Department of Medical Sciences, Section of Hematology, Uppsala University, Uppsala, Sweden.
Department of Medicine, Section of Hematology, Örebro University Hospital, Örebro, Sweden.
Vaccine. 2018 Jun 14;36(25):3701-3707. doi: 10.1016/j.vaccine.2018.05.012. Epub 2018 May 7.
To determine if patients with untreated chronic lymphocytic leukemia (CLL) benefit from vaccination with a 13-valent pneumococcal conjugated vaccine (PCV13), Prevenar13®, compared to a 23-valent pneumococcal polysaccharide vaccine (PPSV23), Pneumovax®, in terms of immune response.
Streptococcus pneumoniae causes substantial morbidity in patients with CLL, a group known to respond poorly to polysaccharide vaccines. Comparative studies with conjugated vaccines are lacking.
128 treatment naïve CLL patients from eight hematology clinics in Sweden were randomized to vaccination with PCV13 (n = 63) or PPSV23 (n = 65) after stratification by IgG level and CLL clinical stage (Rai). Blood samples for evaluation of immune response were obtained at baseline, and at one and six months after vaccination. Analyses for each of the 12 pneumococcal serotypes common for PCV13 and PPSV23 were performed by opsonophagocytic assay (OPA) and enzyme-linked immunosorbent assay (ELISA).
PCV13 elicited a superior immune response than PPSV23 in 10/12 serotypes one month after vaccination and in 5/12 serotypes six months after vaccination, measured as OPA geometric mean titers (GMTs). Geometric mean concentrations of serotype-specific IgG antibodies elicited by PCV13 as measured by ELISA, were higher than those elicited by PPSV23 in half of the common serotypes, both after one and six months. PPSV23 did not trigger a better immune response than PCV13 for any of the serotypes, regardless of analysis method or time point of analysis. Negative predictive factors for vaccination response were hypogammaglobulinemia and long disease duration. Both vaccines were well tolerated.
In patients with previously untreated CLL, the efficacy of PCV13 in terms of immune response is superior to PPSV23 for most serotypes common for the two vaccines. We therefore propose that PCV13 should be included in vaccination programs against Streptococcus pneumoniae for CLL patients and administered as early as possible during the course of the disease.
确定未经治疗的慢性淋巴细胞白血病（CLL）患者接种 13 价肺炎球菌结合疫苗（PCV13）[沛儿 13]与接种 23 价肺炎球菌多糖疫苗（PPSV23）[沛儿 23]相比，在免疫应答方面是否获益。
肺炎链球菌可导致 CLL 患者出现大量发病，而该人群对多糖疫苗反应不佳。缺乏与结合疫苗的对照研究。
128 名来自瑞典 8 家血液科诊所的初治 CLL 患者，根据 IgG 水平和 CLL 临床分期（Rai）进行分层，随机分为 PCV13（n=63）或 PPSV23（n=65）疫苗接种组。在接种前和接种后 1 个月及 6 个月时采集血样，用于评价免疫应答。采用噬菌体抗体效价测定法（OPA）和酶联免疫吸附试验（ELISA）分析每 12 种针对 PCV13 和 PPSV23 的常见肺炎球菌血清型。
接种后 1 个月时，10/12 种血清型的 PCV13 免疫应答优于 PPSV23，6 个月时，5/12 种血清型的 PCV13 免疫应答优于 PPSV23，这两项结果均以 OPA 几何平均滴度（GMT）表示。PCV13 诱导的血清型特异性 IgG 抗体的几何平均浓度，通过 ELISA 检测，在半数常见血清型中，1 个月和 6 个月时，均高于 PPSV23。无论采用何种分析方法或分析时间点，PPSV23 均不能引发比 PCV13 更好的免疫应答。接种反应的阴性预测因素是低丙种球蛋白血症和疾病持续时间长。两种疫苗均具有良好的耐受性。
对于未经治疗的 CLL 患者，PCV13 对大多数常见血清型的免疫应答效果优于 PPSV23。因此，我们建议将 PCV13 纳入 CLL 患者肺炎链球菌疫苗接种计划，并在疾病过程中尽早进行接种。
