Study of HBV-001 D1 in Healthy Adults

Dengue Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936429
• Other study ID #: HBV-001-C-101
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2009
• Last updated: February 3, 2011
• Start date: July 2009
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Hawaii Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Intervention

Biological:
• DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)
3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.
• Placebo for DEN1-80E
3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.

Locations

Country	Name	City	State
United States	Saint Louis University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Hawaii Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No