Transplant Clinical Pharmacy Section, Organ Transplant Centre of Excellence, King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia.
Kidney & Pancreas Health Centre, Organ Transplant Centre of Excellence, King Faisal Specialist Hospital & Research Centre, Riyadh, Kingdom of Saudi Arabia.
Clin Transplant. 2023 Jun;37(6):e14983. doi: 10.1111/ctr.14983. Epub 2023 Apr 7.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of persons worldwide. Many vaccines have been developed; however, their efficacy in pediatric solid organ transplant recipients is yet to be determined.
This is a prospective observational, non-interventional single-center study on the safety and efficacy of a COVID-19 vaccine (BNT162b2) in pediatric kidney transplant recipients. The primary aim of this study was to evaluate immunogenicity according to SARS-CoV-2-specific neutralizing antibody titer after two vaccine doses. The secondary aims were to investigate the safety of the vaccines, solicited local and systemic adverse reactions, incidence of COVID-19 post-vaccination, and effects on transplant graft function. Baseline investigations were conducted on pediatric renal transplant recipients, and recruited participants were advised to have the Comirnaty® mRNA vaccine according to protocol.
A total of 48 patients (male, n = 31, 64.6%; female, n = 17, 35.4%), median age 14 [12-16] years were included, and all received two doses of the vaccine. The vaccine had a favorable safety and side-effect profile. The S-antibody titer of all patients ranged between .4 and 2,500 U/ml and was > 50 U/ml in 89% of the patients. No difference in the measured antibody immune response was noted between infected and uninfected children. No major side effects were reported.
The vaccine had a favorable safety profile in 12- to 15-year-old kidney transplant recipients, producing a greater measured antibody response than that in older transplant recipients.
严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）感染及其导致的疾病，即 2019 年冠状病毒病（COVID-19），已在全球范围内蔓延至数百万人。目前已开发出多种疫苗，但这些疫苗在儿科实体器官移植受者中的疗效仍有待确定。
这是一项针对儿科肾移植受者 COVID-19 疫苗（BNT162b2）安全性和有效性的前瞻性观察性、非干预性单中心研究。本研究的主要目的是根据 SARS-CoV-2 特异性中和抗体滴度评估两剂疫苗接种后的免疫原性。次要目的是调查疫苗的安全性、疫苗接种后的不良反应、COVID-19 的发生率以及对移植移植物功能的影响。在儿科肾移植受者中进行了基线调查，并根据方案建议招募参与者接种 Comirnaty® mRNA 疫苗。
共纳入 48 例患者（男性 31 例，占 64.6%；女性 17 例，占 35.4%），中位年龄 14 岁[12-16]岁，均接受两剂疫苗接种。疫苗具有良好的安全性和副作用特征。所有患者的 S 抗体滴度在.4 至 2,500 U/ml 之间，89%的患者的抗体滴度>50 U/ml。感染和未感染儿童之间的抗体免疫反应无差异。未报告重大副作用。
该疫苗在 12-15 岁的肾移植受者中具有良好的安全性，产生的抗体反应大于年龄较大的移植受者。
