Study of HBV-001 D1 in Healthy Adults

Hawaii Biotech, Inc.16 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Dengue Fever

Interventions

DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)BIOLOGICAL

3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.

Placebo for DEN1-80EBIOLOGICAL

3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Saint Louis University

St Louis, Missouri, United States

Outcomes

Primary Outcomes

To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data

Time frame: Assessed at each study visit

Secondary Outcomes

To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses

Time frame: Every 2 weeks during treatment

Data from ClinicalTrials.gov

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