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Sponsors and Collaborators: |
Erasmus Medical Center Stichting Nuts Ohra |
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Information provided by: | Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT00230061 |
In this study we compare the efficacy of two different HBV-vaccination schedules in HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.
Condition | Intervention | Phase |
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HIV Infections Hepatitis B |
Biological: HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-Infected Persons. |
Estimated Enrollment: | 800 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | December 2007 |
It is known that HIV-infected persons are more prone to develop chronic hepatitis B infection when they get infected with this virus. After developing chronic hepatitis B these patients are more likely to get livercirrosis and hepatocellular carcinoma (Bodsworth et al.).
Hepatitis B vaccination is available and the vaccine is about 95% protective in preventing immunocompetent persons from developing chronic hepatitis B infection (Lemon). The response on this vaccin is less effective in HIV-infected persons (Carne et al.). Furthermore there is a compliance problem in the standard scheme.
In this study we compare the efficacy of two different HBV vaccination schedules in HIV-infected persons concerning immune response and compliance. A short schedule: t=0,1,3 weeks, in which there are good results concerning immune response and compliance in immunocompetent persons (Saltog et al.) and the standard schedule: t=0,1,6 months. Patients not immune at week 28 will be offered boostervaccination. This consists of double doses at t=0,1,2 months. 800 persons are needed to show non-inferiority with lower margin of 10% of the short schedule in comparison with the control group. Powercalculation is 80%. Randomization is stratified according to CD4 count(CD4 <200, 200-500, >500).
The hypothesis of the study is a better compliance and a comparable immune response in the short schedule, through which persons will be protected against hepatitis B in an early stage.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Erasmus Medical Center | |
Rotterdam, Netherlands, 3000 CA |
Principal Investigator: | Theodora EM de Vries-Sluijs, MD | Erasmus Medical Center |
Study ID Numbers: | SNO-T-07-102 |
Study First Received: | September 28, 2005 |
Last Updated: | October 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00230061 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
HIV |
Sexually Transmitted Diseases, Viral Liver Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis Virus Diseases |
Digestive System Diseases HIV Infections Sexually Transmitted Diseases Hepatitis B DNA Virus Infections Retroviridae Infections |
Liver Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Infection Hepadnaviridae Infections Immunologic Deficiency Syndromes |
Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Hepatitis B Lentivirus Infections DNA Virus Infections Retroviridae Infections |