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Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial

A high prevalence of hepatitis B (HepB) antibody loss after liver transplantation (LT) and de novo HepB infection (DNH) was documented, hence revaccination to prevent DNH is crucial. This study aimed to compare the safety and immunogenicity of two HepB vaccine regimens in liver-transplanted children...

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Autores principales: Sintusek, Palittiya, Buranapraditkun, Supranee, Wanawongsawad, Piyaporn, Posuwan, Nawarat, Thantiworasit, Pattarawat, Wanlapakorn, Nasamon, Klaewsongkram, Jettanong, Suratannon, Narissara, Chaijitraruch, Nataruks, Chongsrisawat, Voranush, Poovorawan, Yong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8778427/
https://www.ncbi.nlm.nih.gov/pubmed/35062752
http://dx.doi.org/10.3390/vaccines10010092
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author Sintusek, Palittiya
Buranapraditkun, Supranee
Wanawongsawad, Piyaporn
Posuwan, Nawarat
Thantiworasit, Pattarawat
Wanlapakorn, Nasamon
Klaewsongkram, Jettanong
Suratannon, Narissara
Chaijitraruch, Nataruks
Chongsrisawat, Voranush
Poovorawan, Yong
author_facet Sintusek, Palittiya
Buranapraditkun, Supranee
Wanawongsawad, Piyaporn
Posuwan, Nawarat
Thantiworasit, Pattarawat
Wanlapakorn, Nasamon
Klaewsongkram, Jettanong
Suratannon, Narissara
Chaijitraruch, Nataruks
Chongsrisawat, Voranush
Poovorawan, Yong
author_sort Sintusek, Palittiya
collection PubMed
description A high prevalence of hepatitis B (HepB) antibody loss after liver transplantation (LT) and de novo HepB infection (DNH) was documented, hence revaccination to prevent DNH is crucial. This study aimed to compare the safety and immunogenicity of two HepB vaccine regimens in liver-transplanted children. Liver-transplanted children who were previously immunised but showed HepB surface antibodies (anti-HBs) ≤ 100 mIU/mL were randomised to receive a standard three-dose (SD) and double three-dose (DD) vaccine intramuscularly in months 0–1–6. Anti-HBs and T-cell-specific response to the HepB antigen were assessed. A total of 61 children (54.1% male, aged 1.32 ± 1.02 years) completed the study without any serious adverse reaction. The seroprotective rate was 69.6% vs. 60% (p = 0.368) and 91.3% vs. 85% (p = 0.431) in SD and DD after the first and third 3-dose vaccinations, respectively. The geometric mean titre (95% confidence interval) of anti-HBs in SD and DD were 443.33 (200.75–979.07) vs. 446.17 (155.58–1279.50) mIU/mL, respectively, at completion. Numbers of interferon-γ-secreting cells were higher in hyporesponders/responders than in nonresponders (p = 0.003). The significant factors for the immunologic response to HepB vaccination were anti-HB levels prevaccination, tacrolimus trough levels, and time from LT to revaccination. SD and DD had comparative immunogenicity and were safe for liver-transplanted children who were previously immunised.
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spelling pubmed-87784272022-01-22 Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial Sintusek, Palittiya Buranapraditkun, Supranee Wanawongsawad, Piyaporn Posuwan, Nawarat Thantiworasit, Pattarawat Wanlapakorn, Nasamon Klaewsongkram, Jettanong Suratannon, Narissara Chaijitraruch, Nataruks Chongsrisawat, Voranush Poovorawan, Yong Vaccines (Basel) Article A high prevalence of hepatitis B (HepB) antibody loss after liver transplantation (LT) and de novo HepB infection (DNH) was documented, hence revaccination to prevent DNH is crucial. This study aimed to compare the safety and immunogenicity of two HepB vaccine regimens in liver-transplanted children. Liver-transplanted children who were previously immunised but showed HepB surface antibodies (anti-HBs) ≤ 100 mIU/mL were randomised to receive a standard three-dose (SD) and double three-dose (DD) vaccine intramuscularly in months 0–1–6. Anti-HBs and T-cell-specific response to the HepB antigen were assessed. A total of 61 children (54.1% male, aged 1.32 ± 1.02 years) completed the study without any serious adverse reaction. The seroprotective rate was 69.6% vs. 60% (p = 0.368) and 91.3% vs. 85% (p = 0.431) in SD and DD after the first and third 3-dose vaccinations, respectively. The geometric mean titre (95% confidence interval) of anti-HBs in SD and DD were 443.33 (200.75–979.07) vs. 446.17 (155.58–1279.50) mIU/mL, respectively, at completion. Numbers of interferon-γ-secreting cells were higher in hyporesponders/responders than in nonresponders (p = 0.003). The significant factors for the immunologic response to HepB vaccination were anti-HB levels prevaccination, tacrolimus trough levels, and time from LT to revaccination. SD and DD had comparative immunogenicity and were safe for liver-transplanted children who were previously immunised. MDPI 2022-01-08 /pmc/articles/PMC8778427/ /pubmed/35062752 http://dx.doi.org/10.3390/vaccines10010092 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sintusek, Palittiya
Buranapraditkun, Supranee
Wanawongsawad, Piyaporn
Posuwan, Nawarat
Thantiworasit, Pattarawat
Wanlapakorn, Nasamon
Klaewsongkram, Jettanong
Suratannon, Narissara
Chaijitraruch, Nataruks
Chongsrisawat, Voranush
Poovorawan, Yong
Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial
title Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial
title_full Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial
title_fullStr Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial
title_full_unstemmed Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial
title_short Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial
title_sort safety and immunogenicity of standard and double doses of hepatitis b vaccine in children after liver transplantation: an open-label, randomised controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8778427/
https://www.ncbi.nlm.nih.gov/pubmed/35062752
http://dx.doi.org/10.3390/vaccines10010092
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