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Study of HBV-001 D1 in Healthy Adults

NCT00936429 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-02-07

No results posted yet for this study

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.

Conditions

  • Dengue Fever

Interventions

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.

Sponsors & Collaborators

  • Hawaii Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Beth-Ann Coller, PhD · Hawaii Biotech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-07-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936429 on ClinicalTrials.gov