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

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.

Safety and Efficacy of a Third Dose of the BNT162b2 Vaccine in Liver-Transplanted and Healthy Adolescents

“…The immune response to vaccination in LT children might be more rigorous than in LT adults because of many factors, such as their younger age (20) and less comorbidity (21). Previous research on hepatitis B revaccination in LT children demonstrated a good response and slow-waning immunity, which differed from adult studies (27) and could explain why the immune response in LT children and adults could not be comparable. Hence, it is important to consider a specific study in the child population rather than generalizing the vaccination regimen based on adult data.…”

Hepatitis B antibody levels after different doses of hepatitis B vaccination: a retrospective study based on hospitalized children

“…The last category included studies aiming at different immunization procedures. Jilg et al [14], Goldfarb et al [26], Sintusek et al [27], and Greenberg et al [28] studied the difference in the HBsAb positivity rate according to varying vaccination times (0, 1, 6; 0, 1, 12; 2, 4, 6 months) and varying dosages (5, 10, and 20 μg immunization). Taking the above factors into account, it could be reasonably explained that the positivity rate of HBsAb in the current study was higher than that in previous studies.…”