Subhashis Mitra, Gary E Stein, Shyam Bhupalam, Daniel H Havlichek
{"title":"13价肺炎球菌结合疫苗对50岁及以上终末期肾病透析患者的免疫原性","authors":"Subhashis Mitra, Gary E Stein, Shyam Bhupalam, Daniel H Havlichek","doi":"10.1128/CVI.00153-16","DOIUrl":null,"url":null,"abstract":"<p><p>Patients with end-stage renal disease (ESRD) and on dialysis are at increased risk of pneumococcal disease. We evaluated the immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) in this population. Eligible patients with ESRD and on dialysis were given a single dose of PCV13. The concentrations of serum antibodies against 13 pneumococcal capsular polysaccharides were measured at the baseline and at 2 and 12 months postvaccination. A response to the vaccine was defined as a ≥2-fold increase in antibody concentration from that at the baseline and an absolute postvaccination value of at least 1 μg/ml. Seventeen patients completed the study. Increases in the concentrations of antibodies to the vaccine serotype were demonstrated 2 months after vaccination. The geometric mean antibody concentrations at 12 months postvaccination declined by 38% to 72% compared to those measured at 2 months postvaccination. A response to at least 1 serotype in the vaccine was seen in all patients at both 2 and 12 months postvaccination. The overall rate of the response to each individual vaccine serotype varied between 23.5% and 94.1% at 2 months postvaccination and 23.5% and 65% at 12 months postvaccination. Pain at the injection site was the most common local reaction. Vaccination with PCV13 induces antibody responses to vaccine serotypes in patients with ESRD and on dialysis at 2 months postvaccination. However, the decline in antibody concentrations at 12 months postvaccination with a conjugate pneumococcal vaccine requires further study. (This study has been registered at ClinicalTrials.gov under registration no. NCT01974817.).</p>","PeriodicalId":10271,"journal":{"name":"Clinical and Vaccine Immunology","volume":"23 11","pages":"884-887"},"PeriodicalIF":0.0000,"publicationDate":"2016-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1128/CVI.00153-16","citationCount":"29","resultStr":"{\"title\":\"Immunogenicity of 13-Valent Conjugate Pneumococcal Vaccine in Patients 50 Years and Older with End-Stage Renal Disease and on Dialysis.\",\"authors\":\"Subhashis Mitra, Gary E Stein, Shyam Bhupalam, Daniel H Havlichek\",\"doi\":\"10.1128/CVI.00153-16\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Patients with end-stage renal disease (ESRD) and on dialysis are at increased risk of pneumococcal disease. We evaluated the immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) in this population. Eligible patients with ESRD and on dialysis were given a single dose of PCV13. The concentrations of serum antibodies against 13 pneumococcal capsular polysaccharides were measured at the baseline and at 2 and 12 months postvaccination. A response to the vaccine was defined as a ≥2-fold increase in antibody concentration from that at the baseline and an absolute postvaccination value of at least 1 μg/ml. Seventeen patients completed the study. Increases in the concentrations of antibodies to the vaccine serotype were demonstrated 2 months after vaccination. The geometric mean antibody concentrations at 12 months postvaccination declined by 38% to 72% compared to those measured at 2 months postvaccination. A response to at least 1 serotype in the vaccine was seen in all patients at both 2 and 12 months postvaccination. The overall rate of the response to each individual vaccine serotype varied between 23.5% and 94.1% at 2 months postvaccination and 23.5% and 65% at 12 months postvaccination. Pain at the injection site was the most common local reaction. Vaccination with PCV13 induces antibody responses to vaccine serotypes in patients with ESRD and on dialysis at 2 months postvaccination. However, the decline in antibody concentrations at 12 months postvaccination with a conjugate pneumococcal vaccine requires further study. (This study has been registered at ClinicalTrials.gov under registration no. NCT01974817.).</p>\",\"PeriodicalId\":10271,\"journal\":{\"name\":\"Clinical and Vaccine Immunology\",\"volume\":\"23 11\",\"pages\":\"884-887\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2016-11-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1128/CVI.00153-16\",\"citationCount\":\"29\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Vaccine Immunology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1128/CVI.00153-16\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2016/11/1 0:00:00\",\"PubModel\":\"Print\",\"JCR\":\"Q2\",\"JCRName\":\"Biochemistry, Genetics and Molecular Biology\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Vaccine Immunology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1128/CVI.00153-16","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2016/11/1 0:00:00","PubModel":"Print","JCR":"Q2","JCRName":"Biochemistry, Genetics and Molecular Biology","Score":null,"Total":0}
Immunogenicity of 13-Valent Conjugate Pneumococcal Vaccine in Patients 50 Years and Older with End-Stage Renal Disease and on Dialysis.
Patients with end-stage renal disease (ESRD) and on dialysis are at increased risk of pneumococcal disease. We evaluated the immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) in this population. Eligible patients with ESRD and on dialysis were given a single dose of PCV13. The concentrations of serum antibodies against 13 pneumococcal capsular polysaccharides were measured at the baseline and at 2 and 12 months postvaccination. A response to the vaccine was defined as a ≥2-fold increase in antibody concentration from that at the baseline and an absolute postvaccination value of at least 1 μg/ml. Seventeen patients completed the study. Increases in the concentrations of antibodies to the vaccine serotype were demonstrated 2 months after vaccination. The geometric mean antibody concentrations at 12 months postvaccination declined by 38% to 72% compared to those measured at 2 months postvaccination. A response to at least 1 serotype in the vaccine was seen in all patients at both 2 and 12 months postvaccination. The overall rate of the response to each individual vaccine serotype varied between 23.5% and 94.1% at 2 months postvaccination and 23.5% and 65% at 12 months postvaccination. Pain at the injection site was the most common local reaction. Vaccination with PCV13 induces antibody responses to vaccine serotypes in patients with ESRD and on dialysis at 2 months postvaccination. However, the decline in antibody concentrations at 12 months postvaccination with a conjugate pneumococcal vaccine requires further study. (This study has been registered at ClinicalTrials.gov under registration no. NCT01974817.).
期刊介绍:
Cessation. First launched as Clinical and Diagnostic Laboratory Immunology (CDLI) in 1994, CVI published articles that enhanced the understanding of the immune response in health and disease and after vaccination by showcasing discoveries in clinical, laboratory, and vaccine immunology. CVI was committed to advancing all aspects of vaccine research and immunization, including discovery of new vaccine antigens and vaccine design, development and evaluation of vaccines in animal models and in humans, characterization of immune responses and mechanisms of vaccine action, controlled challenge studies to assess vaccine efficacy, study of vaccine vectors, adjuvants, and immunomodulators, immune correlates of protection, and clinical trials.