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: Bodsworth NJ, Cooper DA, Donovan B. The influence of human immunodeficiency virus type 1 infection on the development of the hepatitis B virus carrier state. J Infect Dis. 1991 May;163(5):1138-40. Sinicco A, Raiteri R, Sciandra M, Bertone C, Lingua A, Salassa B, Gioannini P. Coinfection and superinfection of hepatitis B virus in patients infected with human immunodeficiency virus: no evidence of faster progression to AIDS. Scand J Infect Dis. 1997;29(2):111-5. 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. Keet IP, van Doornum G, Safary A, Coutinho RA. Insufficient response to hepatitis B vaccination in HIV-positive homosexual men. AIDS. 1992 May;6(5):509-10. Wong EK, Bodsworth NJ, Slade MA, Mulhall BP, Donovan B. Response to hepatitis B vaccination in a primary care setting: influence of HIV infection, CD4+ lymphocyte count and vaccination schedule. Int J STD AIDS. 1996 Nov-Dec;7(7):490-4. Bruguera M, Cremades M, Salinas R, Costa J, Grau M, Sans J. Impaired response to recombinant hepatitis B vaccine in HIV-infected persons. J Clin Gastroenterol. 1992 Jan;14(1):27-30. Rey D, Krantz V, Partisani M, Schmitt MP, Meyer P, Libbrecht E, Wendling MJ, Vetter D, Nicolle M, Kempf-Durepaire G, Lang JM. Increasing the number of hepatitis B vaccine injections augments anti-HBs response rate in HIV-infected patients. Effects on HIV-1 viral load. Vaccine. 2000 Jan 18;18(13):1161-5. Sasaki Md, Foccacia R, de Messias-Reason IJ. Efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant for hepatitis B virus in patients with HIV infection. Vaccine. 2003 Nov 7;21(31):4545-9. Wilson CM, Ellenberg JH, Sawyer MK, Belzer M, Crowley-Nowick PA, Puga A, Futterman DC, Peralta L; Adolescent Medicine HIV/AIDS Research Network. Serologic response to hepatitis B vaccine in HIV infected and high-risk HIV uninfected adolescents in the REACH cohort. Reaching for Excellence in Adolescent Care and Health. J Adolesc Health. 2001 Sep;29(3 Suppl):123-9. Rutstein RM, Rudy B, Codispoti C, Watson B. Response to hepatitis B immunization by infants exposed to HIV. AIDS. 1994 Sep;8(9):1281-4. Scolfaro C, Fiammengo P, Balbo L, Madon E, Tovo PA. Hepatitis B vaccination in HIV-1-infected children: double efficacy doubling the paediatric dose. AIDS. 1996 Sep;10(10):1169-70. Saltoğlu N, Inal AS, Tasova Y, Kandemir O. Comparison of the accelerated and classic vaccination schedules against Hepatitis B: three-week Hepatitis B vaccination schedule provides immediate and protective immunity. Ann Clin Microbiol Antimicrob. 2003 Nov 17;2:10. Marchou B, Picot N, Chavanet P, Auvergnat JC, Armengaud M, Devilliers P, Cerisier JE, Marié FN, Excler JL. Three-week hepatitis B vaccination provides protective immunity. Vaccine. 1993 Nov;11(14):1383-5. Nothdurft HD, Dietrich M, Zuckerman JN, Knobloch J, Kern P, Vollmar J, Sänger R. A new accelerated vaccination schedule for rapid protection against hepatitis A and B. Vaccine. 2002 Jan 15;20(7-8):1157-62. Wright NM, Campbell TL, Tompkins CN. Comparison of conventional and accelerated hepatitis B immunisation schedules for homeless drug users. Commun Dis Public Health. 2002 Dec;5(4):324-6.
Starting date: April 2004
Last updated: June 1, 2010
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