title: Lessons learned from clinical trials evaluating pneumococcal conjugate vaccine efficacy against pneumonia and invasive disease.
abstract: This article discusses lessons learned from clinical trials with pneumococcal conjugate vaccines (PCVs). A review of major clinical trials investigating PCV efficacy, this article provides the context to explore challenges associated with studying pneumococcal pneumonia and vaccine efficacy, particularly related to non-bacteremic disease, serotypes, and radiograph interpretation. Throughout these clinical trials, improving the pneumonia diagnosis specificity increased vaccine efficacy estimates. Additional analysis suggests this improvement may come at a cost of detecting much less of the disease burden. The article concludes with a discussion of the potential value of C-reactive protein as an adjunctive marker in measuring PCV efficacy against non-bacteremic pneumococcal pneumonia.
authors.affiliation: University of the Witwatersrand , Department of Science and Technology, South Africa. madhis@hivisa.com
authors.forename: Shabir A
authors.initials: SA
authors.lastname: Madhi
authors.forename: Cynthia G
authors.initials: CG
authors.lastname: Whitney
authors.forename: Hanna
authors.initials: H
authors.lastname: Nohynek
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D002986:Clinical Trials as Topic; D006801:Humans; D022242:Pneumococcal Vaccines / Q000276:immunology* / Q000627:therapeutic use; D011018:Pneumonia, Pneumococcal / Q000378:metabolism / Q000517:prevention & control*; D018074:Vaccines, Conjugate / Q000276:immunology / Q000627:therapeutic use*
chemical_list: D015415:Biomarkers; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate; D002097:C-Reactive Protein