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
  Purpose

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
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.

Resource links provided by NLM:


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

Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230061

Locations
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
Erasmus Medical Center
Stichting Nuts Ohra
Investigators
Principal Investigator: Theodora EM de Vries-Sluijs, MD Erasmus Medical Center
  More Information

Publications:

Responsible Party: Theodora EMS de Vries-Sluijs, ErasmusMC
ClinicalTrials.gov Identifier: NCT00230061     History of Changes
Other Study ID Numbers: SNO-T-07-102
Study First Received: September 28, 2005
Last Updated: June 1, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
HIV

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

ClinicalTrials.gov processed this record on July 29, 2014