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

NCT ID: NCT00354861

Last Updated: 2008-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-02-28

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.

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.

Conditions

Healthy

Keywords

Healthy volunteers; IMP321; Adjuvant; Pharmacodynamics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

A

IMP321

Group Type: EXPERIMENTAL

hepatitis B antigen (without alum) plus IMP321

Intervention Type: BIOLOGICAL

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

B

Saline

Group Type: PLACEBO_COMPARATOR

hepatitis B antigen alone (without alum)

Intervention Type: BIOLOGICAL

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

C

Engerix B

Group Type: ACTIVE_COMPARATOR

Engerix B

Intervention Type: BIOLOGICAL

20 µg hepatitis B antigen absorbed on alum

Interventions

hepatitis B antigen (without alum) plus IMP321

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

Intervention Type: BIOLOGICAL

hepatitis B antigen alone (without alum)

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

Intervention Type: BIOLOGICAL

Engerix B

20 µg hepatitis B antigen absorbed on alum

Intervention Type: BIOLOGICAL

Other Intervention Names

CD223; hLAG-3Ig; LAG-3

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SGS Aster-Cephac (CRO)

UNKNOWN

Sponsor Role: collaborator

Immutep S.A.S.

INDUSTRY

Sponsor Role: lead

Responsible Party

Immutep S.A.

Principal Investigators

Didier Chassard, M.D.

Role: PRINCIPAL_INVESTIGATOR

SGS Aster-Cephac

Locations

SGS Aster-Cephac

Paris, , France

Countries

France

Related Links

http://www.immutep.com

Sponsor's website

Other Identifiers

Aster-P020256

Identifier Type: -

Identifier Source: secondary_id

P002

Identifier Type: -

Identifier Source: org_study_id