NCT00354861

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2005

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
Last Updated

April 25, 2008

Status Verified

April 1, 2008

Enrollment Period

6 months

First QC Date

July 19, 2006

Last Update Submit

April 22, 2008

Conditions

Healthy

Keywords

Healthy volunteersIMP321AdjuvantPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • To evaluate clinical and laboratory safety and tolerability profiles

    3 months

Secondary Outcomes (1)

  • To determine T cell response induction efficacy

    3 months

Study Arms (3)

A

EXPERIMENTAL

IMP321

Biological: hepatitis B antigen (without alum) plus IMP321

B

PLACEBO COMPARATOR

Saline

Biological: hepatitis B antigen alone (without alum)

C

ACTIVE COMPARATOR

Engerix B

Biological: Engerix B

Interventions

hepatitis B antigen (without alum) plus IMP321BIOLOGICAL

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

Also known as: CD223, hLAG-3Ig, LAG-3
A
hepatitis B antigen alone (without alum)BIOLOGICAL

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

B
Engerix BBIOLOGICAL

20 µg hepatitis B antigen absorbed on alum

C

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • able to give a written informed consent ;
  • healthy male volunteers aged between 18 and 40 years and post-menopausal healthy women aged between 18 and 55 years;
  • with body mass index (weight/height²) in the range 18 to 30 kg/m²;
  • registered with the French Social Security in agreement with the French Law (Huriet Law : N° 88.1138 - 20.12.88) on biomedical experimentation;
  • able to comply with protocol requirements, including overnight stays, blood and urine sample collections as defined in the protocol;
  • not previously vaccinated for Hepatitis B.

You may not qualify if:

  • who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV and HCV infection ;
  • with any clinically significant abnormality following review of pre-study laboratory tests and full physical examination ;
  • who forfeit their freedom by administrative or legal award or who were under guardianship ;
  • unwilling to give their informed consent ;
  • who present a positive laboratory test for Hepatitis B surface antigen (HbsAg), HBc antibodies, HIV 1 and 2 antibodies and HCV antibodies ;
  • who have a history of allergy or intolerance to the study drug ;
  • who had a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug ;
  • who are known or suspected alcohol or drug abusers ;
  • who present a positive laboratory test for urine drug screening (opiates, barbiturates, amphetamine, cannabis) ;
  • who undergo surgery or have donated blood within 1 month prior to the start of the study ;
  • who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 1 week prior to the first dose administration ;
  • who receive any drug known to affect hepatic metabolism like cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin within 1 month prior to the first dose administration ;
  • who receive any drug known to affect renal tubular secretion like probenecid, beta-lactam antibiotics within 2 weeks prior to the first dose administration ;
  • who present any clinical condition or prior therapy which, in the opinion of the investigator, made the subject unsuitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Aster-Cephac

Paris, 75015, France

Location

Related Links

MeSH Terms

Interventions

Hepatitis B AntigensEngerix-B

Intervention Hierarchy (Ancestors)

Hepatitis AntigensAntigens, ViralViral ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Didier Chassard, M.D.

    SGS Aster-Cephac

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

May 1, 2005

Primary Completion

November 1, 2005

Study Completion

February 1, 2006

Last Updated

April 25, 2008

Record last verified: 2008-04

Locations

FR(1)