Hepatitis B Vaccination in HIV-infected Persons
Biological: HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.|
- Measurement of anti-Hbs titer after completing hepatitis B vaccination.
- To compare response and compliance between two vaccination schedules: short and standard
|Study Start Date:||April 2004|
|Study Completion Date:||February 2010|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230061
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3000 CA|
|Principal Investigator:||Theodora EM de Vries-Sluijs, MD||Erasmus Medical Center|