Safety and Immunogenicity of Standard and Double Doses of Hepatitis B Vaccine in Children after Liver Transplantation: An Open-Label, Randomised Controlled Trial
Palittiya Sintusek,
Supranee Buranapraditkun,
Piyaporn Wanawongsawad,
Nawarat Posuwan,
Pattarawat Thantiworasit,
Nasamon Wanlapakorn,
Jettanong Klaewsongkram,
Narissara Suratannon,
Nataruks Chaijitraruch,
Voranush Chongsrisawat,
Yong Poovorawan
Affiliations
Palittiya Sintusek
Division of Gastroenterology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
Supranee Buranapraditkun
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
Piyaporn Wanawongsawad
Excellence Center for Organ Transplantation, King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand
Nawarat Posuwan
Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
Pattarawat Thantiworasit
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
Nasamon Wanlapakorn
Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
Jettanong Klaewsongkram
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
Narissara Suratannon
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
Nataruks Chaijitraruch
Division of Gastroenterology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
Voranush Chongsrisawat
Division of Gastroenterology, Department of Pediatrics, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
Yong Poovorawan
Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
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.
