2016-08-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/658724摘要：為預防器官移植患者發⽣肺炎鏈球菌感染，美國成⼈疫苗接種諮詢委員會建議患者應接種1 劑13 價蛋⽩接合型肺炎鏈球菌疫苗，並於⾄少8 周後再⾏施打23 價多醣體肺炎鏈球菌疫苗。但⽬前相關研究仍關研究甚少，且是否移植前給予疫苗較佳仍未知。故本研究欲評估器官移植患者/候選者施打13 價蛋⽩接合型肺炎鏈球菌疫苗後，產⽣免疫功能的狀況及安全性。本研究收納接受移植評估時，臨床狀況穩定之器官移植候選者及移植六個⽉後，臨床狀況穩定之器官移植患者，給予⼀劑13 價蛋⽩接合型肺炎鏈球菌疫苗。本研究紀錄施打後七天內發⽣的症狀，及測量施打前，施打後⼀、三、六、九、⼗⼆個⽉對四種⾎清型(6B, 14, 19F and 23F)產⽣的抗體效價。陽性抗體反應定義為施打後⾎清型抗體效價和施打疫苗前的抗體效價(即基礎值)相⽐，有兩倍或以上的上升，且抗體效價需⼤於等於1000 ng/ml 。所有13 價蛋⽩接合型肺炎鏈球菌疫苗接受者將被分為三組，追蹤過程中未接受器官移植的器官移植候選者(組⼀)，器官移植患者(組⼆)，追蹤過程中有接受器官移植的器官移植候選者(組三)。根據本研究前幾年(2013-2014)的初步結果顯⽰，施打後⾎清型抗體效價會隨著時間和器官移植後下降，故本研究欲對組⼆參與者，在第⼀劑13 價蛋⽩接合型肺炎鏈球菌疫苗施打⼀年後，追加⼀劑13價蛋⽩接合型肺炎鏈球菌疫苗。對組三參與者，在移植後⼀年後，追加⼀劑13 價蛋⽩接合型肺炎鏈球菌疫苗。之後紀錄施打後七天內發⽣的症狀，及測量施打前，施打後⼀、三、六、九、⼗⼆個⽉對四種⾎清型(6B, 14, 19Fand 23F)產⽣的抗體效價。最後，將進⾏⼀病例對照研究以⽐較接受13 價蛋⽩接合型肺炎鏈球菌疫苗施打者和未接受疫苗施打者感染發⽣率及死亡率的差別。<br> Abstract: The United States Advisory Committee on Immunization Practices recommends that 13-valentpneumococcal conjugated vaccine (PCV13) be given in addition to 23-valent pneumococcal polysaccharidevaccine to immunocompromised adults, such as solid organ transplant (SOT) recipients, to prevent invasivepneumococcal diseases. However, data regarding this are sparse and it is unknown whether betterimmunogenicity could be achieved if vaccination is given before transplantation. The present study aimed toassess the immunogenicity and safety of PCV13 in SOT candidates and recipients. Consecutive patientsreceiving pre-SOT evaluation and SOT receipts with stable clinical conditions 6 months post transplantationwill be invited to participate the study. Symptoms developing within 7 days after one dose PCV13 andanti-capsular antibody responses against 4 serotypes (6B, 14, 19F and 23F) at baseline and 1, 3, 6, 9, 12months after vaccination will be recorded, respectively. Significant antibody responses are defined as 2-foldor greater increase of antibody levels and at least > 1000 nanogram/mL after vaccination compared with thebaseline plus an level ≥1000 ng/ml. All PCV13 receivers will be grouped into 3 groups: SOT candidateswithout transplantation (Group 1), SOT recipients (Group 2), and SOT candidates with transplantation(Group 3). Preliminary results of the prior study (2013-2014) showed that pneumococcal titers declined withtime and after transplantation, so a booster PCV13 will be given to Group 2 (one year after the first PCV13),and Group 3 (one year after transplantation). Symptoms developing within 7 days after one dose PCV13 andanti-capsular antibody responses against 4 serotypes (6B, 14, 19F and 23F) before and 1, 3, 6, 9, 12 monthsafter booster will be recorded respectively. Lastly, a case-control study will be conducted to compare theinfection incidence and mortality between PCV13 receivers and non-receivers.器官移植患者/候選者施打13 價蛋⽩接合型肺炎鏈球菌疫苗肺炎鏈球菌感染solid organ transplant candidates/recipients13-valent pneumococcal conjugate vaccineinvasive pneumococcal disease