Hepatitis B virus vaccine in chronic kidney disease: Improved immunogenicity by adjuvants? A meta-analysis of randomized trials

Vaccine

Volumn 30, Issue 13, 2012, Pages 2295-2300

  Fabrizi, Fabrizio ^a   Dixit, Vivek ^b   Messa, Piergiorgio ^a   Martin, Paul ^b  

^a FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^b UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

Adjuvants; Chronic kidney disease; Dialysis; Hepatitis B virus; Meta analysis; Vaccine

Indexed keywords

HEPATITIS B VACCINE; IMMUNOLOGICAL ADJUVANT; RECOMBINANT VACCINE;

ARTICLE; CHRONIC KIDNEY DISEASE; DRUG EFFICACY; DRUG FEVER; DRUG SAFETY; FATIGUE; HEPATITIS B; HUMAN; IMMUNE RESPONSE; IMMUNITY; IMMUNOGENICITY; INJECTION SITE PAIN; META ANALYSIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ADJUVANTS, IMMUNOLOGIC; ADULT; AGED; FEMALE; HEPATITIS B; HEPATITIS B ANTIBODIES; HEPATITIS B VACCINES; HEPATITIS B VIRUS; HUMANS; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RENAL DIALYSIS; RENAL INSUFFICIENCY, CHRONIC; TREATMENT OUTCOME; VACCINES, SYNTHETIC; YOUNG ADULT;

EID: 84863397336     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.01.064     Document Type: Article

References (45)

