Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients

Liver Transplantation

Volumn 12, Issue 10, 2006, Pages 1489-1495

  Nevens, Frederik ^a   Zuckerman, Jane N ^b   Burroughs, Andrew K ^c   Jung, Maria Christina ^d   Bayas, José M ^e   Kallinowski, Birgit ^f   Rivas, Enrique Fraga ^g   Duvoux, Christophe ^h   Neuhaus, Peter ⁱ   Saliba, Faouzi ^j   Buti, Maria ^k   Zarski, Jean Pierre ^l   Pons, Fernando ^m   Vanlemmens, Claire ⁿ   Hamtiaux, Virginie ^o   Stoffel, Michel ^o  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

^c ROYAL FREE HOSPITAL   (United Kingdom)

^d LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^e HOSPITAL CLÍNIC   (Spain)

^f Praxis for Gastroenterology and Oncology   (Germany)

^g HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^h HENRI MONDOR HOSPITAL   (France)

ⁱ Landesinstitut für Tropenmedizin   (Germany)

^j HÔPITAL PAUL BROUSSE   (France)

^k HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^l Servicio d'Hépato Gastro Entérologie   (France)

^m HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

ⁿ HÔpital Jean Minjoz   (France)

^o GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM SALT; HB AS 04; HEPATITIS B SURFACE ANTIBODY; HEPATITIS B VACCINE; PHOSPHORYL LIPID A; RECOMBINANT HEPATITIS B VACCINE;

ADULT; ALCOHOL LIVER CIRRHOSIS; ANTIBODY RESPONSE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REGIMEN; DRUG FEVER; DRUG SAFETY; EDEMA; ERYTHEMA; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEPATITIS B; HEPATITIS C; HUMAN; IMMUNOGENICITY; IMMUNOREACTIVITY; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PAIN; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADJUVANTS, IMMUNOLOGIC; ADULT; FEMALE; HEPATITIS B; HEPATITIS B ANTIBODIES; HEPATITIS B VACCINES; HUMANS; IMMUNIZATION, SECONDARY; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; TIME FACTORS;

EID: 33750126192     PISSN: 15276465     EISSN: 15276473     Source Type: Journal    
DOI: 10.1002/lt.20836     Document Type: Article

References (23)

1. Wachs ME, Amend WJ, Ascher NL, Bretan PN, Emond J, Lake JR, et al. The risk of transmission of hepatitis B from HBsAg(-), HBcAb(-), HBIgM(-) organ donors. Transplantation 1995;59:230-234.
2. Dickson RC, Everhart JE, Lake JR, Wei Y, Seaberg EC, Wiesner RH, et al. Transmission of hepatitis B by transplantation of livers from donors positive for antibody to hepatitis B core antigen. Gastroenterology 1997;113: 1668-1674.
3. Fabia R, Levy MF, Crippin J, Tillery W, Netto GJ, Aguanno J, et al. De novo hepatitis B infection after liver transplantation: source of disease, incidence and impact. Liver TranspI Surg 1998; 4:119-126.
4. De Villa V, Chen Y-S, Chen C-L. Hepatitis B core antibody positive grafts: recipient's risk. Transplantation 2003;75(3suppl):S49-53.
5. Kallinowski B, Benz C, Buchholz L, Stremmel W. Accelerated schedule of hepatitis B vaccination in liver transplant candidates. Transplant Proc 1998;30:797-799.
6. Stevens CE, Szmuness W, Goodman AI, Weseley SA, Fotino M. Hepatitis B vaccine: immune responses in hemodialysis patients. Lancet 1980;2:1211-1213.
7. Seaworth B, Drucker J, Starling J, Drucker R, Stevens C, Hamilton J. Hepatitis B vaccines in patients with chronic renal failure before dialysis. J Infect Dis 1988; 157:332-337.
8. Loinaz C, Ramon de Juanes J, Moreno Gonzalez E, Lopez A, Lumbreras C, Gomez R, et al. Hepatitis B vaccination results in 140 liver transplant recipients. Hepatogastroenterolgy 1997;44:235-238.
9. Engler S, Sauer P, Golling M, Klar EA, Benz C, Stremmel W, Kallinowski B. Immunogenicity of two accelerated hepatitis B vaccination protocols in liver transplant candidates. Eur J Gastroenterol Hepatol 2001;13:363-367.
10. Arslan M, Wiesner RH, Sievers C, Egan K, Zein NN. Double-dose accelerated hepatitis B vaccine in patients with end-stage liver disease. Liver Transpl 2001;4:314-320.
11. Degos F, Brechot C, Nalpas B, Duhamel G, Courouce AM, Tron F, Berthelot P. Hepatitis B vaccination and alcoholic cirrhosis. Lancet 1983;2:1498.
12. Schirren CA, Jung MC, Zachoval R, Diepolder H, Hoffmann R, Riethmuller G, Pape GR. Analysis of T cell activation pathways in patients with liver cirrhosis, impaired delayed hypersensitivity and other T cell-dependent functions. Clin Exp, Immunol 1997; 108:144-150.
13. Keeffe EB. Vaccination against hepatitis A and B in chronic liver disease. Viral Hepatitis Rev 1999;5:77-88.
14. Van Thiel DH. Vaccination of patients with liver disease: who, when and how. Liver TranspI Surg 1998;4:185-187.
15. Keeffe EB, Krause DS. Hepatitis B vaccination of patients with chronic liver disease. Liver Transpl Surg 1998;4:437-439.
16. Thoelen S, Van Damme, P, Mathei C, Lcroux-Roels G, Desombere I, Salary A, etal. Safety and immunogenicity of a hepatitis B vaccine formulated with a novel adjuvanted system. Vaccine 1998;16:708-714.
17. Boland G, Beran J, Lievens M., Sasadeusz S, Dentico P, Nothdurft H, et al. Safety and immurrogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04. Vaccine 2004;23:3216-320.
18. Carey W, Pimentel R, Westveer MK, Vogt D, Broughan T. Failure of hepatitis B immunization in liver transplant recipients: results of a prospective trial. Am J Gastroenterol 1990;85:1590-1592.
19. Van Thiel D, El-Ashmawy L, Love K, Gavaler J, Starzl T. Response to hepatitis B vaccination by liver transplant candidates. Dig Dis Sci 1992;37:1245-1249.
20. Clemente Ricote G, Perez Roldan F, Banares Canizares R, Vicario JL, Santos Castro L, Perez Marin C, Calleja Kempin J, et al. The response to hepatitis B vaccine prior to orthotopic liver transplantation. Rev Esp Enferm Dig 1995;87:516-520.
21. Sokal E, Ulla L, Otte JB. Hepatitis B vaccine response before and after transplantation in 55 extrahepatic biliary atresia children. Dig Dis Sci 1992;37:1250-1252.
22. Chalasani N, Smallwood G, Halcomb J, Fried MW, Boyer TD. Is vaccination against hepatitis B infection indicated in patients waiting for or after orthotopic liver transplantation. Liver Transpl Surg 1998;4:128-132.
23. Tong NK, Beran J, Kee SA, Miguel JL, Sanchez C, Bayas JM, et al. Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Kidney Int 2005;68:2298-2303.