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      Efficacy of Pneumococcal Immunization in Patients with Renal Disease – What Is the Data?

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          Abstract

          Background/Aims: There is an increased incidence of invasive pneumococcal disease in patients with renal allografts, chronic renal insufficiency (CRI), or nephrotic syndrome (NS). Routine pneumococcal immunization (PI) has been recommended for these patients, but the efficacy of PI in this population is not well established. Methods: A review was done of studies that reported the immunologic response, efficacy, or safety of PI in patients with renal allografts, CRI, or NS. Results: On review of 26 published studies of PI in this population, all studies demonstrated a serologic response by the majority of patients to at least some pneumococcal serotypes. Use of steroids did not alter this response. In the studies with a greater than 6-month follow-up, declining antibody titers were consistently reported, and this decline was usually more rapid than in healthy controls. However, because the studies of the efficacy of PI in this population involve small numbers of patients and are not controlled, the significance of this decline in titers is not known. The incidence of serious adverse reactions to PI is very low. Conclusion: Pending more data, patients with renal transplants, CRI, or NS should continue to be offered PI.

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          Most cited references 25

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          Pneumococcal polysaccharide vaccine efficacy. An evaluation of current recommendations.

          To determine pneumococcal polysaccharide vaccine efficacy in selected populations at risk for serious pneumococcal infection for whom vaccination is currently recommended and to assess duration of protection after vaccination. Vaccine efficacy was estimated using indirect cohort analysis to compare the proportion of pneumococcal infections caused by serotypes included in the vaccines of vaccinated and unvaccinated persons who were identified during 14 years of national surveillance. Hospital laboratories in the United States that submitted pneumococcal isolates to the Centers for Disease Control and Prevention between May 1978 and April 1992. A total of 2837 persons older than 5 years who had pneumococcus isolated from blood or cerebrospinal fluid. Overall efficacy for preventing infection caused by serotypes included in the vaccine was 57% (95% confidence interval [CI], 45% to 66%). Efficacy among persons with diabetes mellitus was 84% (95% CI, 50% to 95%); with coronary vascular disease, 73% (95% CI, 23% to 90%); with congestive heart failure, 69% (95% CI, 17% to 88%); with chronic pulmonary diseases, 65% (95% CI, 26% to 83%); and with anatomic asplenia, 77% (95% CI, 14% to 95%). Efficacy was not documented for patients with alcoholism or cirrhosis, sickle cell disease, chronic renal failure, lymphoma, leukemia, or multiple myeloma, although sample sizes were small for these groups. Efficacy for immunocompetent persons older than 65 years was 75% (95% CI, 57% to 85%). Efficacy did not decline with increasing interval after vaccination: 5 to 8 years after vaccination it was 71% (95% CI, 24% to 89%), and 9 years or more after vaccination it was 80% (95% CI, 16% to 95%). Intensified efforts to improve pneumococcal vaccine coverage among certain populations for whom vaccination is currently recommended is indicated, but universal revaccination is not warranted at this time.
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            Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.

            The World Health Organization (WHO) is undertaking a series of consultations on serological criteria for the evaluation and licensure of new formulations/combinations or different vaccination schedules of pneumococcal conjugate vaccines. The lack of a definitive serological correlate of protection and the multiplicity of antigens involved, especially since the clinical efficacy of most of the individual serotypes represented in the only licensed vaccine has not been established, are hindering the formulation of criteria for licensure of new formulations or combinations of the vaccine. This report analyses the various options with their relative merits and drawbacks and provides preliminary recommendations as guidance to regulatory agencies in evaluating these vaccines for the purposes of licensure. More detailed recommendations for production and control of pneumococcal conjugate vaccines, including criteria for evaluation for licensure, are currently being drafted.
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              Historical changes in pneumococcal serogroup distribution: implications for the era of pneumococcal conjugate vaccines.

              Of the 90 pneumococcal serotypes, the 7 in the licensed pneumococcal conjugate vaccine (Prevnar) currently account for >80% of invasive pneumococcal infections among children in the United States. Our objective was to document and explain the changes in pneumococcal serogroup distribution in the United States during the last century. We evaluated temporal trends in the serogroup distribution, using linear regression. Between 1928 and 1998, the proportion of pneumococcal infections caused by the 7 serogroups in the conjugate vaccine increased significantly, from 15% to 59%, in 13 adult studies, and from 53% to 87%, in 19 pediatric studies. The proportion of infections caused by the "epidemic" serogroups (1-3 and 5) decreased significantly, from 71% to 7%, in the adult studies, and from 18% to 2%, in the studies of children. These historical trends in serogroup distribution may be explained by changes in antibiotic use, socioeconomic conditions, the immunocompromised status of populations, and blood-culturing practices.
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                Author and article information

                Journal
                AJN
                Am J Nephrol
                10.1159/issn.0250-8095
                American Journal of Nephrology
                S. Karger AG
                0250-8095
                1421-9670
                2004
                August 2004
                17 September 2004
                : 24
                : 4
                : 402-409
                Affiliations
                Department of Pediatrics, University of Alberta, Edmonton, Alta., Canada
                Article
                79883 Am J Nephrol 2004;24:402–409
                10.1159/000079883
                15273446
                © 2004 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Tables: 3, References: 43, Pages: 8
                Product
                Self URI (application/pdf): https://www.karger.com/Article/Pdf/79883
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