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,Piyaporn Wanawongsawad,Pattarawat Thantiworasit,Nataruks Chaijitraruch,Supranee Buranapraditkun,Narissara Suratannon,Nawarat Posuwan,Voranush Chongsrisawat,Yong Poovorawan,Jettanong Klaewsongkram,Nasamon Wanlapakorn

doi:10.3390/vaccines10010092

Palittiya Sintusek, Piyaporn Wanawongsawad + Show 9 more

Open Access

https://doi.org/10.3390/vaccines10010092

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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.

Highlights

Hepatitis B (HepB) infection poses a major public health challenge worldwide [1].Approximately 12.4% of people infected with hepatitis B (HepB) have chronic infection, and 15–20% of chronic carriers die from cirrhosis or hepatocellular carcinoma [2]
One participant in the standard threedose (SD) group could not visit the hospital at the proper time, and one participant in the double three-dose (DD) group was diagnosed with post-transplant lymphoproliferative disorders that progressed to B-cell lymphoma
61 participants received the three-dose vaccine regimen according to the study protocol (31 and 30 children in the SD and DD groups, respectively) (Figure 1)

Summary

Introduction

Hepatitis B (HepB) infection poses a major public health challenge worldwide [1].Approximately 12.4% of people infected with HepB have chronic infection, and 15–20% of chronic carriers die from cirrhosis or hepatocellular carcinoma [2]. Hepatitis B (HepB) infection poses a major public health challenge worldwide [1]. The level of antibodies against the HepB surface antigen (anti-HBs) declines to less than the seroprotective level (

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