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Hepatitis B Vaccination in HIV-infected Persons

Information source: Erasmus Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Hepatitis B

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

Phase: Phase 4

Status: Completed

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
Theodora EM de Vries-Sluijs, MD, Principal Investigator, Affiliation: Erasmus Medical Center

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.

Clinical Details

Official title: Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Measurement of anti-Hbs titer after completing hepatitis B vaccination.

Secondary outcome: To compare response and compliance between two vaccination schedules: short and standard

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV positive

- Negative for HBsAg and anti-HBc

- 18 years or older

Exclusion Criteria:

- previous Hepatitis B vaccination

- current opportunistic infection

Locations and Contacts

Erasmus Medical Center, Rotterdam 3000 CA, Netherlands
Additional Information

Related publications:

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Ockenga J, Tillmann HL, Trautwein C, Stoll M, Manns MP, Schmidt RE. Hepatitis B and C in HIV-infected patients. Prevalence and prognostic value. J Hepatol. 1997 Jul;27(1):18-24.

Lemon SM, Thomas DL. Vaccines to prevent viral hepatitis. N Engl J Med. 1997 Jan 16;336(3):196-204. Review.

Carne CA, Weller IV, Waite J, Briggs M, Pearce F, Adler MW, Tedder RS. Impaired responsiveness of homosexual men with HIV antibodies to plasma derived hepatitis B vaccine. Br Med J (Clin Res Ed). 1987 Apr 4;294(6576):866-8.

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Starting date: April 2004
Last updated: June 1, 2010

Page last updated: August 20, 2015

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