Clinical trial NCT00230061: Hepatitis B Vaccination in HIV-infected Persons
Official title: Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Hepatitis B
Keywords: HIV
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Nuts Ohra
First posted: 2005-09-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* previous Hepatitis B vaccination
* current opportunistic infection

Primary outcomes:
measure: Measurement of anti-Hbs titer after completing hepatitis B vaccination.
Secondary outcomes:
measure: To compare response and compliance between two vaccination schedules: short and standard
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Theodora EM de Vries-Sluijs, MD
role: PRINCIPAL_INVESTIGATOR
References:
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