Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354861
Status:
COMPLETED
Last Update Posted:
2008-04-25
First Post:
2006-07-19
Brief Title:
A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321
Sponsor:
Immutep SAS
Organization:
Immutep SAS
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Aster-P020256 | None | None | None |