Status:
COMPLETED
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
Lead Sponsor:
Henogen
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of...
Detailed Description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 3 visits and blood samples will taken at each of...
Eligibility Criteria
Inclusion
- Subjects whom the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A male or female subject 15 years of age or older at the time of the study entry.
- Written informed consent obtained from the subject/ subject's parents or guardians.
- Pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Pre-dialysis patients is defined as a subject with a documented creatinine clearance of les or equal to 30 ml/min.
- Seronegative for anti-HBc antibodies and for HBsAg at screening.
- Documented previous hepatitis B vaccination with one full primary course of licensed vaccine (the cumulative dose for primary vaccination is at least 160 mg of hepatitis B vaccine) with or without subsequent boosters. The last dose should have been administered at least three months before the planned dose of study vaccine in this study.
- Documented response to previous hepatitis B vaccination (i.e. anti-HBs antibody concentrations ³ 10 mIU/ml after primary vaccination or after booster/s with licensed vaccine), but for whom there is a loss of anti-HBs antibody concentrations below 10 mIU/ml at the time of inclusion into the study. Patients who have antibody concentrations below 50 mIU/ml at the time of inclusion will also be recruited provided that this antibody concentration is less than half of the highest documented antibody response achieved after primary vaccination or booster/s. The interval between the blood sample corresponding to the documented response and the hepatitis B vaccine dose received prior to this blood sample should be at least 25 days
- If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used medically-approved contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion
- Subjects who have participated in the HN014/HBV-001 or HN017/HBV-003 study
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the study vaccine administration, or planned use during the study period.
- Use of any registered vaccine within 7 days preceding the study vaccine administration.
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within six months.
- Use of immunoglobulins within six months preceding the first study vaccination.
- Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
- Any confirmed or suspected human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral/ axillary temperature \< 37.5°C (or 37 °C in Czech Republic).
- Oral/axillary temperature equal or superior to 37.5 °C (or 37 °C in Czech Republic).
- Pregnant or lactating female
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00291980
Start Date
March 1 2006
End Date
October 1 2007
Last Update
August 28 2008
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
O.L.Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
2
RHMS La Madeleine ATH
Ath, Belgium, 7800
3
RHMS Clinique Louis Caty Baudour
Baudour, Belgium, 7331
4
Cliniques universitaires Saint Luc
Brussels, Belgium, 1200