TY - JOUR
T1 - Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis
T2 - a real-world multicentre study
AU - Grein, Ingrid Herta Rotstein
AU - Pinto, Natalia Balera Ferreira
AU - Groot, Noortje
AU - Martins, Camila Bertini
AU - Lobo, Aline
AU - Aikawa, Nadia Emi
AU - Barbosa, Cassia
AU - Terreri, Maria Teresa
AU - da Fraga, Aline Coelho Moreira
AU - de Oliveira, Sheila Knupp Feitosa
AU - Sztajnbok, Flavio
AU - Paim Marques, Luciana B
AU - Islabão, Aline Garcia
AU - Appenzeller, Simone
AU - Bica, Blanca
AU - de Oliveira Sato, Juliana
AU - Magalhães, Claudia Saad
AU - Ferriani, Virgínia
AU - Pasmans, Hella
AU - Schepp, Rutger
AU - van der Klis, Fiona
AU - de Roock, Sytze
AU - Wulffraat, Nico
AU - Pileggi, Gecilmara Salviato
N1 - Funding Information:
We appreciate the collaboration of those who also made it possible to successfully complete this research project. Among them, the Brazilian National Immunization Program, for the donation of the quadrivalent HPV vaccine; GlaxoSmithKline, for the donation of the virus-like particle for multiplex technology Luminex assay; the collaborators of the Special Immunobiological Reference Center of the Hospital das Clínicas de Ribeirão Preto; the collaborators of the Childcare and Pediatrics Laboratory of the Ribeirão Preto Medical School, and all the team that worked at the Brazilian centres in order to recruit the participants of this study.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/11/11
Y1 - 2020/11/11
N2 - 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.RESULTS: The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types.CONCLUSIONS: The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients.TRIAL REGISTRATION: Brazilian Clinical Trials Registry, number: RBR-9ypbtf . Registered 20 March 2018 - Retrospectively registered.
AB - 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.RESULTS: The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types.CONCLUSIONS: The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients.TRIAL REGISTRATION: Brazilian Clinical Trials Registry, number: RBR-9ypbtf . Registered 20 March 2018 - Retrospectively registered.
KW - Immunogenicity
KW - Juvenile dermatomyositis
KW - Quadrivalent HPV vaccine
KW - Safety
UR - https://www.scopus.com/pages/publications/85095814677
U2 - 10.1186/s12969-020-00479-w
DO - 10.1186/s12969-020-00479-w
M3 - Article
C2 - 33176806
SN - 1546-0096
VL - 18
SP - 1
EP - 12
JO - Pediatric rheumatology online journal
JF - Pediatric rheumatology online journal
IS - 1
M1 - 87
ER -