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Vaccine. 2017 Jul 13;35(32):4034-4040. doi: 10.1016/j.vaccine.2017.05.047. Epub 2017 Jun 16.

Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy.

Author information

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.

KEYWORDS:

Challenge dose; Hepatitis B; Hexavalent vaccine; Immune memory; Vaccinated children

PMID:
28624307
DOI:
10.1016/j.vaccine.2017.05.047
[Indexed for MEDLINE]

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