NCT00230061

Hepatitis B Vaccination in HIV-infected Persons

Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml

Timeline

• Start date: 2004-04-01
• Primary completion: 2008-05-01
• Completion: 2010-02-01
• First posted: 2005-09-30
• Last updated: 2010-06-02

Locations

1 site across 1 country: Netherlands