Clinical Trials

MainTitle

Hepatitis B Vaccination in HIV-infected Persons

This study has been completed
Sponsor
Erasmus Medical Center

Collaborator
Stichting Nuts Ohra

Information provided by (Responsible Party)
Erasmus Medical Center
ClinicalTrials.gov Identifier
NCT00230061

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

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
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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


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  

Keywords provided by Erasmus Medical Center:

HIV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
HIV Infections
Hepatitis B

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.