Study of HBV-001 D1 in Healthy Adults

Phase 1

Completed

• Conditions: Dengue Fever
• Interventions: Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel); Biological: Placebo for DEN1-80E

• Registration Number: NCT00936429
• Lead Sponsor: Hawaii Biotech, Inc.

Brief 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.

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Primary Completion: 2010-07
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-03
• Last Update Posted: 2011-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 µg DEN1-80E + 3.5 mg Alhydrogel	DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)	Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8.
50 µg DEN1-80E + 3.5 mg Alhydrogel	DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)	Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8.
Placebo	Placebo for DEN1-80E	Administration of placebo vaccine at Weeks 0, 4, and 8.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Saint Louis University; 🇺🇸 St. Louis, Missouri, United States