Open randomised study for evaluation of an active hepatitis B vaccination (HBVAXPRO) in combination with a passive immunisation with hepatitis B immunoglobulins (Hepatect) for subjects who did not show any or an adequate reaction to a previous sole active hepatitis B immunisation

ISRCTN	ISRCTN84821453
DOI	https://doi.org/10.1186/ISRCTN84821453
EudraCT/CTIS number	2007-001744-53
Secondary identifying numbers	EudraCT-Nr.: 2007-001744-53

Submission date: 19/08/2008
Registration date: 09/10/2008
Last edited: 21/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hans Ludger Tillmann
Scientific

University Leipzig
Medical clinic II
Philipp-Rosenthal-Str. 27
Leipzig
04103
Germany

Phone	+49 (0)341 971 2226
Email	Hans.Tillmann@medizin.uni-leipzig.de

Study information

Study design	Prospective, two-armed, open, randomised, mono-centre, phase IIb trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Open randomised study for evaluation of an active hepatitis B vaccination (HBVAXPRO) in combination with a passive immunisation with hepatitis B immunoglobulins (Hepatect) for subjects who did not show any or an adequate reaction to a previous sole active hepatitis B immunisation
Study acronym	PAI-Study
Study objectives	Is there a better response to active hepatitis B immunisation with the parallel administration of passive antibodies?
Ethics approval(s)	Ethics approval received from the Ethics Committee of University Leipzig on the 25th April 2008.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	Hepatitis B vaccination (HBVAXPRO), hepatitis B immunoglobulins (Hepatect)
Primary outcome measure	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 study start date	01/08/2008
Completion date	01/02/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Total final enrolment	8
Key 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
Key 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)
Date of first enrolment	01/08/2008
Date of final enrolment	01/02/2010

Locations

Countries of recruitment

Germany

Study participating centre

University Leipzig

Leipzig
04103
Germany

Sponsor information

University of Leipzig (Germany)
University/education

c/o Prof. Hans Ludger Tillmann
Medical clinic II
Philipp Rosenthal Str. 27
Leipzig
04103
Germany

Phone	+49 (0)341 9712226
Email	Hans.Tillmann@medizin.uni-leipzig.de
Website	http://www.uni-leipzig.de/
"ROR"	https://ror.org/03s7gtk40

Funders

Funder type

Industry

Biotest AG (Germany)

No information available

Sanofi Pasteur MSD GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			21/04/2020	No	No

Editorial Notes

21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.