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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354861
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : April 25, 2008
Sponsor:
Collaborator:
SGS Aster-Cephac (CRO)
Information provided by:
Immutep S.A.

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: hepatitis B antigen (without alum) plus IMP321 Biological: hepatitis B antigen alone (without alum) Biological: Engerix B Phase 1

Detailed Description:

In each cohort, 8 subjects will receive the hepatitis B antigen (10 µg) with IMP321 at one dose, 2 subjects will receive the reference hepatitis B antigen (10 µg) alone with physiological saline and 2 subjects will receive the commercial vaccine Engerix B® (20 µg).

Engerix B® will be administered intramuscularly. The other treatments will be administered subcutaneously.

The four successive cohorts of volunteers will be:

Cohort A:

  • 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (3 µg),
  • 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline,
  • 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).

If the tolerability of this cohort is acceptable, the following cohort will be done.

Cohort B:

  • 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (10 µg),
  • 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with Physiological saline,
  • 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).

If the tolerability of this cohort is acceptable, the following cohort will be done.

Cohort C:

  • 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (30 µg),
  • 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline,
  • 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).

If the tolerability of this cohort is acceptable, the following cohort will be done.

Cohort D:

  • 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (100 µg),
  • 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline
  • 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).

Blood samples will be collected on the morning of days 1, 29, 36, 57 and 85 for pharmacodynamic evaluation.

Monitoring for the occurrence of adverse events (AE), changes in physical examination, vital signs (blood pressure, pulse rate, respiration), electrocardiograms (ECG) and clinical laboratory tests (biochemistry, haematology, urinalysis) will be performed before and after each dose of the study drug to assess safety and tolerability.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Phase I, Single-Blind Study to Determine the Safety, Tolerability and Pharmacodynamic Profiles of a Hepatitis B Antigen Combined With IMP321 Versus the Hepatitis B Antigen Alone and a Reference Vaccine in Healthy Young Male Volunteers
Study Start Date : May 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
IMP321
Biological: hepatitis B antigen (without alum) plus IMP321
hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321
Other Names:
  • CD223
  • hLAG-3Ig
  • LAG-3

Placebo Comparator: B
Saline
Biological: hepatitis B antigen alone (without alum)
hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline

Active Comparator: C
Engerix B
Biological: Engerix B
20 µg hepatitis B antigen absorbed on alum




Primary Outcome Measures :
  1. To evaluate clinical and laboratory safety and tolerability profiles [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. To determine T cell response induction efficacy [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 have received any experimental drug within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health ;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354861


Locations
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France
SGS Aster-Cephac
Paris, France, 75015
Sponsors and Collaborators
Immutep S.A.
SGS Aster-Cephac (CRO)
Investigators
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Principal Investigator: Didier Chassard, M.D. SGS Aster-Cephac
Additional Information:
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Responsible Party: F. Triebel, Chief Medical Officer, Immutep S.A.
ClinicalTrials.gov Identifier: NCT00354861    
Other Study ID Numbers: P002
Aster-P020256
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: April 25, 2008
Last Verified: April 2008
Keywords provided by Immutep S.A.:
Healthy volunteers
IMP321
Adjuvant
Pharmacodynamics
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Aluminum sulfate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs