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Immunogenicity and persistence of immunity of a quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children |
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| Institution: | 1. School of Public Health and Community Medicine, Faculty of Medicine, University of New South Wales, Kensington, NSW 2052, Australia;2. Dept Gastroenterology Children’s Hospital at Westmead, Hawkesbury Rd, Westmead NSW 2145, Australia;3. Nephrology, Sydney Children’s Hospital, Randwick, High St, Randwick NSW 2031, Australia;4. School of Women’s & Children’s Health, Faculty of Medicine, University of New South Wales, Kensington, NSW 2052, Australia;5. The Women’s and Children’s Hospital and Robinson Research Institute and School of Medicine, The University of Adelaide, 55 King William Road, North Adelaide 5006, Australia;6. College of Public Service and Community Solutions, Arizona State University, USA;1. Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital “Luigi Sacco”, Università di Milano, 20157 Milan, Italy;2. Scientific Institute, IRCCS E. Medea, 23842 Bosisio Parini, Lecco, Italy;3. Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, Consiglio Nazionale delle Ricerche Institute of Neuroscience, University Hospital “Luigi Sacco”, Università di Milano, 20157 Milan, Italy;1. Public Health Ontario, Toronto, ON, Canada;2. Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada;3. Immunization Policy and Programs, Ontario Ministry of Health and Long-Term Care, Toronto, ON, Canada;1. Section of Pediatric Infectious Diseases, Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, United States;2. Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA 02115, United States;3. Department of Pediatrics, University of California Los Angeles, Los Angeles, CA 19954, United States;4. Formerly Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA 02115, United States;5. Office of Science, Food & Drug Administration; Silver Spring, MD 20993, United States;6. Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD, United States;7. Quest Diagnostics, Baltimore, MD, United States;8. Merck & Co., Inc., Kenilworth, NJ, United States;9. Section of Pediatric Infectious Diseases, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, United States;10. Section of Pediatric Infectious Diseases, Departments of Pediatrics, Medicine, and Pathology, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, United States;1. Department of Pediatrics, Luigi Sacco Hospital, University of Milan, Italy;2. Department of Immunology, Luigi Sacco Hospital, University of Milan, Italy;3. Don C Gnocchi Foundation, IRCCS, Milan, Italy;4. Clinical Epidemiology Unit, Liver Research Center, Basovizza, Trieste, Italy;1. Division of Pediatric Infectious Diseases, University of Louisville School of Medicine, Louisville, KY, USA;2. Clinical Development, Seqirus Pty Ltd, Parkville, Victoria, Australia;3. Global Pharmacovigilance and Risk Management, Seqirus Pty Ltd, Parkville, Victoria, Australia;4. Clinical Development, Seqirus Netherlands B.V., Amsterdam, The Netherlands;5. Clinical Development, Seqirus USA Inc., Cambridge, MA, USA |
| Abstract: | AimThe aim of this study was to determine the immunogenicity and reactogenicity of HPV vaccine in immunocompromised children.MethodsA multi-centre clinical trial was conducted in three paediatric hospitals in Australia. Unvaccinated children 5–18 years of age attending one of three paediatric hospitals with a range of specified conditions associated with immunosuppression were included. Quadrivalent HPV vaccine (Gardasil) was given to the participants and serum anti-HPV antibody levels were measured at baseline (before first dose), 7 and 24 months after the first dose of vaccine.ResultsFifty-nine participants were enrolled across the three paediatric hospitals and among those one was seropositive to types 6, 11 and 16 at baseline. Seven months after the first dose, seroconversion rates were 93.3%, 100%, 100% and 88.9% for type 6, 11, 16 and 18 respectively. The corresponding rates at 24 month follow up were 82.2%, 91.1%, 91.1% and 68.9%. The greatest increase in geometric mean titre (GMT) was for type 16, followed by type 11. GMTs declined over the following months, but remained more than fourfold higher for all serotypes compared to baseline titres at 24 months post vaccination. Injection site erythema, pain and swelling were commonly reported local adverse events and were less common after each dose. Few participants reported systemic adverse events, and minor disease flare occurred in two participants. One child developed a squamous cell oral carcinoma during follow up, but tissue was unable to be tested for HPV.ConclusionImmunosuppressed children had an adequate immunogenic response to Quadrivalent HPV vaccine regardless of age and the cause of immunosuppression. HPV related cancers occur at higher frequency and earlier in immunosuppressed patients, so early vaccination and optimal scheduling should be further studied in such children.Clinical trial registration: NCT02263703 (ClinicalTrials.gov) |
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