Study of HBV-001 D1 in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
Hawaii Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT00936429
First received: July 8, 2009
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Dengue Fever
Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
Biological: Placebo for DEN1-80E
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Hawaii Biotech, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 µg DEN1-80E + 3.5 mg Alhydrogel
Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8.
Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.
Other Name: HBV-001 D1
Experimental: 50 µg DEN1-80E + 3.5 mg Alhydrogel
Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8.
Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.
Other Name: HBV-001 D1
Placebo Comparator: Placebo
Administration of placebo vaccine at Weeks 0, 4, and 8.
Biological: Placebo for DEN1-80E
3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936429

Locations
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63104
Sponsors and Collaborators
Hawaii Biotech, Inc.
Investigators
Study Director: Beth-Ann Coller, PhD Hawaii Biotech, Inc.
  More Information

No publications provided

Responsible Party: Michele Yelmene, Hawaii Biotech, Inc
ClinicalTrials.gov Identifier: NCT00936429     History of Changes
Other Study ID Numbers: HBV-001-C-101
Study First Received: July 8, 2009
Last Updated: February 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Hawaii Biotech, Inc.:
Dengue fever
Dengue hemorrhagic fever
Dengue shock syndrome
Vaccine
Hawaii Biotech

Additional relevant MeSH terms:
Dengue
Dengue Hemorrhagic Fever
Fever
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014