br>* Other names: HBV-001 D1;|
| Placebo Comparator: Placebo<br>Administration of placebo vaccine at Weeks 0, 4, and 8. | Biological: Placebo for DEN1-80E<br>* 3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data |  | Assessed at each study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses |  | Every 2 weeks during treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dengue fever, Dengue hemorrhagic fever, Dengue shock syndrome, Vaccine, Hawaii Biotech