Phase 1 trial of a 20-valent pneumococcal conjugate vaccine in healthy adults |
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| Institution: | 1. Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States;2. Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States;3. Pfizer Clinical Research Unit, Pfizer, Inc., New Haven, CT, United States;1. Immunisation, Hepatitis, and Blood Safety Department, Public Health England, London, UK;2. Statistics, Modelling, and Economics Department, Public Health England, London, UK;3. Respiratory and Vaccine Preventable Bacterial Reference Unit, Public Health England, London, UK;4. Paediatric Infectious Diseases Research Group, St George''s University of London, London, UK;5. Meningococcal Reference Unit, Public Health England, Manchester, UK;1. Institute of Infectious Diseases and Infection Control, Jena University Hospital, Jena, Germany;2. Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria;3. Division of Pulmonology, Medical Department I, University Hospital Carl Gustav Carus, Dresden, Germany;4. CAPNETZ STIFTUNG, Hannover, Germany;5. Research Group Clinical Epidemiology, Center for Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany;6. Thorax Center in the Ruhr Area, Department of Respiratory Medicine and Infectious Diseases, Evangelikal Protestant Hospital in Herne and Augusta Hospital in Bochum, Bochum, Germany;7. Medical Department I, Department of Respiratory Medicine, Goethe University Hospital, Frankfurt/Main, Germany;8. Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), Member of the German Center for Lung Research (DZL), Germany;9. Department of Infectious Diseases and Microbiology, University Hospital Schleswig-Holstein, Lübeck, Germany;10. German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Germany;11. Department of Infectious Diseases and Pulmonary Medicine, and Division of Pulmonary Inflammation, Charité – Universitätsmedizin Berlin, Berlin, Germany;12. Department of Pneumology, Hannover Medical School, Hannover, Germany;1. Pfizer Vaccines, Collegeville, PA, USA;2. Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, The Netherlands;3. Centers for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA;4. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;5. Department of Medicine, Pulmonary and Critical Care, Northwestern University Feinberg School of Medicine, Chicago, IL, USA;6. Julius Clinical, Academic Contract Research Organization, Zeist, The Netherlands;7. Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, The Netherlands;1. Center for American Indian Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States;2. GSK, Wavre, Belgium;3. XPE Pharma & Science c/o GSK, Wavre, Belgium;1. Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada;2. Faculty of Medicine, University of British Columbia, Vancouver, Canada;3. Faculty of Sciences, University of British Columbia, Vancouver, Canada |
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| Abstract: | IntroductionStreptococcus pneumoniae is a leading cause of bacteremia, bacterial pneumonia, and meningitis, and is associated with substantial morbidity and mortality, particularly in those under 2 years of age and those over 65 years of age. While significant progress against S. pneumoniae-related disease has been made as a result of the introduction of pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), there remains value in further expanding pneumococcal vaccine serotype coverage. Here we present the first report of a 20-valent pneumococcal conjugate vaccine (PCV20) containing capsular polysaccharide conjugates present in PCV13 as well as 7 new serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) which are important contributors to pneumococcal disease.MethodsThis Phase I first-in-human study was a randomized, controlled, observer-blinded study with a two-arm parallel design to assess the safety, tolerability, and immunogenicity of PCV20 in adults. A total of 66 healthy adults 18–49 years of age with no history of pneumococcal vaccination were enrolled and randomized to receive a single dose of PCV20 or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) control. Local injection site reactions, select systemic symptoms, laboratory studies, and adverse events were assessed. Opsonophagocytic activity (OPA) titers and IgG concentrations were measured in sera collected prior to, and approximately one month (28–35 days) after vaccination.ResultsVaccination with PCV20 elicited substantial IgG and functional bactericidal immune responses as demonstrated by increases in IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) to the 20 vaccine serotypes. The overall safety profile of PCV20 was similar to Tdap, and generally consistent with that observed after PCV13 administration.ConclusionsVaccination with PCV20 was well tolerated and induced substantial functional (OPA) and IgG responses to all vaccine serotypes. There were no safety issues identified in this Phase 1 study, and the data supported further evaluation of PCV20. |
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| Keywords: | PCV20 Pneumococcal conjugate vaccine |
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