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A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321

NCT00354861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2008-04-25

No results posted yet for this study

Summary

This is a single centre, three single administrations (Days 1, 29 and 57) at increasing doses of IMP321 (3, 10, 30 and 100 µg) in four cohorts of 12 subjects, single blind, randomized study.

Conditions

  • Healthy

Interventions

BIOLOGICAL

hepatitis B antigen (without alum) plus IMP321

hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321

BIOLOGICAL

hepatitis B antigen alone (without alum)

hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline

BIOLOGICAL

Engerix B

20 µg hepatitis B antigen absorbed on alum

Sponsors & Collaborators

  • SGS Aster-Cephac (CRO)

    collaborator UNKNOWN

  • Immutep S.A.S.

    lead INDUSTRY

Principal Investigators

  • Didier Chassard, M.D. · SGS Aster-Cephac

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2005-11-30
Completion
2006-02-28

Countries

  • France

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 NCT00354861 on ClinicalTrials.gov