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 immunisatio

Phase 2

Completed

• Conditions: Hepatitis B immunisation; Infections and Infestations; Acute hepatitis B

• Registration Number: ISRCTN84821453
• Lead Sponsor: niversity of Leipzig (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-09
• Study Completion: 2010-02-01
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified