Skip to main content Accessibility help
×
Home

Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006

  • P. JORGENSEN (a1) (a2), C. POETHKO-MÜLLER (a3), W. HELLENBRAND (a1), W. JILG (a4), W. THIERFELDER (a3), C. MEYER (a1), M. AN DER HEIDEN (a1), M. SCHLAUD (a3) and D. RADUN (a1)...

Summary

The success of childhood vaccination against hepatitis B relies on persistence of immunity into adolescence and adulthood. In 2000, two hexavalent vaccines with a hepatitis B component (Hexavac®, Infanrix hexa®) were introduced in Germany. Hexavac was withdrawn in 2005 amidst concerns about its long-term hepatitis B protection. We compared hepatitis B surface antibody (anti-HBs) levels in children fully vaccinated with Hexavac or Infanrix hexa (n=477) in a secondary data analysis of a large cross-sectional health survey in Germany. On average 2·4 years after vaccination, 25·3% of Hexavac vaccinees had anti-HBs levels <10 mIU/ml (95% CI 19·0–32·8) compared to 4·7% of Infanrix hexa vaccinees (95% CI 2·4–8·9). These findings suggest that short-term hepatitis B immunogenicity in Hexavac vaccinees may also be weaker. Further studies are warranted to assess whether Hexavac vaccinees should be re-vaccinated or receive a booster vaccination before these birth cohorts reach adolescence.

  • View HTML
    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006
      Available formats
      ×

      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006
      Available formats
      ×

      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006
      Available formats
      ×

Copyright

Corresponding author

*Author for correspondence: Dr D. Radun, M.Sc., Department for Infectious Disease Epidemiology, Robert Koch Institute, DGZ-Ring 1, 13086 Berlin, Germany. (Email: RadunD@rki.de)

