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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
Stichting Nuts Ohra
Information provided by:
Erasmus Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis B Biological: HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/ml Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
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.
Study Start Date : April 2004
Primary Completion Date : May 2008
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Measurement of anti-Hbs titer after completing hepatitis B vaccination.

Secondary Outcome Measures :
  1. To compare response and compliance between two vaccination schedules: short and standard

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Erasmus Medical Center
Stichting Nuts Ohra
Principal Investigator: Theodora EM de Vries-Sluijs, MD Erasmus Medical Center


Responsible Party: Theodora EMS de Vries-Sluijs, ErasmusMC
ClinicalTrials.gov Identifier: NCT00230061     History of Changes
Other Study ID Numbers: SNO-T-07-102
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: June 2010

Keywords provided by Erasmus Medical Center:

Additional relevant MeSH terms:
Hepatitis A
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections