Challenge with a hepatitis B vaccine in two cohorts of 4-7-year-old children primed with hexavalent vaccines: An open-label, randomised trial in Italy

Vaccine

Volumn 30, Issue 39, 2012, Pages 5770-5775

  Zanetti, Alessandro ^a   Parlato, Antonino ^b   Romanò, Luisa ^a   Desole, Maria Giuseppina ^c   Ferrera, Giuseppe ^d   Giurdanella, Filippo ^e   Zuliani, Massimo ^f   Richard, Patrick ^g   Thomas, Stéphane ^g   Fiquet, Anne ^g,h  

^a UNIVERSITY OF MILAN   (Italy)

^b ASL Napoli 2   (Italy)

^c ASL n 1 Servizio di Igiene Pubblica   (Italy)

^d Servizio di Epidemiologia   (Italy)

^e MAGGIORE HOSPITAL   (Italy)

^f Servizio Igiene e Sanità Pubblica ^*  (Italy)

^g SANOFI PASTEUR   (France)

^h PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Children; Hepatitis B challenge vaccine dose; Hexavac; Immune memory; Infanrix Hexa; Randomised clinical trial

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; HEPATITIS B SURFACE ANTIBODY; HEPATITIS B VACCINE; RECOMBINANT HEPATITIS B VACCINE;

APPLICATION SITE IRRITATION; ARTICLE; CHILD; COHORT ANALYSIS; CONFIDENCE INTERVAL; CONTROLLED STUDY; ERYTHEMA; HUMAN; HUMAN EXPERIMENT; IMMUNIZATION; IMMUNOLOGICAL MEMORY; INFANCY; INJECTION SITE BLEEDING; ITALY; NERVE FIBER DEGENERATION; NORMAL HUMAN; OPEN STUDY; PAIN; POST HOC ANALYSIS; PRESCHOOL CHILD; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SWELLING; VACCINATION;

CHILD; CHILD, PRESCHOOL; DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS VACCINES; DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; HAEMOPHILUS VACCINES; HEPATITIS B ANTIBODIES; HEPATITIS B VACCINES; HUMANS; IMMUNOLOGIC MEMORY; ITALY; POLIOVIRUS VACCINE, INACTIVATED;

EID: 84864927846     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.06.078     Document Type: Article

References (22)