References

Hide All
1.Floreani, A, et al. Long-term persistence of anti-HBs after vaccination against HBV: an 18 year experience in health care workers. Vaccine 2004; 22: 608611.
2.European Consensus Group on Hepatitis B Immunity. Are booster immunisations needed for lifelong hepatitis B immunity? Lancet 2000; 12: 561565.
3.FitzSimons, D, et al. Long-term efficacy of hepatitis B vaccine, booster policy, and impact of hepatitis B virus mutants. Vaccine 2005; 23: 41584166.
4.Gabbuti, A, et al. Long-term immunogenicity of hepatitis B vaccination in a cohort of Italian healthy adolescents. Vaccine 2007; 25: 31293132.
5.Hammitt, LL, et al. Hepatitis B immunity in children vaccinated with recombinant hepatitis B vaccine beginning at birth: A follow-up study at 15 years. Vaccine 2007; 25: 69586964.
6.Lin, YC, et al. Long-term immunogenicity and efficacy of universal hepatitis B virus vaccination in Taiwan. Journal of Infectious Diseases 2003; 187: 134138.
7.Watson, B, et al. Persistence of immunologic memory for 13 years in recipients of a recombinant hepatitis B vaccine. Vaccine 2001; 19: 31643168.
8.Zanetti, A, et al. Long-term immunogenicity of hepatitis B vaccination and policy for booster: an Italian multicentre study. Lancet 2005; 366: 13791384.
9.Shaw, FE, et al. Effect of anatomic injection site, age and smoking on the immune response to hepatitis B vaccination. Vaccine 1989; 7: 425430.
10.Bryan, JP, et al. Low-dose intradermal and intramuscular vaccination against hepatitis B. Clinical Infectious Diseases 1992; 14: 697707.
11.Weber, DJ, et al. Obesity as a predictor of poor antibody response to hepatitis B plasma. Journal of the American Medical Association 1985; 254: 31873189.
12.Zuckerman, JN. Nonresponse to hepatitis B vaccines and the kinetics of Anti-HBs production. Journal of Medical Virology 1996; 50: 283288.
13.Dentinger, C, et al. Persistence of antibody to hepatitis B and protection from disease among Alaska natives immunized at birth. Pediatric Infectious Disease Journal 2005; 24: 786792.
14.Koff, RS. Immunogenicity of hepatitis B vaccines: implications of immune memory. Vaccine 2002; 20: 36953701.
15.Wang, R, et al. Long-term persistence of T cell memory to HBsAg after hepatitis B vaccination. World Journal of Gastroenterology 2004; 10: 260263.
16.Bauer, T, Jilg, W. Hepatitis B surface antigen-specific T and B cell memory in individuals who had lost protective antibodies after hepatitis B vaccination. Vaccine 2006; 24: 572577.
17.Banatvala, JE, Van Damme, P. Hepatitis B vaccine – do we need boosters? Journal of Viral Hepatitis 2003; 10: 16.
18.Ständige Impfkommission am Robert Koch-Institut. Recommendations of the German Standing Vaccination Committee (STIKO) at the Robert Koch Institute (as of July 2007) [in German]. Epidemiologisches Bulletin 2007; 30: 267286.
19.Poethko-Müller, C, Kuhnert, R, Schlaud, M. Vaccination coverage and predictors for vaccination level. Results of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS). Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2007; 50: 851862.
20.Kalies, H, et al. Immunisation status of children in Germany: temporal trends and regional differences. European Journal of Pediatrics 2006; 165: 3036.
21.European Medicines Agency. Questions and answers on the suspension of Hexavac, 2005, London, United Kingdom (http://www.ema.europa.eu/humandocs/PDFs/EPAR/Hexavac/30488805en.pdf). Accessed 26 June 2009.
22.European Medicines Agency. Scientific conclusions and grounds for the suspension of the marketing authorisation of Hexavac presented by the EMEA, 2005 (http://www.emea.europa.eu/humandocs/PDFs/EPAR/Hexavac/Hexavac-H-298-Z-28-en.pdf). Accessed 26 June 2009.
23.Kilpi, T, et al. Immunogenicity and reactogenicity of two diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccines administered at 3, 5 and 11–12 months of age. Human Vaccines 2009; 5: 1825.
24.Mallet, E, et al. Immunogenicity and safety of a new liquid hexavalent combined vaccine compared with separate administration of reference licensed vaccines in infants. Pediatric Infectious Disease Journal 2000; 19: 11191127.
25.Mallet, E, et al. A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B and hepatitis B: review of immunogenicity and safety. Vaccine 2004; 22: 13431357.
26.Tichmann, I, et al. Persistence of antibodies in children primed with two different hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccines and evaluation of booster vaccination. Human Vaccines 2006; 2: 249254.
27.Tichmann, I, et al. Comparison of the immunogenicity and reactogenicity of two commercially available hexavalent vaccines administered as a primary vaccination course at 2, 4 and 6 months of age. Vaccine 2005; 23: 32723279.
28.Kurth, B-M, et al. The challenge of comprehensively mapping children's health in a nation-wide health survey: design of the German KiGGS Study. BMC Public Health 2008; 8: 196.
29.Hölling, H, et al. The German Health Interview and Examination Survey for Children and Adolescents (KiGGS): study management and conduct of fieldwork [in German]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2007; 50: 557566.
30.Thierfelder, W, et al. Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS). Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2007; 50: 757770.
31.Jilg, W, Schmidt, M, Deinhardt, F. Persistence of specific antibodies after hepatitis B vaccination. Journal of Hepatology 1988; 6: 201207.
32.van der Sande, MA, et al. Long-term protection against carriage of hepatitis B virus after infant vaccination. Journal of Infectious Diseases 2006; 193: 15281535.
33.McMahon, BJ, et al. Antibody levels and protection after hepatitis B vaccination: results of a 15-year follow-up. Annals of Internal Medicine 2005; 142: 333341.
34.Faustini, A, et al. Persistence of anti-HBs 5 years after the introduction of routine infant and adolescent vaccination in Italy. Vaccine 2001; 19: 28122818.
35.Giambi, C, et al. A cohort study to evaluate persistence of hepatitis B immunogenicity after administration of hexavalent vaccines. BMC Infectious Diseases 2008; 8: 100.
36.Heininger, U, et al. Booster immunization with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate combination vaccine in the second year of life: safety, immunogenicity and persistence of antibody responses. Vaccine 2007; 25: 10551063.
37.Kesler, K, et al. Immune responses of prematurely born infants to hepatitis B vaccination: results through three years of age. Paediatric Infectious Disease Journal 1998; 17: 116119.
38.Losonsky, GA, et al. Hepatitis B vaccination of premature infants: A reassessment of current recommendations for delayed immunization. Pediatrics 1999; 103: e14.
39.Lau, YL, et al. Response of preterm infants to hepatitis B vaccine. Journal of Pediatrics 1992; 121: 962965.
40.Olivier, C, et al. Immunogenicity, reactogenicity, and safety of a seven-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a fully liquid DTPa-IPV-HBV-Hib combination vaccine in healthy infants. Vaccine 2008; 26: 31423152.
41.Tichmann-Schumann, I, et al. Immunogenicity and reactogenicity of four doses of diphtheria-tetanus three-component acellular pertussis-hepatitis B-inactivated polio virus Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate vaccine. Pediatric Infectious Disease Journal 2005; 24: 7077.
42.Da Villa, G, et al. Impact of hepatitis B vaccination in a highly endemic area of south Italy and long-term duration of anti-HBs antibody in two cohorts of vaccinated individuals. Vaccine 2007; 25: 31333136.
43.Bialek, SR, et al. Persistence of protection against hepatitis B virus infection among adolescents vaccinated with recombinant hepatitis B vaccine beginning at birth: a 15-year follow-up study. Pediatric Infectious Disease Journal 2008; 27: 881885.
44.Whittle, H, et al. Observational study of vaccine efficacy 14 years after trial of hepatitis B vaccination in Gambian children. British Medical Journal 2002; 14: 569573.
45.Samandari, T, et al. Differences in response to a hepatitis B vaccine booster dose among Alaskan children and adolescents vaccinated during infancy. Pediatrics 2007; 120: e373e381.
46.Walter, J, et al. Hepatitis B and C risk factors in Germany – results of the national surveillance [in German]. Gesundheitswesen 2005; 67: 441447.
47.Swissmedic. Notification to health experts, 20 September 2005: Swissmedic suspends the license of the Hexavac vaccine [in German]. Swissmedic Journal 2005; 9: 678679.
48.WHO. International Classification of Diseases (ICD), 2007. World Health Organization (http://apps.who.int/classifications/apps/icd/icd10online/). Accessed 30 October 2009.

Keywords

Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003–2006

  • P. JORGENSEN (a1) (a2), C. POETHKO-MÜLLER (a3), W. HELLENBRAND (a1), W. JILG (a4), W. THIERFELDER (a3), C. MEYER (a1), M. AN DER HEIDEN (a1), M. SCHLAUD (a3) and D. RADUN (a1)...

Metrics

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed