mRNA SARS-CoV-2 疫苗在肺移植受者中的疗效和安全性。
Efficacy and safety of mRNA SARS-CoV-2 vaccines in lung transplant recipients.
机构信息
Department of Thoracic Surgery, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Miyagi, Japan; Division of Organ Transplantation, Tohoku University Hospital, Sendai, Miyagi, Japan.
Division of Organ Transplantation, Tohoku University Hospital, Sendai, Miyagi, Japan.
出版信息
J Infect Chemother. 2022 Aug;28(8):1153-1158. doi: 10.1016/j.jiac.2022.04.019. Epub 2022 May 17.
BACKGROUND
To date, reports addressing the antibody response following mRNA SARS-CoV-2 vaccination in lung transplant (LTX) recipients are limited. Thus, the aim of this clinical study was to investigate the efficacy and safety of the vaccines in LTX recipients compared to controls.
METHODS
An open-label, nonrandomized prospective study was conducted at Tohoku University Hospital. LTX recipients and controls who received either the BNT162b2 vaccine or the mRNA-1273 vaccine were recruited, and SARS-CoV-2 IgG was measured before and after vaccination. The adverse events were reviewed. Predictors of negative serology after vaccination were evaluated with logistic regression.
RESULTS
Forty-one LTX recipients and 24 controls were analyzed. Although all controls had a positive antibody response to a SARS-CoV-2 mRNA vaccine, antibody response was found in 24.4% of LTX recipients (p < .0001). The amount of SARS-CoV-2 IgG following the 2nd dose significantly climbed to 6557 AU/mL in controls, whereas the increase in IgG in LTX recipients was 8.3 AU/mL (p < .0001). Fewer LTX recipients developed systemic fever than controls (p < .0001) despite equivalent overall adverse event percentages in both groups. A higher plasma concentration of mycophenolate was a significant predictor of negative serology (p = .032).
CONCLUSIONS
An impaired antibody response to mRNA vaccines was significantly found in LTX recipients compared to controls and was associated with the plasma concentration of mycophenolate. While repeating mRNA vaccination may be one of the strategies to improve antibody response given the safety of the vaccines, emerging data on humoral immune responses based on immunosuppression regimens in LTX recipients should be studied (jRCT1021210009).
背景
迄今为止,关于肺移植(LTX)受者接种 mRNA SARS-CoV-2 疫苗后的抗体反应的报告有限。因此,本临床研究的目的是比较 LTX 受者与对照组疫苗的疗效和安全性。
方法
在东北大学医院进行了一项开放标签、非随机前瞻性研究。招募了接受 BNT162b2 疫苗或 mRNA-1273 疫苗的 LTX 受者和对照组,并在接种前后测量 SARS-CoV-2 IgG。审查了不良事件。使用逻辑回归评估接种后血清学阴性的预测因素。
结果
分析了 41 名 LTX 受者和 24 名对照组。尽管所有对照组对 SARS-CoV-2 mRNA 疫苗均有阳性抗体反应,但 LTX 受者中发现有 24.4%(p<0.0001)抗体反应。对照组第 2 剂后 SARS-CoV-2 IgG 量明显增加至 6557 AU/mL,而 LTX 受者 IgG 增加 8.3 AU/mL(p<0.0001)。与对照组相比,LTX 受者发生全身性发热的人数较少(p<0.0001),尽管两组的总体不良事件百分比相当。麦考酚酸血浆浓度较高是血清学阴性的显著预测因素(p=0.032)。
结论
与对照组相比,LTX 受者对 mRNA 疫苗的抗体反应明显受损,与麦考酚酸的血浆浓度有关。鉴于疫苗的安全性,重复接种 mRNA 疫苗可能是提高抗体反应的策略之一,但应研究 LTX 受者基于免疫抑制方案的体液免疫反应的新数据(jRCT1021210009)。