Bivalent inactivated hepatitis a and recombinant hepatitis B vaccine

Expert Review of Vaccines

Volumn 6, Issue 6, 2007, Pages 891-902

  Beran, Jiri ^a,b  

^a UNIVERSITY HOSPITAL HRADEC KRALOVE   (Czech Republic)

^b Vaccination and Travel Medicine Centre   (Czech Republic)

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS A HEPATITIS B VACCINE; HEPATITIS A VACCINE; RECOMBINANT HEPATITIS B VACCINE;

ANTIBODY RESPONSE; CLINICAL TRIAL; DRUG EFFICACY; DRUG FORMULATION; DRUG MARKETING; DRUG SAFETY; HEPATITIS A; HEPATITIS A VIRUS; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INCIDENCE; PRIORITY JOURNAL; REVIEW; RISK FACTOR; VACCINATION; VIRUS TRANSMISSION;

ADOLESCENT; ADULT; CLINICAL TRIALS AS TOPIC; EUROPE; HEPATITIS A; HEPATITIS A VACCINES; HEPATITIS B; HEPATITIS B VACCINES; HUMANS; IMMUNIZATION SCHEDULE; UNITED STATES; VACCINES, COMBINED; VACCINES, SYNTHETIC; YOUNG ADULT;

EID: 37249063267     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/14760584.6.6.891     Document Type: Review

References (66)

