Alessandro Zanetti1, Maria Giuseppina Desole2, Luisa Romanò3, Antonio d'Alessandro4, Michele Conversano5, Giuseppe Ferrera6, Maria Grazia Panico7, Alberto Tomasi8, Giorgio Zoppi9, Massimo Zuliani10, Stéphane Thomas11, Benoît Soubeyrand12, Cécile Eymin13, Stephen Lockhart14. 1. Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, 20133 Milano, Italy. Electronic address: alessandro.zanetti@unimi.it. 2. ASL di Sassari, Servizio di Igiene Pubblica, Via Rizzeddu, 21/b, 07100 Sassari, Italy. Electronic address: madesole@aslsassari.it. 3. Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, 20133 Milano, Italy. Electronic address: luisa.romano@unimi.it. 4. ASL Salerno, Dipartimento di Prevenzione Servizio Epidemiologia e Prevenzione, Via Bruno Grimaldi 60, 84014 Nocera Inferiore, Salerno, Italy. Electronic address: dalean1@alice.it. 5. ASL 1 Taranto, Servizio di Igiene Pubblica, Ospedale Civile Pagliari, Viale Magna Grecia, 74016 Massafra, Taranto, Italy. Electronic address: dip.conversano@libero.it. 6. ASP 7 Ragusa, Servizio di Epidemiologia e Prevenzione, Via Aldo Licitra, 11, 97100 Ragusa, Italy. Electronic address: g.ferrera@asp.rg.it. 7. Servizio di Epidemiologia ASL Salerno, Via Settimio Mobilio, 52, 84100 Salerno, Italy. Electronic address: g.panico@aslsalerno.it. 8. ASL 2 Lucca, U.O. Igiene e Sanità Pubblica, Dipartimento della Prevenzione, Piazza Aldo Moro, 5, 55012 Capannori, Lucca, Italy. Electronic address: alberto.tomasi@uslnordovest.toscana.it. 9. ASL n. 4 Chiavarese, Dipartimento di Prevenzione, Struttura Complessa Igiene e Sanità Pubblica, Corso Dante, 16043 Chiavari, Genova, Italy. Electronic address: gzoppi@asl4.liguria.it. 10. ASS n. 5 "Bassa Friulana", Dipartimento di Prevenzione Servizio di Igiene e Sanità Pubblica c/o Ospedale di Latisana, Via Sabbionera 45, 33053 Latisana, Udine, Italy. Electronic address: massimo.zuliani@aas3.sanita.fvg.it. 11. Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: stephane.thomas10@free.fr. 12. Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: benoitsoubeyrand@gmail.com. 13. Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: Cecile.EYMIN@sanofi.com. 14. Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: hurstgrange@btinternet.com.
Abstract
BACKGROUND AND AIMS: The strategy of vaccinating infants to prevent hepatitis B virus infection in adolescence or adulthood requires durable immunity. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children primed with three doses of either Hexavac® or Infanrix hexa® 10years earlier during infancy. METHODS: This open-label, controlled, multicentre study conducted in Italy, enrolled 751 healthy pre-adolescents (aged 11-13years) who were given either Hexavac (n=409) or Infanrix hexa (n=342) at 3, 5 and 11months of life. All participants received a challenge dose of a monovalent hepatitis B vaccine (HBVaxPro® 5µg). The concentrations of antibodies to hepatitis B surface antigen (anti-HBs) were measured before and 1month after the challenge dose. The analysis was descriptive and no formal hypothesis was tested. RESULTS: One month post-challenge, 331 participants in the Hexavac cohort [83.6%, 95% CI: 79.6; 87.1] and 324 in the Infanrix hexa cohort [96.4%, 95% CI: 93.8; 98.1] had anti-HBs concentrations ≥10mIU/mL. Before the challenge dose, an anti-HBs concentration of ≥10mIU/mL was found in 94 children in the Hexavac cohort [23.9%, 95% CI: 19.7; 28.4] and in 232 children in the Infanrix hexa cohort [69%, 95% CI: 63.8; 74.0]. Among children with a pre-challenge anti-HBs concentration of <10mIU/mL, 236 [78.7%, 95% CI: 73.6; 83.2] in the Hexavac cohort and 92 [88.5%, 95% CI: 80.7; 93.9] in the Infanrix hexa cohort achieved protective anti-HBs antibody concentrations. No evidence of active hepatitis B disease was observed in either group, and the HBVaxPro challenge dose was well tolerated. CONCLUSIONS: These data confirm that immune memory persists in a high percentage of children (>80%) at least 10years after a two-dose primary and booster vaccination schedule with a hexavalent vaccine (Hexavac or Infanrix hexa). TRIAL REGISTRATION: EudraCT Number: 2013-001602-28; clinicaltrials.gov: NCT02012998.
RCT Entities:
BACKGROUND AND AIMS: The strategy of vaccinating infants to prevent hepatitis B virus infection in adolescence or adulthood requires durable immunity. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children primed with three doses of either Hexavac® or Infanrix hexa® 10years earlier during infancy. METHODS: This open-label, controlled, multicentre study conducted in Italy, enrolled 751 healthy pre-adolescents (aged 11-13years) who were given either Hexavac (n=409) or Infanrix hexa (n=342) at 3, 5 and 11months of life. All participants received a challenge dose of a monovalent hepatitis B vaccine (HBVaxPro® 5µg). The concentrations of antibodies to hepatitis B surface antigen (anti-HBs) were measured before and 1month after the challenge dose. The analysis was descriptive and no formal hypothesis was tested. RESULTS: One month post-challenge, 331 participants in the Hexavac cohort [83.6%, 95% CI: 79.6; 87.1] and 324 in the Infanrix hexa cohort [96.4%, 95% CI: 93.8; 98.1] had anti-HBs concentrations ≥10mIU/mL. Before the challenge dose, an anti-HBs concentration of ≥10mIU/mL was found in 94 children in the Hexavac cohort [23.9%, 95% CI: 19.7; 28.4] and in 232 children in the Infanrix hexa cohort [69%, 95% CI: 63.8; 74.0]. Among children with a pre-challenge anti-HBs concentration of <10mIU/mL, 236 [78.7%, 95% CI: 73.6; 83.2] in the Hexavac cohort and 92 [88.5%, 95% CI: 80.7; 93.9] in the Infanrix hexa cohort achieved protective anti-HBs antibody concentrations. No evidence of active hepatitis B disease was observed in either group, and the HBVaxPro challenge dose was well tolerated. CONCLUSIONS: These data confirm that immune memory persists in a high percentage of children (>80%) at least 10years after a two-dose primary and booster vaccination schedule with a hexavalent vaccine (Hexavac or Infanrix hexa). TRIAL REGISTRATION: EudraCT Number: 2013-001602-28; clinicaltrials.gov: NCT02012998.
Authors: Iman I Salama; Samia M Sami; Safaa M Elserougy; Hanaa M Emam; Somaia I Salama; Hazem M Elhariri; Samia A Hemeda; Amal I Hassanain; Aida M Abdel Mohsen; Walaa A Fouad; Lobna A El Etreby; Zeinab N Said Journal: Oman Med J Date: 2020-09-30