Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT00354861
Status:
COMPLETED
Last Update Posted:
2008-04-25
First Post:
2006-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321
Sponsor:
Immutep S.A.S.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Aster-P020256 | None | None | View |