Okinaka Keiji, Akeda Yukihiro, Inamoto Yoshihiro, Fuji Shigeo, Ito Ayumu, Tanaka Takashi, Kurosawa Saiko, Kim Sung-Won, Tanosaki Ryuji, Yamashita Takuya, Ohwada Chikako, Kurata Keiji, Mori Takeshi, Onozawa Masahiro, Takano Kuniko, Yokoyama Hiroki, Koh Katsuyoshi, Nagafuji Koji, Nakayama Kazutaka, Sakura Toru, Takahashi Tsutomu, Oishi Kazunori, Fukuda Takahiro
Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan; Division of Infectious Diseases, National Cancer Center Hospital East, Chiba, Japan.
Department of Infection Control and Prevention, Osaka University Graduate School of Medicine, Osaka, Japan; Research Institute for Microbial Diseases, Osaka University, Osaka, Japan; Department of Bacteriology I, National Institute of Infectious Diseases, Tokyo, Japan.
Clin Microbiol Infect. 2023 Apr;29(4):482-489. doi: 10.1016/j.cmi.2022.12.007. Epub 2022 Dec 8.
This multicentre, phase 2, randomized, controlled study of allogeneic haematopoietic stem cell transplantation (allo-HSCT) recipients compared the immunogenicity of two anti-pneumococcal vaccine regimens: four doses of 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) (3+1+1 experimental group), and three doses of PCV13 followed by PPSV23 (3+0+1 group).
Allo-HSCT recipients without active graft-versus-host disease at enrolment were eligible. The primary endpoint was the IgG response rate (≥0.20 mg/mL) for all eight measured serotypes at 5 months after the PPSV23 booster.
Seventy-two recipients were randomized, and seventy recipients who received over one PCV13 dose were analysed. The mean ages were 47.2 years (standard deviation, 14.4) in the 3+1+1 group (n = 35) and 49.0 years (standard deviation, 14.3) in the 3+0+1 group (n = 35). There was no significant difference in the overall IgG response rate at 5 months after the PPSV23 booster between the 3+1+1 and 3+0+1 groups (100% (26/26) vs. 93% (27/29), respectively, relative risk (RR): 1.07; 95% confidence interval (CI): 0.97-1.19). This rate was high immediately before the PPSV23 booster in the 3+1+1 group (100% (26/26) compared with 81% (21/26), respectively, RR: 1.24; 95% CI: 1.03-1.49), but this difference disappeared 1 month after the PPSV23 booster (100% (26/26) vs. 97% (28/29), respectively, RR: 1.04; 95% CI; 0.97-1.11). No serious adverse events leading to study dropout occurred.
We were not able to determine the efficacy of the experimental arm based on the IgG response rate at 5 months after the PPSV23 booster in allo-HSCT recipients.
本多中心、2期、随机对照研究对异基因造血干细胞移植（allo-HSCT）受者的两种抗肺炎球菌疫苗接种方案的免疫原性进行了比较：4剂13价肺炎球菌结合疫苗（PCV13），随后接种23价肺炎球菌多糖疫苗（PPSV23）（3+1+1试验组），以及3剂PCV13，随后接种PPSV23（3+0+1组）。
入组时无活动性移植物抗宿主病的allo-HSCT受者符合条件。主要终点是PPSV23加强免疫后5个月时所有8种检测血清型的IgG反应率（≥0.20 mg/mL）。
72名受者被随机分组，对70名接受超过1剂PCV13的受者进行了分析。3+1+1组（n = 35）的平均年龄为47.2岁（标准差，14.4），3+0+1组（n = 35）的平均年龄为49.0岁（标准差，14.3）。在PPSV23加强免疫后5个月时，3+1+1组和3+0+1组的总体IgG反应率无显著差异（分别为100%（26/26）和93%（27/29），相对风险（RR）：1.07；95%置信区间（CI）：0.97-1.19）。在PPSV23加强免疫前，3+1+1组的这一反应率较高（分别为100%（26/26）和81%（21/26），RR：1.24；95%CI：1.03-1.49），但在PPSV23加强免疫1个月后这一差异消失（分别为100%（26/26）和97%（28/29），RR：1.04；95%CI：0.97-1.11）。未发生导致研究退出的严重不良事件。
我们无法根据allo-HSCT受者在PPSV23加强免疫后5个月时的IgG反应率来确定试验组的疗效。
