Chevallier Patrice, Coste-Burel Marianne, Le Bourgeois Amandine, Peterlin Pierre, Garnier Alice, Béné Marie C, Imbert Berthe-Marie, Drumel Thomas, Le Gouill Steven, Moreau Philippe, Mahe Beatrice, Dubruille Viviane, Blin Nicolas, Lok Anne, Touzeau Cyrille, Gastinne Thomas, Jullien Maxime, Vanthygem Sophie, Guillaume Thierry
Department of Hematology Nantes University Hospital Nantes France.
INSERM UMR1232 CRCINA IRS-UN University of Nantes Nantes France.
EJHaem. 2021 Jun 1;2(3):520-524. doi: 10.1002/jha2.242. eCollection 2021 Aug.
This was a monocentric prospective study testing the efficacy and safety of a first injection of BNT162b2 (Pfizer-BioNTech) in 112 Allo-HSCT patients. Antibody response to SARS-CoV-2 spike protein receptor-binding domain was tested at the time of the second injection (Roche Elecsys). The study also included a non-randomized control arm of 26 healthy controls. This study shows that a first dose of SARS-CoV-2 messenger RNA vaccine is safe and provides a 55% rate of seroconversion in allotransplanted patients compared to 100% for the controls ( < 0.001). Factors influencing the absence of response in patients were recent transplantation (<2 years), lymphopenia (<1 × 10/L) and immunosuppressive treatment or chemotherapy at the time of vaccination.
这是一项单中心前瞻性研究,旨在测试首次注射BNT162b2(辉瑞- BioNTech)对112例异基因造血干细胞移植(Allo-HSCT)患者的疗效和安全性。在第二次注射时(罗氏诊断公司的Elecsys检测法)检测了对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)刺突蛋白受体结合域的抗体反应。该研究还包括一个由26名健康对照组成的非随机对照组。这项研究表明,首剂SARS-CoV-2信使核糖核酸疫苗是安全的,在接受同种异体移植的患者中血清转化率为55%,而对照组为100%(P<0.001)。影响患者无反应的因素包括近期移植(<2年)、淋巴细胞减少(<1×10⁹/L)以及接种疫苗时的免疫抑制治疗或化疗。