HealthyPhase 1NCT00354861
A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321
A Phase 1 study testing hepatitis B antigen (without alum) plus IMP321, hepatitis B antigen alone (without alum) and Engerix B in people with Healthy, run by Immutep S.A.S. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- hepatitis B antigen (without alum) plus IMP321, hepatitis B antigen alone (without alum) and Engerix B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- May 2005to Feb 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 ;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- hepatitis B antigen (without alum) plus IMP321, hepatitis B antigen alone (without alum), Engerix B
- Keywords
- Healthy volunteers, IMP321, Adjuvant, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis B antigen (without alum) plus IMP321Biological
Also called CD223, hLAG-3Ig, LAG-3
hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321
hepatitis B antigen alone (without alum)Biological
hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline
Engerix BBiological
20 µg hepatitis B antigen absorbed on alum
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | IMP321 Receives: Biological: hepatitis B antigen (without alum) plus IMP321 |
| B | Placebo comparator | Saline Receives: Biological: hepatitis B antigen alone (without alum) |
| C | Active comparator | Engerix B Receives: Biological: Engerix B |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate clinical and laboratory safety and tolerability profiles
Measured: 3 months
Secondary outcomes (1)
To determine T cell response induction efficacy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startMay 2005
- Primary completionNov 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immutep S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Aster-Cephac (CRO)
- Investigators
- Didier Chassard, M.D., Principal investigator, SGS Aster-Cephac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354861
- Sponsor's protocol ID
- P002
- Other IDs
- Aster-P020256
- Status last verified
- Apr 2008
- First submitted
- 19 Jul 2006
- Last updated
- 25 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00354861
- Acronym / sponsor ID
- P002
- Conditions
- Healthy
- Keywords
- Healthy volunteers, IMP321, Adjuvant, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Immutep S.A.S.Industry (pharma, biotech, devices)
- Collaborators
- SGS Aster-Cephac (CRO)
- Study start
- May 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: hepatitis B antigen (without alum) plus IMP321IMP321 |
| B | Placebo comparator | Biological: hepatitis B antigen alone (without alum)Saline |
| C | Active comparator | Biological: Engerix BEngerix B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatitis B antigen (without alum) plus IMP321Also: CD223, hLAG-3Ig, LAG-3hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 | Biological | A |
| hepatitis B antigen alone (without alum)hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline | Biological | B |
| Engerix B20 µg hepatitis B antigen absorbed on alum | Biological | C |
Primary outcome
To evaluate clinical and laboratory safety and tolerability profiles
Time frame: 3 months
1 secondary outcome
To determine T cell response induction efficacy
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2008.
- Sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Chassard, M.D. principal investigator
SGS Aster-Cephac
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hepatitis B antigen (without alum) plus IMP321, hepatitis B antigen alone (without alum) and Engerix B in people with Healthy, run by Immutep S.A.S. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate clinical and laboratory safety and tolerability profiles (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2008.