1. Capiau C., Poolman J., Hoet B., Bogaerts H., Andre F. Development and clinical testing of multivalent vaccines based on a diphtheria-tetanus-acellular pertussis vaccine: difficulties encountered and lessons learned. Vaccine 2003, 21(19-20):2273-2287.
2. Kalies H., Grote V., Verstraeten T., Hessel L., Schmitt H.J., von Kries R. The use of combination vaccines has improved timeliness of vaccination in children. Pediatr Infect Dis J 2006, 25:507-512.
3. European Medicines Agency. European Medicines Agency recommends suspension of Hexavac. 20 September 2005. Available at: [accessed 17.5.11]. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/12/WC500017695.pdf.
4. Grosheide P., Van Damme P. Prevention and control of hepatitis B in the community. Communicable diseases series 1 1996, 1-60. WHO & Viral Hepatitis Prevention Board, Copenhagen and Antwerp. J. Hallauer, M. Kane, E. McCoy, A. Meleus, C. Moure (Eds.).
5. Reinert P., Cinquetti S., Soubeyrand B., Biasio L.R., Meghlaoui G., Thomas S., et al. Challenge with hepatitis B vaccine in children previously vaccinated with a hepatitis B-containing combination vaccine. Adv Ther 2010, 27:28-38. [Erratum in Adv Ther 2010;27:192.].
6. Zanetti A.R., Romanò L., Giambi C., Pavan A., Carnelli V., Baitelli G., et al. Hepatitis B immune memory in children primed with hexavalent vaccines and given monovalent booster vaccines: an open-label, randomised, controlled, multicentre study. Lancet Infect Dis 2010, 10:755-761.
7. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Amended October 2000. Available at: [accessed 5.04.11]. http://www.wma.net/en/30publications/10policies/b3/index.html.
8. European Medicines Agency. ICH topic E6 guideline for good clinical practice. Step 5, consolidated guideline. CPMP/ICH/135/95. Available at: [accessed 05.04.11]. http://www.fnclcc.fr/doc/pdf/lois/BPC-ICHE6.pdf.
9. Jorgensen P., Poethko-Müller C., Hellenbrand W., Jilg W., Thierfelder W., Meyer C., et al. Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003-2006. Epidemiol Infect 2010, 138:1621-1629.
10. Giambi C., Bella A., Barale A., Montù D., Marchisio M., Oddone M., et al. A cohort study to evaluate persistence of hepatitis B immunogenicity after administration of hexavalent vaccines. BMC Infect Dis 2008, 8:100.
11. Zinke M., Kappes R., Kindler K., Paulus-Koschik A., Goering U., Disselhoff J., et al. Immune memory to hepatitis B virus in 4-9-year-old children vaccinated in infancy with four doses of hexavalent DTPa-HBV-IPV/Hib vaccine. Hum Vaccin 2009, 5:592-598.
12. Steiner M., Ramakrishnan G., Gartner B., Van Der Meeren O., Jacquet J.M., Schuster V. Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Infect Dis 2010, 10:9.
13. Zanetti A.R., Mariano A., Romanò L., D'Amelio R., Chironna M., Coppola R.C., et al. Long-term immunogenicity of hepatitis B vaccination and policy for booster: an Italian multicentre study. Lancet 2005, 366:1379-1384.
14. SEIEVA (Sistema Epidemiologico Integrato dell'Epatite Virale Acuta)/ISS (Istituto Superiore di Sanità). Surveillance programme for viral hepatitis B in cohorts of Italian children born from 01 January 2000-31 December 2005; Personal communication.
15. Yuen M.F., Lim W.L., Cheng C.C., Lam S.K., Lai C.L. Twelve-year follow-up of a prospective randomized trial of hepatitis B recombinant DNA yeast vaccine versus plasma-derived vaccine without booster doses in children. Hepatology 1999, 29:924-927.
16. Patel P.R., Armstrong G.L., Samandari T., Talekar S., Yamaguchi K., Kuhnert W.L., et al. Long term effectiveness of hepatitis B vaccine in Palau. Abstract 1035 presented at the 42nd Annual Meeting of the Infectious Diseases Society of America 2004.
17. van der Sande M.A., Waight P., Mendy M., Rayco-Solon P., Hutt P., Fulford T., et al. Long-term protection against carriage of hepatitis B virus after infant vaccination. J Infect Dis 2006, 193:1528-1535.
18. Ni Y.H., Huang L.M., Chang M.H., Yen C.J., Lu C.Y., You S.L., et al. Two decades of universal hepatitis B vaccination in Taiwan: impact and implication for future strategies. Gastroenterology 2007, 132:1287-1293.
19. But D.Y., Lai C.L., Lim W.L., Fung J., Wong D.K., Yuen M.F. Twenty-two years follow-up of a prospective randomized trial of hepatitis B vaccines without booster dose in children: final report. Vaccine 2008, 26:6587-6591.
20. Poorolajal J., Mahmoodi M., Majdzadeh R., Nasseri-Moghaddam S., Haghdoost A., Fotouhi A. Long-term protection provided by hepatitis B vaccine and need for booster dose: a meta-analysis. Vaccine 2010, 28:623-631.
21. World Health Organization Informal consultation on quadrivalent diphtheria-tetanus-pertussis-hepatitis B vaccine. Final report 1992, World Health Organization, Geneva, pp. 1-12.
22. Centers for Disease Control. Recommendations of the immunization practices advisory committee update on hepatitis B prevention. MMWR Morb Mortal Wkly Rep 1987;36:353-66. Available at: [accessed 17.05.2011]. http://www.cdc.gov/mmwr/preview/mmwrhtml/00019181.htm.