Cordonnier Catherine, Ljungman Per, Juergens Christine, Maertens Johan, Selleslag Dominik, Sundaraiyer Vani, Giardina Peter C, Clarke Keri, Gruber William C, Scott Daniel A, Schmoele-Thoma Beate
Hopital Henri Mondor, Assistance Publique-Hopitaux de Paris, and Université Paris-Est-Créteil, France.
Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
Clin Infect Dis. 2015 Aug 1;61(3):313-23. doi: 10.1093/cid/civ287. Epub 2015 Apr 13.
Life-threatening Streptococcus pneumoniae infections often occur after hematopoietic stem cell transplant (HSCT); vaccination is important for prevention.
In an open-label study, patients (n = 251) 3-6 months after allogeneic HSCT received 3 doses of 13-valent pneumococcal conjugate vaccine (PCV13) at 1-month intervals, a fourth dose 6 months later, and 1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month later. Immunogenicity at prespecified time points and vaccine safety were assessed.
In the evaluable immunogenicity population (N = 216; mean age, 37.8 years), geometric mean fold rises (GMFRs) of immunoglobulin G geometric mean concentrations from baseline to postdose 3 showed significant increases in antibody levels across all PCV13 serotypes (GMFR range, 2.99-23.85; 95% confidence interval lower limit, >1); there were significant declines over the next 6 months, significant increases from predose 4 to postdose 4 (GMFR range, 3.00-6.97), and little change after PPSV23 (GMFR range, 0.86-1.12). Local and systemic reactions were more frequent after dose 4. Six patients experienced serious adverse events possibly related to PCV13 (facial diplegia, injection-site erythema and pyrexia, autoimmune hemolytic anemia, and suspected lack of vaccine efficacy after dose 3 leading to pneumococcal infection), PCV13 and PPSV23 (Guillain-Barré syndrome), or PPSV23 (cellulitis). There were 14 deaths, none related to study vaccines.
A 3-dose PCV13 regimen followed by a booster dose may be required to protect against pneumococcal disease in HSCT recipients. Dose 4 was associated with increased local and systemic reactions, but the overall safety profile of a 4-dose regimen was considered acceptable.
NCT00980655.
危及生命的肺炎链球菌感染常在造血干细胞移植（HSCT）后发生；接种疫苗对预防至关重要。
在一项开放标签研究中，异基因造血干细胞移植后3至6个月的患者（n = 251）每隔1个月接种3剂13价肺炎球菌结合疫苗（PCV13），6个月后接种第4剂，1个月后接种1剂23价肺炎球菌多糖疫苗（PPSV23）。评估预定时间点的免疫原性和疫苗安全性。
在可评估免疫原性的人群（N = 216；平均年龄37.8岁）中，从基线到第3剂后免疫球蛋白G几何平均浓度的几何平均倍数升高（GMFR）显示所有PCV13血清型的抗体水平均显著升高（GMFR范围为2.99至23.85；95%置信区间下限>1）；在接下来的6个月中显著下降，从第4剂前到第4剂后显著升高（GMFR范围为3.00至6.97），接种PPSV23后变化不大（GMFR范围为0.86至1.12）。第4剂后局部和全身反应更频繁。6例患者发生可能与PCV13（面部麻痹、注射部位红斑和发热、自身免疫性溶血性贫血以及怀疑第3剂后疫苗效力不足导致肺炎球菌感染）、PCV13和PPSV23（格林-巴利综合征）或PPSV23（蜂窝织炎）相关的严重不良事件。有14例死亡，均与研究疫苗无关。
可能需要采用3剂PCV13方案并随后加强一剂，以预防HSCT受者的肺炎球菌疾病。第4剂与局部和全身反应增加相关，但4剂方案的总体安全性被认为是可接受的。
NCT00980655。
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