Immunogenicity of three versus four doses of 13-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine in allogeneic haematopoietic stem cell transplantation recipients: a multicentre, randomized controlled trial

被引：4

作者：

Okinaka, Keiji ^{[1
,2
]}

Akeda, Yukihiro ^{[3
,4
,5
]}

Inamoto, Yoshihiro ^{[1
]}

Fuji, Shigeo ^{[1
]}

Ito, Ayumu ^{[1
]}

Tanaka, Takashi ^{[1
]}

Kurosawa, Saiko ^{[1
]}

Kim, Sung-Won ^{[1
]}

Tanosaki, Ryuji ^{[1
]}

Yamashita, Takuya ^{[1
]}

Ohwada, Chikako ^{[6
,7
]}

Kurata, Keiji ^{[8
]}

Mori, Takeshi ^{[9
,10
]}

Onozawa, Masahiro ^{[11
]}

Takano, Kuniko ^{[12
]}

Yokoyama, Hiroki ^{[13
]}

Koh, Katsuyoshi ^{[14
]}

Nagafuji, Koji ^{[15
]}

Nakayama, Kazutaka ^{[16
]}

Sakura, Toru ^{[17
]}

Takahashi, Tsutomu ^{[18
]}

Oishi, Kazunori ^{[19
,20
]}

Fukuda, Takahiro ^{[1
]}

机构：

[1] Natl Canc Ctr, Dept Hematopoiet Stem Cell Transplantat, Tokyo, Japan

[2] Natl Canc Ctr Hosp East, Div Infect Dis, Chiba, Japan

[3] Osaka Univ, Dept Infect Control & Prevent, Grad Sch Med, Osaka, Japan

[4] Osaka Univ, Res Inst Microbial Dis, Osaka, Japan

[5] Natl Inst Infect Dis, Dept Bacteriol 1, Tokyo, Japan

[6] Chiba Univ Hosp, Dept Hematol, Chiba, Japan

[7] Int Univ Hlth & Welf, Dept Hematol, Sch Med, Narita, Japan

[8] Kobe Univ Hosp, Dept Med Oncol & Hematol, Kobe, Japan

[9] Kobe Univ Hosp, Dept Pediat, Kobe, Japan

[10] Hyogo Prefectural Kobe Childrens Hosp, Dept Hematol & Oncol, Kobe, Japan

[11] Hokkaido Univ Hosp, Dept Hematol, Sapporo, Hokkaido, Japan

[12] Oita Univ, Dept Med Oncol & Hematol, Fac Med, Oita, Japan

[13] Jikei Univ, Div Clin Oncol & Hematol, Sch Med, Tokyo, Japan

[14] Saitama Childrens Med Ctr, Dept Hematol Oncol, Saitama, Japan

[15] Kurume Univ, Dept Med, Div Hematol & Oncol, Sch Med, Kurume, Japan

[16] Nippon Med Coll Hosp, Dept Hematol, Tokyo, Japan

[17] Saiseikai Maebashi Hosp, Leukemia Res Ctr, Maebashi, Japan

[18] Shimane Univ Hosp, Dept Hematol, Izumo, Shimane, Japan

[19] Natl Inst Infect Dis, Infect Dis Surveillance Ctr, Tokyo, Japan

[20] Toyama Inst Hlth, Toyama, Japan

来源：

CLINICAL MICROBIOLOGY AND INFECTION | 2023年 / 29卷 / 04期

关键词：

Allogeneic haematopoietic stem cell; transplantation; Graft-versus-host disease; Immunogenicity; Pneumococcal vaccine; Streptococcus pneumoniae; DISEASE; ADULTS; INFECTIONS; GUIDELINES; SEROTYPES; CHILDREN;

D O I：

10.1016/j.cmi.2022.12.007

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Objective: 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).Methods: 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.Results: 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 in-terval (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.Discussion: 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. Keiji Okinaka, Clin Microbiol Infect 2023;29:482 (c) 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

引用

页码：482 / 489

页数：8

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