Condition category
Infections and Infestations
Date applied
19/08/2008
Date assigned
09/10/2008
Last edited
09/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uni-leipzig.de/

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

Publication citations

Additional files

Editorial Notes