1. Koff RS. Review article: vaccination and viral hepatitis - current status and future prospects. Aliment Pharmacol. Ther. 26(10), 1285-1292 (2007).
2. World Health Organization (WHO). Hepatitis A vaccines. Wkly Epidemiol. Rec. 75, 38-43 (2000).
3. Centers for Disease Control (CDC). Hepatitis A. In: Epidemiology and Prevention of Vaccine-Preventable Diseases (9th Edition). Atkinson W, Hamborsky J, McIntyre L, Wolfe S (Eds). Public Health Foundation, Washington DC, USA 193-206 (2006).
4. Centers for Disease Control (CDC). Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm. Rep. 55(RR-7), 1-23 (2006). • Immunization strategy against hepatitis A in the USA.
5. World Health Organization (WHO). WHO position paper on the use of hepatitis B vaccines. Wkly Epidemiol. Rec. 255-263 (2004).
6. Impfempfehlungen der ständigen impfkommission (STIKO) an RKI Epidemiologisches Bulletin Nr 2, Robert Koch Institut (2000).
7. Salisbury DM, Begg NT. Immunisation against infectious disease. London: HM Stationery Office 95-108 (1996).
8. Sezer S, Özdemir FN, Güz G et al. Factors influencing response to hepatitis B virus vaccination in hemodialysis patients. Transplant Proc. 32, 607 (2000).
9. Navarro JF, Teruel JL, Mateos ML, Marcen R, Ortuno J. Antibody level after hepatitis B vaccination in hemodialysis patients: influence of hepatitis C virus infection. Am. J. Nephrol. 16, 95 (1996).
10. Lemon SM, Binn LN. Serum neutralizing antibody response to hepatitis A virus. J. Infect. Dis. 148, 1033-1039 (1983).
11. WHO Expanded Programme on Immunization, Global Advisory Group. Wkly Epidemiol. Rec. 3, 11-16 (1992).
12. Safary A, Francis A. Over a decade of experience with a yeast recombinant hepatitis B vaccine. Vaccine 18, 57-67 (2000).
13. Germinario C, Lopalco PL, Chicanna M, Da Villa G. From hepatitis B to hepatitis A and B prevention: the Puglia (Italy) experience. Vaccine 18(Suppl. 1), S83-S85 (2000).
14. Dominguez A, Salleras L, Carmona G, Batalla J. Effectiveness of a mass hepatitis A vaccination program in preadolescents. Vaccine 21(7-8), 698-701 (2003).
15. Dagan R. Update from Israel, the first country to adopt hepatitis A universal immunization program. Proceedings of the 3rd World Congress Pediatric Infectious Diseases, Santiago, Chile, November 19-23 (2002).
16. Keystone JS, Hershey JH. The underestimated risk of hepatitis A and hepatitis B: benefits of an accelerated vaccination schedule. Int. J. Infect. Dis. (2007) DOI:10.1016/j.ijid.2007.04.012.
17. Van Damme P, Van Herck K. A review of the efficacy, immunogenicity and tolerability of a combined hepatitis A and B vaccine. Expert Rev. Vaccines 33, 249-267 (2004).
18. Thoelen S, Van Damme P, Leentvaar-Kuypers A et al. The first combined vaccine against hepatitis A and B: an overview. Vaccine 17(13-14), 1657-1662 (1999). •• Summary of first key Twinrix™ clinical trials.
19. Joines RW, Blatter M, Abraham B et al. A prospective, randomized, comparative US trial of a combination hepatitis A and B vaccine (Twinrix) with corresponding monovalent vaccines (Havrix and Engerix-B) in adults. Vaccine 19(32), 4710-4719 (2001).
20. Van Damme P, Van Herck K. A review of the long-term protection after hepatitis A and B vaccination. Travel Med. Infect. Dis. 5, 79-84 (2007).
21. Connor BA, Blatter MM, Beran J, Zou B, Trofa AF. Rapid and sustained immune response against hepatitis A and B achieved with combined vaccine using an accelerated schedule. J. Travel Med. 14(1), 9-15 (2007). •• Latest published trial with Twinrix accelerated immunization schedule.
22. Hohler T, Groeger-Bicanic G, Hoet B, Stoffel M. Antibody persistence and immune memory elicited by combined hepatitis A and B vaccination in older adults. Vaccine 25, 1503-1508 (2007). •• Factors influencing immunogenicity and persistence of antibodies after Twinrix immunization.
23. Wolters B, Junge U, Dziuba S, Roggendorf M. Immunogenicity of combined hepatitis A and B vaccine in elderly persons. Vaccine 21(25-26), 3623-3628 (2003). • Age as a factor influencing immunogenicity. Twinrix evaluated retrospectively.
24. Nothdurft HD, Aumuller H, Aumuller R et al. A breakthrough case of hepatitis A disease following a full vaccination schedule of three doses of a combined hepatitis A and B vaccine. Vaccine 22, 592-593 (2004). • Age as a factor influencing immunogenicity. Twinrix evaluated retrospectively.
25. Van Damme P, Van Herck K, Van der Wielen M. Combined hepatitis A and B vaccine in elderly. Vaccine 22, 303-304 (2004). • Age as a factor influencing immunogenicity. Twinrix evaluated retrospectively.
26. Van der Wielen M, Van Damme P, Chlibek R, Smetana J, von Sonnenburg F. Hepatitis A/B vaccination of adults over 40 years old: comparison of three vaccine regimens and effect of influencing factors. Vaccine 24, 5509-5515 (2006). •• Factors influencing immunogenicity after Twinrix immunization.
27. Abraham B, Baine Y, De-Clercq N et al. Magnitude and quality of antibody response to a combination hepatitis A and hepatitis B vaccine. Antiviral Res. 53(1), 63-73 (2002). •• Persistence of antibodies after 10 years from Twinrix vaccination.
28. Höhler T, Reuss E, Evers N et al. Differential genetic determination of immune responsiveness to hepatitis B surface antigen and to hepatitis A virus: a vaccination study in twins. Lancet 360(9338), 991-995 (2002).
29. Van Herck K, Leroux-Roels G, Van Damme P, Srinivasa K, Hoet B. Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Med. Infect. Dis. 5, 171-175 (2007).
30. Van Damme P, Van Herck K, Banatvala JE. Do we need hepatitis A booster vaccinations? J. Travel Med. 11(30), 179-180 (2004).
31. Van Damme P, Banatvala J, Fay O et al. International Consensus Group on Hepatitis A Virus Immunity: hepatitis A booster: is there a need? Lancet 362, 1065-1071 (2003). •• No necessity for booster after complete immunization against hepatitis A.
32. Banatvala JE, Van Damme P. Hepatitis B vaccine - do we need boosters? J. Viral Hepat. 10, 1-6 (2003). •• No necessity for booster after complete immunization against hepatitis B.
