Contact information
Type
Scientific
Primary contact
Prof Hans Ludger Tillmann
ORCID ID
Contact details
University Leipzig
Medical clinic II
Philipp-Rosenthal-Str. 27
Leipzig
04103
Germany
+49 (0)341 971 2226
Hans.Tillmann@medizin.uni-leipzig.de
Additional identifiers
EudraCT number
2007-001744-53
ClinicalTrials.gov number
Protocol/serial number
EudraCT-Nr.: 2007-001744-53
Study information
Scientific title
Acronym
PAI-Study
Study hypothesis
Is there a better response to active hepatitis B immunisation with the parallel administration of passive antibodies?
Ethics approval
Ethics approval received from the Ethics Committee of University Leipzig on the 25th April 2008.
Study design
Prospective, two-armed, open, randomised, mono-centre, phase IIb trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hepatitis B immunisation
Intervention
One arm receives active intramuscular (i.m.) vaccination with 10 µg HBVAXPROTM on weeks 0, 2, 4, 16 and 18. One arm receives active i.m. vaccination with 10 µg HBVAXPROTM on weeks 0, 2, 4, 16 and 18, plus Hepatect® prior to the week 0, 4, and 16 active vaccination. Duration of follow-up is 6 months for both arms.
Intervention type
Drug
Phase
Phase II/III
Drug names
Hepatitis B vaccination (HBVAXPRO), hepatitis B immunoglobulins (Hepatect)
Primary outcome measures
The result of the vaccination strategy, defined as the achievement of the protective anti-HBs antibody titre (PAT) greater than 100 IU/ml during the treatment period (that is including week 22).
Secondary outcome measures
1. Time from start of treatment to achievement of the protective anti-HBs antibody titre (PST)
2. Amount of anti-HBs antibody titre (UI/ml) on week 22
3. Adverse and serious adverse events
4. Anti-HBs antibody titre during treatment (week 0 - 22) and during the 6 month follow-up
Overall trial start date
01/08/2008
Overall trial end date
01/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. No adequate response to a previous triple sole active hepatitis B vaccination (anti-HBs titre less than 100 IU/ml)
2. Written informed consent for participation in the study
3. Aged 18 to 65 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Hepatitis B surface antigen (HBsAg) positive
2. Anti-hepatitis C virus (Anti-HCV) positive
3. Anti-human immunodeficiency virus (Anti-HIV) positive
4. Any serious or active physical or psychological disease which has an impact on the treatment option or the compliance of the subject by estimation of investigator
5. Known or obvious pre-existing liver disease (e.g., M. Wilson, haemochromatosis, autoimmune hepatitis, hepatitis C). These diseases are clinically relevant renal, cardiac, pulmonary, vascular or metabolic (disease of thyroid, adrenal disease) diseases, an immune compromised status or malignant diseases
6. Intake of hepatotoxic agents (e.g. aminoglycoside, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidin, tacrolimus, cyclosporin), or a foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion
7. Intake of nephrotoxic agents (e.g. anabolic steroids, ketokonazol, itrakonazol, isoniazid, rifampicin, rifabutin, statine), or a foreseeable necessity or intention for taking of these therapeutics within the last two months prior to screening or at inclusion
8. Treatment with immunoglobulins, interferon or other immunologic or cytokines-based therapy concepts with possible impact on a hepatitis B infection, or a foreseeable necessity or intention for taking these therapeutics within the last six months prior to screening or at inclusion
9. Treatment with steroids, immunosuppressives or chemotherapeutic agents, or a foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion
10. Subjects with known thrombophilic disease and/or previous thromboembolic events in the anamnesis
11. Organ or bone marrow engrafted subjects
12. Concomitant participation in other clinical trials or treatment with another investigational drug within the last 2 months prior to screening
13. Planned vaccination outside the vaccination for the trial during the whole study time (e.g. vaccination of influenza)
14. Ongoing alcohol or drug abuse which has an impact on the compliance of the subject, the result of the vaccination during the whole study time or the evaluation of adverse events
15. Allergic reaction to vaccinations or immunoglobulins in anamnesis
16. Women during pregnancy and lactation
17. Women with child bearing potential (less than 2 years after the last menstruation) without effective contraception (implants, injections, oral contraception, intrauterine devices - spirals etc., partner with vasectomy) during the trial (subjects who takes a hormonal method of contraception will be informed about possible effects of the study medication)
Recruitment start date
01/08/2008
Recruitment end date
01/02/2010
Locations
Countries of recruitment
Germany
Trial participating centre
University Leipzig
Leipzig
04103
Germany
Sponsor information
Organisation
University of Leipzig (Germany)
Sponsor details
c/o Prof. Hans Ludger Tillmann
Medical clinic II
Philipp Rosenthal Str. 27
Leipzig
04103
Germany
+49 (0)341 9712226
Hans.Tillmann@medizin.uni-leipzig.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Biotest AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanofi Pasteur MSD GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary