Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants |
| |
| Institution: | 1. Soroka University Medical Center, Beer-Shiva, Israel;2. Merck & Co., Inc., Kenilworth, NJ, USA;3. University of Tampere, Tampere, Finland;4. Pediatric Associates of Mt. Carmel, Cincinnati, OH, USA;5. Cottonwood Pediatrics, Murray, UT, USA;1. Department of Medical Microbiology, College of Medicine, Faculty of Health Sciences, University of Manitoba, 727 McDermot Avenue, Winnipeg, Manitoba R3E 3P5, Canada;2. Clinical Microbiology–Health Sciences Centre, Diagnostic Services Manitoba, MS673-820 Sherbrook Street, Winnipeg, Manitoba R3A 1R9, Canada;1. Children University Hospital “Juan Manuel Márquez”, Marianao, Havana 11400, Cuba;1. Children University Hospital “Juan Manuel Márquez”, Marianao, Havana 11400, Cuba;2. Finlay Vaccine Institute, 200 and 21 Street, Playa, Havana 11600, Cuba;3. Tropical Medicine Institute “Pedro Kourí”, Havana, Cuba;4. University Hospital “Juan Manuel Márquez”, Marianao, Havana, Cuba;5. World Health Organization (WHO) Pneumococcal Serology Reference Laboratory, University College London, Institute of Child Health, London, United Kingdom;1. Infectious Disease Center and Department of Clinical Research, National Hospital Organization Mie Hospital, Mie, Japan;2. National Institute of Infectious Diseases, Tokyo, Japan;3. Okinawa Prefectural Nanbu Medical Center & Children''s Medical Center, Okinawa, Japan;4. Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan;5. Section of Pediatrics, Department of Medicine, Division of Oral and Medical Management, Fukuoka Dental College, Fukuoka, Japan;6. Kochi University, Kochi, Japan;7. Department of Pediatrics, Kochi Prefectural Hata-Kenmin Hospital, Kochi, Japan;8. Okayama University Graduate School of Health Sciences, Okayama, Japan;9. Department of Infectious Diseases, Medical Mycology Research Center, Chiba University, Chiba, Japan;10. Department of Pediatrics, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan;11. Department of Pediatrics, Fukushima Medical University School of Medicine, Fukushima, Japan;12. Sapporo City University School of Nursing, Hokkaido, Japan;1. Laboratory for Clinical Research on Infectious Disease, International Research Center for Infectious Diseases, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan;2. Department of Respiratory Medicine, Allergy and Rheumatic Disease, Graduate School of Medicine, Osaka University, Osaka, Japan;3. Department of Pediatrics, Nishi-Kobe Medical Center, Kobe, Japan;4. Division of Control and Treatment of Infectious Diseases, Chiba University Hospital, Chiba, Japan;5. Department of Microbiology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan;6. Department of Pediatrics, Graduate School of Medicine, Gifu University, Gifu, Japan;7. National Mie Hospital, Mie, Japan;8. Department of Bacteriology I, National Institute of Infectious Diseases, Tokyo, Japan;9. Infectious Disease Surveillance Center, National Institute of Infectious Diseases, 1-23-1 Toyama, Shinjyuku, Tokyo 162-8640, Japan;1. University Hospital, Hradec Kralove, Czech Republic;2. University Hospital, Pilsen, Czech Republic;3. GlaxoSmithKline Vaccines, Wavre, Belgium;1. Statistics, Modelling, and Economics Department, Health Protection Services, Public Health England, London, UK;2. Immunisation, Hepatitis, and Blood Safety Department, Health Protection Services, Public Health England, London, UK;3. Respiratory and Vaccine Preventable Bacteria Reference Unit, Microbiology Services, Public Health England, London, UK;4. Immunobiology Section, UCL Institute of Child Health, London, UK |
| |
| Abstract: | BackgroundPediatric use of pneumococcal conjugate vaccines (PCV) has been associated with significant decrease in disease burden. However, disease caused by non-vaccine serotypes has increased. Safety and immunogenicity of 15-valent PCV (PCV15) containing serotypes included in 13-valent PCV (PCV13) plus serotypes 22F and 33F were evaluated in infants (NCT01215188).MethodsInfants received adjuvanted PCV15, nonadjuvanted PCV15, or PCV13 at 2, 4, 6, and 12–15 months of age. Safety was monitored for 14 days after each dose. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured at postdose-3, predose-4, and postdose-4.ResultsSafety profiles were comparable across vaccination groups. At postdose-3, both PCV15 formulations were non-inferior to PCV13 for 10 of 13 shared serotypes but failed non-inferiority for 3 serotypes (6A, 6B, and 19A) based on proportion of subjects achieving IgG GMC ≥0.35 µg/mL. Adjuvanted PCV15 and nonadjuvanted PCV15 were non-inferior to PCV13 for 11 and 8 shared serotypes, respectively, based on postdose 3 comparisons of GMC ratios. PCV15 induced higher antibodies to serotypes 3, 22F, and 33F than PCV13.ConclusionsPCV15 displayed acceptable safety profile and induced IgG and OPA to all 15 vaccine serotypes at levels comparable to PCV13 for 10 of 13 shared serotypes.Study identification: V114-003.CLINICALTRIALS.GOV identifier: NCT01215188. |
| |
| Keywords: | Pneumococcal conjugate vaccine Safety Immunogenicity |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
