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Hepatitis B Vaccination in HIV-infected Persons

This study has been completed.
Sponsor:
Collaborator:
Stichting Nuts Ohra
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00230061
First received: September 28, 2005
Last updated: June 1, 2010
Last verified: June 2010

September 28, 2005
June 1, 2010
April 2004
May 2008   (final data collection date for primary outcome measure)
Measurement of anti-Hbs titer after completing hepatitis B vaccination.
Same as current
Complete list of historical versions of study NCT00230061 on ClinicalTrials.gov Archive Site
To compare response and compliance between two vaccination schedules: short and standard
Same as current
Not Provided
Not Provided
 
Hepatitis B Vaccination in HIV-infected Persons
Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Hepatitis B
Biological: HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
February 2010
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV positive
  • Negative for HBsAg and anti-HBc
  • 18 years or older

Exclusion Criteria:

  • previous Hepatitis B vaccination
  • current opportunistic infection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00230061
SNO-T-07-102
Not Provided
Theodora EMS de Vries-Sluijs, ErasmusMC
Erasmus Medical Center
Stichting Nuts Ohra
Principal Investigator: Theodora EM de Vries-Sluijs, MD Erasmus Medical Center
Erasmus Medical Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP