Clinical Trials


Hepatitis B Vaccination in HIV-infected Persons

This study has been completed
Erasmus Medical Center

Stichting Nuts Ohra

Information provided by (Responsible Party)
Erasmus Medical Center Identifier

First received: September 28, 2005
Last updated: June 1, 2010
Last Verified: June 2010
History of Changes


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
HIV Infections
Hepatitis B

Biological : HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures

  • Measurement of anti-Hbs titer after completing hepatitis B vaccination.
Secondary Outcome Measures:
  • To compare response and compliance between two vaccination schedules: short and standard

Enrollment: 800
Study Start Date: April 2004
Study Completion Date: February 2010
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

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.



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria:

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

Exclusion Criteria:
  • previous Hepatitis B vaccination
  • current opportunistic infection

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT00230061


Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA

Sponsors and Collaborators

Erasmus Medical Center
Stichting Nuts Ohra


Principal Investigator: Theodora EM de Vries-Sluijs, MD Erasmus Medical Center
More Information

More Information

Responsible Party: Theodora EMS de Vries-Sluijs, ErasmusMC Identifier: NCT00230061   History of Changes  
Other Study ID Numbers: SNO-T-07-102  
Study First Received: September 28, 2005  
Last Updated: June 1, 2010  

Keywords provided by Erasmus Medical Center:


Additional relevant MeSH terms:
Hepatitis A
HIV Infections
Hepatitis B processed this data on July 20, 2018
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