Randomized clinical trial of a single versus a double dose of 13-valent pneumococcal conjugate vaccine in adults 55 through 74?years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine |
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| Institution: | 1. Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States;2. Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States;3. Division of Infectious Diseases, Allergy, & Immunology, Saint Louis University School of Medicine, and St. Louis VA Medical Center, St. Louis, MO, United States;4. University of Iowa and Iowa City VA Medical Center, Iowa City, IA, United States;5. Vanderbilt Vaccine Research Program, Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, United States;6. Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States;7. The Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, School of Medicine, Emory University, Decatur, GA, United States;8. Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States;9. The Emmes Corporation, Rockville, MD, United States;1. Laboratory of Molecular Epidemiology, School of Public Health, Guangdong Pharmaceutical University, Guangzhou, China;2. Department of Laboratory, Liuzhou Maternity and Child Healthcare Hospital, Liuzhou, China;1. Hautzentrum Dülmen, Praxisklinik Doctor Bockhorst/Doctor Dominicus, Vollenstrasse 8, 48249 Dülmen, Germany;2. National Network of Clinical Investigation in Vaccinology (REIVAC), Institut National de la Santé et de la Recherche Médicale (INSERM), France;3. Centre d’Investigation Clinique (CIC), INSERM, CHRU Montpellier Hôpital Saint-Eloi 80, av. Augustin Fliche, 34295 Montpellier Cedex 5, France;4. Sanofi Pasteur MSD, 162, avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France;1. Charles University in Prague—2nd Faculty of Medicine, V Úvalu 84, 150 06 Prague 5, Czech Republic;2. Institute for Clinical and Experimental Medicine, Vídeňská 1958/9, 140 21 Prague 4, Czech Republic;1. Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea;2. Asian Pacific Influenza Institute (APII), Korea University College of Medicine, Seoul, Republic of Korea;3. Hallym University College of Medicine, Seoul, Republic of Korea;4. St. Vincent’s Hospital, Catholic University of Korea College of Medicine, Suwon, Gyeonggi-do, Republic of Korea;1. National Reference Centre for Streptococcus pneumoniae, University Hospitals Leuven, Leuven, Belgium;2. Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium;3. Department Epidemiology of Infectious Diseases, Sciensano, Brussels, Belgium;4. Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Hasselt, Belgium;5. Interuniversity Institute for Biostatistics and Statistical Bioinformatics, KU Leuven, University of Leuven and Universiteit Hasselt, Leuven, Belgium;6. Hôpital Universitaire des Enfants Reine Fabiola, Unité de Maladies Infectieuses Pédiatriques, Université Libre de Bruxelles, Brussels, Belgium;1. Centre for Inflammatory Diseases, School of Clinical Sciences, Monash University, 246 Clayton Road, Clayton, Victoria 3168, Australia;2. Monash Infectious Diseases, Monash Health, 246 Clayton Road, Clayton, Victoria 3168, Australia;3. Department of Nephrology, Monash Health, 246 Clayton Road, Clayton, Victoria 3168, Australia |
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| Abstract: | IntroductionIn older adults, prior administration of 23-valent pneumococcal polysaccharide vaccine (PPSV23) blunts the opsonophagocytic antibody (OPA) response to subsequent administration of 13-valent pneumococcal conjugate vaccine (PCV13). To determine whether a higher dose of PCV13 could mitigate this effect in adults 55 through 74 years of age, we compared OPA responses to a double dose of PCV13 in persons previously vaccinated with PPSV23 with responses to a single dose of PCV13 in previously vaccinated persons, and with a single dose in PPSV23 naïve persons.MethodsSubjects previously vaccinated with PPSV23 were randomly assigned to receive either a single injection or two concurrent injections of 0.5 mL PCV13. Naïve subjects received a single injection of 0.5 mL PCV13. Serotype-specific OPA responses to 12 of the PCV13 serotypes were assessed on samples collected on Day 29 and Day 181. Comparisons of the OPA titers between study groups were based on the lower bound of the 95% confidence interval of the log geometric mean ratio to define superiority (>1) and non-inferiority (>0.5).ResultsAt Day 29, the OPA responses to one dose in previously vaccinated (n = 284) versus one dose in naïve subjects (n = 311) achieved the threshold for non-inferiority for only 3 of the 12 serotypes. In previously vaccinated subjects, responses to a double dose (n = 288) versus a single dose met the threshold for superiority for 7 serotypes. The responses to a double dose in previously vaccinated subjects versus a single dose in naïve subjects met the threshold for non-inferiority for 9 serotypes.ConclusionsThere is a dose response to PCV13 in older adults and the higher response to a double dose in previously vaccinated adults is non-inferior to that of a single dose in naïve adults for 9 of the 12 PCV13 serotypes evaluated. |
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| Keywords: | Pneumococcal vaccine |
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