33. Banatvala J, Kane M, Da Villa G et al. European Consensus Group on Hepatitis B Immunity. Are booster immunizations needed for lifelong hepatitis B immunity? Lancet 355, 561-565 (2000).
34. Van Damme P, Van Herck K. A review of the long-term protection after hepatitis A and B vaccination. Travel Med. Infect. Dis. 5, 79-84 (2007).
35. Beran J. Combined two-dose hepatitis A and B vaccine (AmBirix). Drugs 63(2), 214-215 (2003).
36. Diaz-Mitoma F, Law B, Parsons J. A combined vaccine against hepatitis A and B in children and adolescents. Pediatr. Infect. Dis. J. 18, 109-114 (1999).
37. Van Damme P, Leroux-Roels G, Law B et al. Long-term persistence of antibodies induced by vaccination and safety follow-up, with the first combined vaccine against hepatitis A and B in children and adults. J. Med. Virol. 65, 6-13 (2001). • Persistence of antibodies after Twinrix pediatric vaccination.
38. Van der Wielen M, Van Damme P, Collard F. A two dose schedule for combined hepatitis A and hepatitis B vaccination in children aged one to eleven years. Pediatr. Infect. Dis. J. 19(9), 848-853 (2000).
39. Burgess MA, Rodger AJ, Waite SHA, Collard F. Comparative immunogenicity and safety of two dosing schedules of a combined hepatitis A and B vaccine in healthy adolescent volunteers: an open, randomized study. Vaccine 19, 4835-4841 (2001). • Study evaluated AmBirix™ schedule 0, 1 and 6 months and 0, 1 and 12 months.
40. Levie K, Beran J, Collard F, Nguyen C. Long term (24 months) follow-up of a hepatitis A and B vaccine, comparing a two and three dose schedule in adolescents aged 12-15 years. Vaccine 20, 579-2584 (2002). • Comparative study of Ambirix versus Twinrix Pediatric.
41. Roberton D, Marshall H, Nolan TM et al. Reactogenicity and immunogenicity profile of a two-dose combined hepatitis A and B vaccine in 1-11-year-old children. Vaccine 23, 5099-5105 (2005). • Study evaluated AmBirix in children aged 1-11 years.
42. Kurugöl Z, Mutlubas F, Ozacar T. A two-dose schedule for combined hepatitis A and B vaccination in children aged 6-15 years. Vaccine 23(22), 2876-2880 (2005).
43. Van Damme P, Van Herck K. A review of the efficacy, immunogenicity and tolerability of a combined hepatitis A and B vaccine. Expert Rev. Vaccines 3(3), 249-267 (2004). •• Critical review of Twinrix.
44. Murdoch DL, Goa K, Figgitt DP. Combined hepatitis A and B vaccines: a review of their immunogenicity and tolerability. Drugs 63(23), 2625-2649 (2003). • Review of Twinrix and AmBirix.
45. Jarvis B, Figgitt DP. Combined two-dose hepatitis A and B vaccine (AmBirix). Drugs 63(2), 207-213 (2003). •• Review of AmBirix data.
46. Loscher T, Keystone JS, Steffen R. Vaccination of travellers against hepatitis A and B. J. Travel Med. 6(2), 107-114 (1999).
47. Steffen R. Immunization against Hepatitis A and Hepatitis B infections. J. Travel Med. 8(Suppl. 1), S9-S16 (2001).
48. Keefe E. Hepatitis A in patients with chronic liver disease - severity of illness and prevention with vaccination. J. Viral Hepat. 7(Suppl. 1), 15-17 (2000).
49. Pramoolsinsap CJ. Acute hepatitis A and acquired immunity to hepatitis A virus in hepatitis B virus (HBV) carriers and in HBV- or Hepatitis C virus-related chronic liver diseases in Thailand. J. Viral Hepat. 7(Suppl. 1), 11-12 (2000).
50. Genton B, D'Acremont V, Furrer HJ, Hatz C, Loutan L. Hepatitis A vaccines and the elderly. Travel Med. Infect. Dis. 4(6), 303-312 (2006).
51. Baral S, Sherman SG, Millson P, Beyrer C. Vaccine immunogenicity in injection drug users: a systematic review. Lancet 7(10), 667-674 (2007).
52. Yoneyama T, Kiyohara T, Shimasaki N et al. Rapid and real-time detection of hepatitis A virus by reverse transcription loop-mediated isothermal amplification assay. J. Virol. Methods 145(2), 162-168 (2007).
53. Kafatos G, Anastassopoulou C, Nardone A et al. The European Sero-Epidemiology Network 2: standardization of assay results for hepatitis B virus. J. Viral Hepat. 14(4), 260-268 (2007).
54. European Consensus Group on Hepatitis B Immunity. Are booster immunisations needed for lifelong hepatitis B immunity ?. Lancet 355, 561-565 (2000).
55. Van Damme P, Banatvala J, Fay O et al. Hepatitis A booster vaccination: is there a need? Lancet 362, 1065-1071 (2003).
56. Mansoor OD, Salama P. Should hepatitis B vaccine be used for infants? Expert Rev. Vaccines 61, 29-33 (2007).
57. Nothdurft HD, Zuckerman J, Stoffel M, Dieussaert I, Van Damme P. Accelerated vaccination schedules provide protection against hepatitis A and B in last-minute travelers. J. Travel Med. 11, 260-261 (2004). • Data from Twinrix accelerated immunization schedule.
58. Van Herck K, Van Damme P, Collard F, Thoelen S. Two-dose combined vaccination against hepatitis A and B in healthy subjects aged 11-18 years. Scand. J. Gastroenterol. 34(12), 1236-1240 (1999).
59. Van Damme P, Vellinga A. Epidemiology of hepatitis B and C in Europe. Acta Gastroenterol. Belg. 61(2), 175-182 (1998).
60. Mast EE, Weinbaum CM, Fiore AE et al. Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of adults. MMWR Recomm. Rep. 55(RR-16), 1-33 (2006). • Immunization strategy against hepatitis B in the USA.
61. WHO. Hepatitis B fact sheet www.who.int/mediacentre/factsheets/fs204/en/
62. WHO. Number of countries introduced hepatitis B vaccine and global infant hepatitis B coverage, 1989-2005 www.who.int/immunization_monitoring/data/ SlidesGlobalImmunization.pdf
63. Twinrix Adult ™ prescribing information http://fda.gov/cber/label/ hahbgsk032807LB.pdf
64. Twinrix Adult ™ summary of product characteristics http://emea.europa.eu/humandocs/Humans/EPAR/twinrixadult/twinrixadult.htm
65. Twinrix Paediatric ™ summary of product characteristics http://emea.europa.eu/humandocs/Humans/EPAR/twinrixpaediatric/twinrixpaediatric. htm
66. AmBirix ™ summary of product characteristics http://emea.europa.eu/ humandocs/Humans/EPAR/ambirix/ambirix.htm