Hepatitis B Vaccination in HIV-infected Persons
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|ClinicalTrials.gov Identifier: NCT00230061|
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : June 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Hepatitis B||Biological: HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||February 2010|
- Measurement of anti-Hbs titer after completing hepatitis B vaccination.
- To compare response and compliance between two vaccination schedules: short and standard
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230061
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3000 CA|
|Principal Investigator:||Theodora EM de Vries-Sluijs, MD||Erasmus Medical Center|