NCT00354861

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Immutep S.A.S. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-05-01
• Primary completion: 2005-11-01
• Completion: 2006-02-01
• First posted: 2006-07-20
• Last updated: 2008-04-25

Locations

1 site across 1 country: France