1. Burdick R.A., Bragg-Gresham J.L., Woods J.D., Hedderwick S.A., Kurokawa K., Combe C., et al. Patterns of hepatitis B prevalence and seroconversion in hemodialysis units from three continents: the DOPPS. Kidney Int 2003, 63:2222-2229.
2. Finelli L., Miller J.T., Tokars J.I., Alter M.J., Arduino M.J. National surveillance of dialysis-associated diseases in the United States, 2002. Semin Dial 2005, 18:52-61.
3. Thompson N.D., Perz J.F., Moorman A.C., Holmberg S.D. Nonhospital health care-associated hepatitis B and C virus transmission: United States, 1998-2008. Ann Intern Med 2009, 150:33-39.
4. Paniaqua R., Villasis-Keever A., Prado-Uribe C., Ventura-Garcia M., Alcantara-Ortega G., Ponce de Leon S., et al. Elevated prevalence of hepatitis B in Mexican hemodialysis patients. Arch Med Res 2010, 41:251-254.
5. Beltran M., Navas M., Arbelaez M., Donado J., Jaramillo S., De La Hoz F., et al. Seroprevalence of hepatitis B virus and human immunodeficiency virus infection in a population of multiply-transfused patients in Colombia. Biomedica 2009, 29:232-243.
6. Martin P., Friedman L.S. Chronic viral hepatitis and the management of chronic renal failure. Kidney Int 1995, 47:1231-1241.
7. Rangel M., Coronado V., Euler G., Strikas R. Vaccine recommendations for patients on chronic dialysis. Semin Dial 2002, 13:101-107. for the Advisory Committee on Immunization Practices and the American Academy of Pediatrics.
8. Marangi A., Giordano R., Montanaro A., De Padova F., Schiavone M., Dongiovanni G., et al. Hepatitis B virus infection in chronic uraemia: long-term follow-up of a two-step integrated protocol of vaccination. Am J Kidney Dis 1994, 23:537-542.
9. DaRoza G., Loewen A., Djurdjev O., Love J., Kempston C., Burnett S., et al. Stage of chronic kidney disease predicts seroconversion after hepatitis B immunization: earlier is better. Am J Kidney Dis 2003, 42:1184-1192.
10. Donati D., Gastaldi L. Controlled trial of thymopentin in hemodialysis patients who fail to respond to hepatitis B vaccination. Nephron 1988, 50:133-136.
11. Verkade M., van de Wetering J., Klepper M., Vaessen L., Weimar W., Betjes M. Peripheral blood dendritic cells and GM-CSF as an adjuvant for hepatitis B vaccination in hemodialysis patients. Kidney Int 2004, 66:614-621.
12. Tong N., Beran S., Kee S., Miguel J., Sanchez C., Bayas J., et al. A new adjuvant improves the immune response to hepatitis B vaccine in hemodialysis patients. Kidney Int 2008, 73:856-862.
13. Poynard T., Conn H.O. The retrieval of randomised clinical trials in liver diseases from the medical literature: a comparison of MEDLARS and manual methods. Control Clin Trials 1985, 6:271-279.
14. DerSimonian R., Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986, 7:177-188.
15. Higgins J.P.T., Thompson S.G., Deeks J., Altman D. Measuring inconsistency in meta-analyses. Br Med J 2003, 327:557-560.
16. Petitti D.B. Approaches to heterogeneity in meta-analysis. Stat Med 2001, 20:3625-3633.
17. Galbraith R.F. A note on graphical presentation of estimated odds ratios from several clinical trials. Stat Med 1988, 7:889-894.
18. Klein S., Simes J., Blackburn G.L. Total parenteral nutrition and cancer clinical trial. Cancer 1986, 58:1378-1386.
19. Quiroga J., Castillo I., Porres J., Casado S., Saez F., Martinez M., et al. Recombinant-gamma interferon as adjuvant to hepatitis B vaccine in hemodialysis patients. Hepatology 1990, 12:661-663.
20. Jungers P., Devillier P., Salomon H., Cerisier J., Courouce A. Randomised placebo-controlled trial of recombinant interleukin-2 in chronic uraemic patients who are non-responders to hepatitis B vaccine. Lancet 1994, 344:856-857.
21. Evans T., Schiff M., Graves B., Agosti J., Barritt M., Garner D., et al. The safety and efficacy of GM-CSF as an adjuvant in hepatitis B vaccination of chronic hemodialysis patients who have failed primary vaccination. Clin Nephrol 2000, 54:138-142.
22. Perez-Garcia R., Perez-Garcia A., Verbeelen D., Bernstein E., Villarrubia V., Alvarez-Mon M. AM3 (Inmunoferon) as an adjuvant to hepatitis B vaccination in hemodialysis patients. Kidney Int 2002, 61:1845-1852.
23. Singh N., Mandal S., Thankur A., Kapoor D., Anurafha S., Prakash A., et al. Efficacy of GM-CSF as an adjuvant to hepatitis B vaccination in patients with chronic renal failure-results of a prospective, randomized trial. Renal Failure 2003, 25:255-266.
24. Tong N., Beran J., Kee S., Miguel J., Sanchez C., Bayas J., et al. Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Kidney Int 2005, 68:2298-2303.
25. Sali S., Alavian S., Hajarizadeh B. Effect of levamisole supplementation on hepatitis B virus vaccination response in hemodialysis patients. Nephrology 2008, 13:376-379.
26. Miquilena-Colina M., Lozano-Rodriguez T., Garcia-Pozo L., Saez A., Rizza P., Capone I., et al. Recombinant interferon-alpha 2b improves immune rersponse to hepatitis B vaccination in haemodialysis patients. Results of a randomised clinical trial. Vaccine 2009, 27:5654-5660.
27. Tielemans C., Vlasak J., Kosa D., Billiouw J., Verpooten G., Mezei I., et al. Immunogenicity and safety of an investigational AS02v-adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: results of two open, randomized, comparative trials. Vaccine 2011, 29:1159-1166.
28. American Society of Transplantation Guidelines for vaccination of solid organ transplant candidates and recipients. Am J Transplant 2004, 4(Suppl. 10):160-163.
29. Girndt M., Kohler H. Hepatitis B virus infection in hemodialysis patients. Semin Nephrol 2002, 22:340-350.
30. Pesanti E.L. Immunologic defects and vaccination in patients with chronic renal failure. Infect Dis Clin North Am 2001, 15:813-821.
31. Jadoul M., Goubau P. Is anti-hepatitis B virus immunization successful in elderly hemodialysis patients?. Clin Nephrol 2002, 58:301-304.
32. Stevens C., Alter H., Taylor P., Zang E., Harley E., Szmuness W. Hepatitis B vaccine in patients receiving hemodialysis. N Engl J Med 1984, 311:496-501. The Dialysis Vaccine Trial Study Group.
33. Fernandez E., Betru M.A., Gomes R., Montoliu J. Response to the hepatitis B virus in haemodialysis patients: influence of malnutrition and its importance as a risk factor for morbidity and mortality. Nephrol Dial Transplant 1996, 11:1559-1563.
34. Navarro J., Teruel J., Mateos M., Marcen R., Ortuno J. Antibody level after hepatitis B vaccination in hemodialysis patients: influence of hepatitis C virus infection. Am J Nephrol 1996, 16:95-97.
35. Ahuja T.S., Kumar S., Mansoury H., Rodriguez H., Kuo Y.F. Hepatitis B vaccination in human immunodeficiency virus-infected adults receiving hemodialysis. Kidney Int 2005, 67:1136-1141.
36. Alavian S.M., Tabatabaei S. The effect of diabetes mellitus on immunological response to hepatitis B virus vaccine in individuals with chronic kidney disease: a meta-analysis of clinical trials. Vaccine 2010, 28:3773-3777.
37. Sennesael J., van der Niepen P., Verbeelen D.L. Treatment with recombinant human erythropoietin increases antibody titers after hepatitis B vaccination in dialysis patients. Kidney Int 1991, 40:121-128.
38. Pol S., Legendre C., Mattlinger B., Berthelot P., Krein H. Genetic basis of nonresponse to hepatitis B vaccine in hemodialysis patients. J Hepatol 1990, 11:385-387.
39. Jibani M., Heptonstall J., Walker A.M., Bloodworth L., Howard A. Hepatitis B immunization in UK renal units: failure to put policy into practice. Nephrol Dial Transplant 1994, 9:1765-1768.
40. Weinstein T., Chagnac A., Boaz M., et al. Improved immunogenicity of a novel third-generation recombinant hepatitis B vaccine in patients with end-stage renal disease. Nephron Clin Pract 2004, 97:67-72.
41. Haubitz M., Ehderling G., Beigel A., Heuer U., Hemmerling A.E., Thoma H.A. Clinical experience with a new recombinant hepatitis B - vaccine in previous nonresponders with chronic renal insufficiency. Clin Nephrol 1996, 45:180-184.
42. Surquin M., Tielemans C., Kulcsar I., Ryba M., Voros P., Mat O., et al. Rapid enhanced, and persistent protection of patients with renal insufficiency by AS02v-adjuvanted hepatitis B vaccine. Kidney Int 2010, 77:247-255.
43. Wu T., Li Y., Bian Z., Liu G., Moher D. Randomized trials published in some Chinese journals: how many are randomized?. Trials 2009, 10:46.
44. Moher D., Pham B., Jones A., Cook D.J., Jadad A.R., Moher M., et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?. Lancet 1998, 352:609-613.
45. Miller E.R., Alter M.J., Tokars J.L. Protective effect of hepatitis B vaccine in chronic hemodialysis patients. Am J Kidney Dis 1999, 33:356-360.