Watanabe Marika, Yakushijin Kimikazu, Funakoshi Yohei, Ohji Goh, Hojo Wataru, Sakai Hironori, Saeki Miki, Hirakawa Yuri, Matsumoto Sakuya, Sakai Rina, Nagao Shigeki, Kitao Akihito, Miyata Yoshiharu, Koyama Taiji, Saito Yasuyuki, Kawamoto Shinichiro, Ito Mitsuhiro, Murayama Tohru, Matsuoka Hiroshi, Minami Hironobu
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.
Division of Infectious Disease Therapeutics, Department of Microbiology and Infectious Diseases, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.
Vaccines (Basel). 2022 Jan 21;10(2):158. doi: 10.3390/vaccines10020158.
Patients who have undergone hematopoietic stem cell transplantation (HSCT) for hematological disease experience high mortality when infected by coronavirus disease 2019 (COVID-19). However, the safety and efficacy of the COVID-19 vaccine in HSCT patients remain to be investigated. We prospectively evaluated the safety and immunogenicity of the BNT162b2 mRNA COVID-19 vaccine (Pfizer BioNTech) in 25 Japanese allogeneic HSCT patients in comparison with 19 healthy volunteers. While anti-S1 antibody titers in almost all healthy volunteers after the second dose were higher than the cut-off value reported previously, levels in HSCT patients after the second dose were diverse. Nineteen patients (76%) had seroconversion of anti-S1 IgG. The median optical density of antibody levels in HSCT patients with low IgG levels (<600 mg/dL), steroid treatment, or low lymphocytes (<1000/μL) was significantly lower than that in the other HSCT patients. There were no serious adverse events (>Grade 3) and no new development or exacerbation of graft-versus-host disease after vaccination. We concluded that the BNT162b2 mRNA vaccine is safe and effective in Japanese allogeneic HSCT patients.
因血液系统疾病接受造血干细胞移植（HSCT）的患者感染2019冠状病毒病（COVID-19）时死亡率很高。然而，COVID-19疫苗在HSCT患者中的安全性和有效性仍有待研究。我们前瞻性地评估了BNT162b2 mRNA COVID-19疫苗（辉瑞BioNTech）在25例日本异基因HSCT患者中的安全性和免疫原性，并与19名健康志愿者进行了比较。虽然几乎所有健康志愿者在接种第二剂疫苗后的抗S1抗体滴度均高于先前报道的临界值，但HSCT患者在接种第二剂疫苗后的抗体水平各不相同。19名患者（76%）出现抗S1 IgG血清转化。IgG水平低（<600 mg/dL）、接受类固醇治疗或淋巴细胞计数低（<1000/μL）的HSCT患者的抗体水平光密度中位数显著低于其他HSCT患者。接种疫苗后未出现严重不良事件（>3级），也没有移植物抗宿主病的新发生或加重。我们得出结论，BNT162b2 mRNA疫苗在日本异基因HSCT患者中是安全有效的。
