Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a
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RESEARCH ARTICLE
Open Access
Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study Ingrid Herta Rotstein Grein1,2* , Natalia Balera Ferreira Pinto3, Noortje Groot1, Camila Bertini Martins4, Aline Lobo3, Nadia Emi Aikawa5, Cassia Barbosa6, Maria Teresa Terreri6, Aline Coelho Moreira da Fraga7, Sheila Knupp Feitosa de Oliveira8, Flavio Sztajnbok9, Luciana B. Paim Marques10,11, Aline Garcia Islabão12, Simone Appenzeller13, Blanca Bica14, Juliana de Oliveira Sato15, Claudia Saad Magalhães15, Virgínia Ferriani16, Hella Pasmans17, Rutger Schepp17, Fiona van der Klis17, Sytze de Roock1, Nico Wulffraat1 and Gecilmara Salviato Pileggi18
Abstract Background: Concerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients. Methods: JDM patients aged from 9 to 20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, 1 month after the second and third doses, and 6 months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study. (Continued on next page)
* Correspondence: [email protected] 1 Department of Paediatric Immunology and Rheumatology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands 2 Department of Paediatrics, Hospital de Clínicas da Universidade Federal do Paraná, General Carneiro Street 68, 181, Alto da Gloria, Curitiba, PR 80060-900, Brazil Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or
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