15价肺炎球菌结合疫苗在健康成年人中的安全性、耐受性和免疫原性。
Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults.
作者信息
McFetridge Richard, Meulen Ajoke Sobanjo-Ter, Folkerth Steven D, Hoekstra John A, Dallas Michael, Hoover Patricia A, Marchese Rocio D, Zacholski Donna M, Watson Wendy J, Stek Jon E, Hartzel Jonathan S, Musey Luwy K
机构信息
Merck, Sharp, & Dohme Corp., Whitehouse Station, NJ, USA.
Clinical Research Center of Nevada, Las Vegas, NV, USA.
出版信息
Vaccine. 2015 Jun 4;33(24):2793-9. doi: 10.1016/j.vaccine.2015.04.025. Epub 2015 Apr 23.
BACKGROUND
Pneumococcal disease remains an important health priority despite successful implementation of pneumococcal conjugate vaccines (PCVs) in infant immunization programs, mainly due to the emergence of diseases caused by serotypes not included in licensed PCVs. A 15-valent pneumococcal conjugate vaccine (PCV-15) containing the 7 serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) included in licensed PCV-7 available at study initiation plus 8 additional serotypes (1, 3, 5, 6A, 7F, 19A, 22F, 33F) was developed and evaluated in healthy adults 18-45 years of age.
METHODS
Sixty subjects received one dose of PCV-15 or PCV-7. Injection-site and systemic adverse events (AEs) were collected for 14-days postvaccination and serious AEs were collected for 30-days postvaccination. Safety laboratory tests (hematology, chemistry, and urinalysis) were evaluated prior to vaccination and 14-days postvaccination. Serotype-specific IgG and opsonophagocytic killing activity (OPA) responses to 15 serotypes included in PCV-15 were measured immediately prior to vaccination and 30-days postvaccination.
RESULTS
AE incidences were comparable between vaccine groups although numerically higher frequencies of erythema (33.3% versus 13.3%), swelling (50.0% versus 23.3%), and myalgia (63.3% versus 36.7%) were reported among PCV-15 versus PCV-7 recipients. Majority of AEs, irrespective of vaccine received, were transient and of mild-to-moderate intensity. No clinically significant differences were observed when comparing AE duration and severity. No laboratory abnormalities, vaccine-related SAEs or discontinuations from the study due to AEs were reported. IgG concentrations for the shared serotypes substantially increased postvaccination at comparable levels between recipients of PCV-15 and PCV-7. Substantial increases in antibody (IgG and OPA) responses to 8 serotypes unique to PCV-15 were observed in PCV-15 recipients. Slight increases to 2 serotypes unique to PCV-15, serotypes 6A and 19A, were also noted in PCV-7 recipients.
CONCLUSION
PCV-15 displays an acceptable safety profile and induces IgG and OPA responses to all serotypes included in the vaccine.
背景
尽管肺炎球菌结合疫苗（PCV）已成功应用于婴儿免疫计划，但肺炎球菌疾病仍然是一个重要的健康优先事项，主要原因是出现了由已获许可的PCV中未包含的血清型引起的疾病。一种15价肺炎球菌结合疫苗（PCV-15）被研发出来并在18至45岁的健康成年人中进行评估，该疫苗包含研究开始时已获许可的PCV-7中的7种血清型（4、6B、9V、14、18C、19F和23F）以及另外8种血清型（1、3、5、6A、7F、19A、22F、33F）。
方法
60名受试者接受一剂PCV-15或PCV-7。在接种疫苗后14天收集注射部位和全身不良事件（AE），在接种疫苗后30天收集严重AE。在接种疫苗前和接种疫苗后14天评估安全性实验室检查（血液学、化学和尿液分析）。在接种疫苗前和接种疫苗后30天测量对PCV-15中包含的15种血清型的血清型特异性IgG和调理吞噬杀伤活性（OPA）反应。
结果
尽管PCV-15接种者中报告的红斑（33.3%对13.3%）、肿胀（50.0%对23.3%）和肌痛（63.3%对36.7%）的频率在数值上高于PCV-7接种者，但疫苗组之间的AE发生率相当。无论接种何种疫苗，大多数AE都是短暂的，强度为轻度至中度。在比较AE持续时间和严重程度时未观察到临床显著差异。未报告实验室异常、与疫苗相关的严重AE或因AE而退出研究的情况。PCV-15和PCV-7接种者接种疫苗后，共享血清型的IgG浓度在相当水平上大幅增加。在PCV-15接种者中观察到对PCV-15特有的8种血清型的抗体（IgG和OPA）反应大幅增加。在PCV-7接种者中也注意到对PCV-15特有的2种血清型6A和19A的轻微增加。
结论
PCV-15显示出可接受的安全性概况，并诱导对疫苗中包含的所有血清型的IgG和OPA反应。
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