NCT00936429

Study of HBV-001 D1 in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hawaii Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dengue Fever

Interventions

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

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-07-01
• Completion: 2011-01-01
• First posted: 2009-07-10
• Last updated: 2011-02-07

Locations

1 site across 1 country: United States