دورية أكاديمية
أعرض في EDS

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.

التفاصيل البيبلوغرافية
العنوان: 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.
المؤلفون: Zanetti A; Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, 20133 Milano, Italy. Electronic address: alessandro.zanetti@unimi.it., Desole MG; ASL di Sassari, Servizio di Igiene Pubblica, Via Rizzeddu, 21/b, 07100 Sassari, Italy. Electronic address: madesole@aslsassari.it., Romanò L; Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, 20133 Milano, Italy. Electronic address: luisa.romano@unimi.it., d'Alessandro A; ASL Salerno, Dipartimento di Prevenzione Servizio Epidemiologia e Prevenzione, Via Bruno Grimaldi 60, 84014 Nocera Inferiore, Salerno, Italy. Electronic address: dalean1@alice.it., Conversano M; ASL 1 Taranto, Servizio di Igiene Pubblica, Ospedale Civile Pagliari, Viale Magna Grecia, 74016 Massafra, Taranto, Italy. Electronic address: dip.conversano@libero.it., Ferrera G; ASP 7 Ragusa, Servizio di Epidemiologia e Prevenzione, Via Aldo Licitra, 11, 97100 Ragusa, Italy. Electronic address: g.ferrera@asp.rg.it., Panico MG; Servizio di Epidemiologia ASL Salerno, Via Settimio Mobilio, 52, 84100 Salerno, Italy. Electronic address: g.panico@aslsalerno.it., Tomasi A; 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., Zoppi G; 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., Zuliani M; 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., Thomas S; Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: stephane.thomas10@free.fr., Soubeyrand B; Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: benoitsoubeyrand@gmail.com., Eymin C; Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: Cecile.EYMIN@sanofi.com., Lockhart S; Sanofi Pasteur MSD, 162 avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France. Electronic address: hurstgrange@btinternet.com.
المصدر: Vaccine [Vaccine] 2017 Jul 13; Vol. 35 (32), pp. 4034-4040. Date of Electronic Publication: 2017 Jun 16.
نوع المنشور: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
مواضيع طبية MeSH: Immunization Schedule* , Immunologic Memory*, Diphtheria-Tetanus-Pertussis Vaccine/*adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/*immunology , Haemophilus Vaccines/*adverse effects , Haemophilus Vaccines/*immunology , Hepatitis B Surface Antigens/*blood , Hepatitis B Vaccines/*adverse effects , Hepatitis B Vaccines/*immunology , Poliovirus Vaccine, Inactivated/*adverse effects , Poliovirus Vaccine, Inactivated/*immunology, Adolescent ; Child ; Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage ; Female ; Haemophilus Vaccines/administration & dosage ; Healthy Volunteers ; Hepatitis B Vaccines/administration & dosage ; Humans ; Infant ; Italy ; Male ; Poliovirus Vaccine, Inactivated/administration & dosage ; Time Factors ; Vaccines, Combined/administration & dosage ; Vaccines, Combined/adverse effects ; Vaccines, Combined/immunology
مستخلص: 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.
(Copyright © 2017 Elsevier Ltd. All rights reserved.)
فهرسة مساهمة: Keywords: Challenge dose; Hepatitis B; Hexavalent vaccine; Immune memory; Vaccinated children
سلسلة جزيئية: EudraCT 2013-001602-28
ClinicalTrials.gov NCT02012998
المشرفين على المادة: 0 (Diphtheria-Tetanus-Pertussis Vaccine)
0 (Haemophilus Vaccines)
0 (Hepatitis B Surface Antigens)
0 (Hepatitis B Vaccines)
0 (Hexavac)
0 (Poliovirus Vaccine, Inactivated)
0 (Vaccines, Combined)
0 (diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine)
تواريخ الأحداث: Date Created: 20170619 Date Completed: 20180312 Latest Revision: 20180402
رمز التحديث: 20240829
DOI: 10.1016/j.vaccine.2017.05.047
PMID: 28624307
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2017.05.047