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Article

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

by
Palittiya Sintusek
1,2,
Supranee Buranapraditkun
2,3,4,
Piyaporn Wanawongsawad
5,
Nawarat Posuwan
6,
Pattarawat Thantiworasit
3,
Nasamon Wanlapakorn
6,
Jettanong Klaewsongkram
3,
Narissara Suratannon
7,
Nataruks Chaijitraruch
1,
Voranush Chongsrisawat
1 and
Yong Poovorawan
6,*
1
Division of Gastroenterology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
2
Thai Pediatric Gastroenterology, Hepatology and Immunology (TPGHAI) Research Unit, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkon University, The Thai Red Cross Society, Bangkok 10330, Thailand
3
Division of Allergy and Clinical Immunology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Thai Red Cross Society, Bangkok 10330, Thailand
4
Center of Excellence in Vaccine Research and Development (Chula Vaccine Research Center-Chula VRC), Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
5
Excellence Center for Organ Transplantation, King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand
6
Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
7
Pediatric Allergy and Clinical Immunology Research Unit, Division of Allergy and Immunolgy, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, The Thai Red Cross Society, Bangkok 10330, Thailand
*
Author to whom correspondence should be addressed.
Vaccines 2022, 10(1), 92; https://doi.org/10.3390/vaccines10010092
Submission received: 11 December 2021 / Revised: 4 January 2022 / Accepted: 5 January 2022 / Published: 8 January 2022
(This article belongs to the Special Issue Hepatitis and Vaccines)
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Abstract

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.
Keywords: children; hepatitis B virus; de novo hepatitis B; liver transplantation; vaccine; immunization children; hepatitis B virus; de novo hepatitis B; liver transplantation; vaccine; immunization

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MDPI and ACS Style

Sintusek, P.; Buranapraditkun, S.; Wanawongsawad, P.; Posuwan, N.; Thantiworasit, P.; Wanlapakorn, N.; Klaewsongkram, J.; Suratannon, N.; Chaijitraruch, N.; Chongsrisawat, V.; et al. Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial. Vaccines 2022, 10, 92. https://doi.org/10.3390/vaccines10010092

AMA Style

Sintusek P, Buranapraditkun S, Wanawongsawad P, Posuwan N, Thantiworasit P, Wanlapakorn N, Klaewsongkram J, Suratannon N, Chaijitraruch N, Chongsrisawat V, et al. Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial. Vaccines. 2022; 10(1):92. https://doi.org/10.3390/vaccines10010092

Chicago/Turabian Style

Sintusek, Palittiya, Supranee Buranapraditkun, Piyaporn Wanawongsawad, Nawarat Posuwan, Pattarawat Thantiworasit, Nasamon Wanlapakorn, Jettanong Klaewsongkram, Narissara Suratannon, Nataruks Chaijitraruch, Voranush Chongsrisawat, and et al. 2022. "Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial" Vaccines 10, no. 1: 92. https://doi.org/10.3390/vaccines10010092

APA Style

Sintusek, P., Buranapraditkun, S., Wanawongsawad, P., Posuwan, N., Thantiworasit, P., Wanlapakorn, N., Klaewsongkram, J., Suratannon, N., Chaijitraruch, N., Chongsrisawat, V., & Poovorawan, Y. (2022). Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial. Vaccines, 10(1), 92. https://doi.org/10.3390/vaccines10010092

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