Hepatitis B Vaccination in HIV-infected Persons

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230061
• Other study ID #: SNO-T-07-102
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2005
• Last updated: June 1, 2010
• Start date: April 2004
• Est. completion date: February 2010

Study information

• Verified date: June 2010
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 2010
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV positive

• Negative for HBsAg and anti-HBc

• 18 years or older

Exclusion Criteria:

• previous Hepatitis B vaccination

• current opportunistic infection

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Stichting Nuts Ohra

Country where clinical trial is conducted

Netherlands, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Saltoglu 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of anti-Hbs titer after completing hepatitis B vaccination.
Secondary	To compare response and compliance between two vaccination schedules: short and standard