Randomized study of immune responses to two Tdap vaccines among adolescents primed with DTaP and comparison with results among adolescents primed with DTwP |
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| Institution: | 1. US Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA;2. Department of Health Policy, Vanderbilt University School of Medicine, Nashville, TN, USA;3. Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA;4. Global Medical Affairs, Sanofi Pasteur, Swiftwater, PA, USA;1. Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands;2. Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, The Netherlands;3. Netherlands Reference Laboratory of Bacterial Meningitis, Academic Medical Center, Amsterdam, The Netherlands;1. Pediatric Infectious Diseases Unit, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Madiol University, Bangkok Noi, Bangkok, Thailand;2. Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Ratchathewi, Bangkok, Thailand;3. Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Ratchathewi, Bangkok, Thailand;4. BioNet-Asia, Bangjak, Prakanong, Bangkok, Thailand;1. Vaccine Research Center, FM3/Biokatu 10, 33014 University of Tampere, Tampere, Finland;2. Vaccine Evaluation Unit, Public Health England, Clinical Sciences Building 2, Manchester Royal Infirmary, Manchester, UK;3. Sanofi Pasteur Inc., Global Clinical Immunology, Discovery Drive, Swiftwater, PA, USA;4. Sanofi Pasteur MSD, 162 avenue Jean Jaures, CS 50712, 69367 Lyon Cedex 07, France;1. Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands;2. Department of Paediatrics, Spaarne Hospital, Hoofddorp, the Netherlands;3. Department of Paediatric Immunology and Infectious Diseases, Wilhelmina Children’s Hospital, Utrecht, the Netherlands;1. Translational Pediatrics and Infectious Diseases, Department of Pediatrics, Hospital Clinico Universitario de Santiago de Compostela, c/ A Choupana s.n., 15706 Santiago de Compostela, Spain;2. Sanofi Pasteur MSD, 162 Avenue Jean Jaurès, CS 50712, 69367 Lyon Cedex 07, France;3. Manchester Medical Microbiology Partnership, Public Health England, PO Box 209, Clinical Sciences Building, Manchester Royal Infirmary, Manchester M13 9WZ, UK |
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| Abstract: | BackgroundIt has been reported that persons primed with acellular (DTaP) pertussis vaccines have reduced duration of pertussis protection compared with those primed with whole-cell (DTwP) vaccines. However, due to the rapid transition to acellular vaccines, studies attempting directly to compare protection among DTaP-primed vs DTwP-primed individuals are subject to confounding by age and other limitations of ecological studies. Using validated assay results and stored sera from multiple Tdap studies, we evaluated two licensed Tdap vaccines among DTaP-primed adolescents to allow comparison with results obtained in the same laboratory from earlier studies involving DTwP-primed adolescents.MethodsParticipants 11–12 years of age who had received exactly 5 doses of DTaP vaccine prior to 7 years of age were randomly assigned in 2012 to receive one of two licensed Tdap vaccines. Serum specimens obtained pre- and post-vaccination were assayed for responses to the vaccines. Current results were then compared to results obtained in the same laboratory from prior randomized Tdap studies conducted among adolescents primed with DTwP or DTaP.ResultsBoth Tdap vaccines produced strong antibody responses to diphtheria and tetanus; responses to contained pertussis antigens were consistent with the differing levels of those antigens in each Tdap vaccine. However, postvaccination pertussis antibody responses were as much as 71% lower in these DTaP-primed adolescents compared with responses among DTwP-primed adolescents in a prior study of the same two Tdap vaccines. In contrast, results from the present study were similar to those seen in another study of Tdap among DTaP-primed adolescents.DiscussionTaken together, these results from randomized clinical trials provide direct evidence of reduced antibody responses to both licensed Tdap vaccines among adolescents primed with DTaP vaccine, compared with adolescents primed with DTwP vaccine.Clinical trial registry number: ClinicalTrials.gov, NCT01629589. |
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| Keywords: | Pertussis vaccine Vaccines acellular Tdap vaccine Immunogenicity |
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