Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination.
Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination.
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DOI：
10.1097/qad.0000000000000689
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发表时间：
2015-07-17
期刊：
影响因子：
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通讯作者：
Schmoele-Thoma B
中科院分区：
文献类型：
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作者：
Bhorat AE;Madhi SA;Laudat F;Sundaraiyer V;Gurtman A;Jansen KU;Scott DA;Emini EA;Gruber WC;Schmoele-Thoma B
补充数字内容可在文本中获得，免疫受损的人患肺炎球菌疾病的风险增加。建议将接种疫苗作为降低艾滋病毒感染者患肺炎球菌病风险的重要策略。这项研究评估了三剂13价肺炎球菌结合疫苗(PCV13)和一剂23价肺炎球菌多糖疫苗(PPSV23)在未接种肺炎球菌疫苗的HIV感染者中的安全性和免疫原性。这是一项第三阶段的开放标签单臂研究。肺炎球菌疫苗-幼稚的艾滋病毒感染者，年龄至少6岁，CD_4+T细胞数至少为200 /μL，病毒载量低于50 ，000 拷贝/毫升，接种三剂PCV13，然后每隔一个月接种一剂PPSV23。用免疫球蛋白几何平均浓度(GMCs)和吞噬细胞活性(OPA)测定几何平均滴度(GMT)来评估每次给药后的血清特异性抗肺炎球菌免疫应答。收集PCV13注射部位的局部反应、全身反应和其他不良事件。301人登记并接种了疫苗；279人完成了这项研究。与疫苗前水平相比，在第一剂PCV13后，所有血清型的免疫球蛋白GMCs和OPA GMT均有统计学意义的增加。在PCV13剂量2和3以及PPSV23后，所有血清型的GMC和GMT可比或仅略有增加。大多数局部反应和全身事件的严重程度为轻度至中度。肺炎球菌疫苗的幼稚、HIV感染者对三剂PCV13方案的耐受性很好。在第一次注射PCV13后，观察到对所有血清型的显著免疫反应，随后注射PCV13或PPSV23后，抗体滴度仅略有增加。
Supplemental Digital Content is available in the text Immunocompromised individuals are at an increased risk of pneumococcal disease. Vaccination is recommended as an important strategy to reduce risk of pneumococcal disease in HIV-infected individuals. This study evaluated the safety and immunogenicity of three 13-valent pneumococcal conjugate vaccine (PCV13) doses followed by one dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at 1-month intervals in pneumococcal vaccine-naive, HIV-infected individuals. This was a phase 3, open-label, single-arm study. Pneumococcal vaccine-naive, HIV-infected individuals at least 6 years of age with CD4+ T-cell count at least 200 cells/μl and viral load less than 50 000 copies/ml received three doses of PCV13 followed by one dose of PPSV23 at 1-month intervals. Serotype-specific antipneumococcal immune responses were assessed by IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) assay geometric mean titres (GMTs) after each dose. Local reactions at the PCV13 injection site, systemic and other adverse events were collected. Three hundred and one individuals were enrolled and vaccinated; 279 completed the study. Statistically significant increases in IgG GMCs and OPA GMTs were observed for all serotypes after dose 1 of PCV13 compared with prevaccine levels. GMCs and GMTs were comparable or only modestly increased for all serotypes after PCV13 doses 2 and 3 and after PPSV23. The majority of local reactions and systemic events were mild to moderate in severity. A three-dose regimen of PCV13 was well tolerated in pneumococcal vaccine-naive, HIV-infected individuals. Significant immune responses to all serotypes were observed following the first dose of PCV13, with only modest increases in antibody titres following subsequent PCV13 or PPSV23 administration.