Ingrid Herta Rotstein Grein1,2, Natalia Ferreira Pinto3, Aline Lobo3, Noortje Groot1, Flavio Sztajnbok4, Clóvis Artur Almeida da Silva5, Luciana B Paim Marques6,7, Simone Appenzeller8, Aline Garcia Islabão9, Claudia Saad Magalhães10, Rozana Gasparello de Almeida11, Blanca Bica12, Melissa Fraga13, Aline Coelho Moreira da Fraga14, Maria Carolina Dos Santos15, Teresa Robazzi16, Maria Teresa Ra Terreri17, Marcia Bandeira18, Hella Pasmans19, Rutger Schepp19, Fiona van der Klis19, Sytze de Roock1, Nico Wulffraat1, Gecilmara Pileggi20. 1. Department of Paediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands. 2. Department of Paediatrics, Hospital de Clinicas, Universidade Federal do Paraná, Curitiba, Brazil. 3. Department of Paediatrics, Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo, São Paulo, Brazil. 4. Department of Paediatric Rheumatology, Universidade Estadual do Rio de Janeiro, Rio de Janeiro, Brazil. 5. Department of Paediatric Rheumatology, Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. 6. Department of Paediatric Rheumatology, Hospital Infantil Albert Sabin, Fortaleza, Brazil. 7. Department of Paediatric Immunology and Rheumatology, University of Florida College of Medicine, Florida, USA. 8. Department of Paediatric Rheumatology, Universidade Estadual de Campinas, São Paulo, Brazil. 9. Department of Paediatric Rheumatology, Hospital da Criança de Brasília José Alencar, Brasília, Brazil. 10. Department of Paediatric Rheumatology, Universidade Estadual Paulista, Botucatu, São Paulo, Brazil. 11. Department of Paediatric Rheumatology, Instituto de Puericultura e Pediatria Martagão Gesteira (IPPMG), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil. 12. Department of Paediatric Rheumatology, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil. 13. Department of Paediatric Rheumatology, Hospital Infantil Darcy Vargas, São Paulo, Brazil. 14. Department of Paediatric Rheumatology, Hospital Estadual Infantil Nossa Senhora da Glória, Vitória, Brazil. 15. Department of Paediatric Rheumatology, Santa Casa de São Paulo, São Paulo, Brazil. 16. Department of Paediatric Rheumatology, Faculdade de Medicina da Universidade Federal da Bahia, Salvador, Brazil. 17. Department of Paediatric Rheumatology, Universidade Federal de São Paulo, São Paulo, Brazil. 18. Department of Paediatric Rheumatology, Hospital Pequeno Príncipe, Curitiba, Brazil. 19. Centre for Infectious Disease Control, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands. 20. Department of Paediatric Rheumatology, Faculdade de Medicina Barretos (FACISB), Barretos, Brazil.
Abstract
OBJECTIVE: This study aimed to assess the safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccination in childhood-onset systemic lupus erythematosus (cSLE) patients. METHODS: Volunteer cSLE patients aged 9-20 years and healthy controls (HC) were enrolled to receive a two- or three-dose qHPV vaccination schedule from March 2014 to March 2016. Study visits were performed before the first dose, one month after the second and third doses and one year after the first dose. In each study visit, disease activity and adverse events following vaccination were analyzed, and a serum sample was collected for testing antibody concentrations. Participant recruitment was conducted in 15 Brazilian paediatric rheumatology units. Of the 256 cSLE patients included, 210 completed the two- or three-dose schedules; 15 had previously received one dose, and 18 had received two doses of the vaccine. The analysis was based on intention-to-treat so that participants who did not complete the entire study protocol were also included. RESULTS: No severe adverse events were related to the vaccination. Disease activity was generally low and remained stable or even improved. The HC presented 100% seropositivity to HPV16 and HPV18, whereas the two- and three-dose cSLE groups presented 93% and 83% versus 97% and 91%, respectively. One year after the first dose, seropositivity of the three-dose cSLE group was 91% to HPV16 and 84% to HPV18. CONCLUSIONS: HPV vaccination in cSLE patients is safe and immunogenic. Since the seropositivity to HPV16 and HPV18 was higher for the three-dose schedule group, this regimen should be recommended for cSLE patients.
OBJECTIVE: This study aimed to assess the safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccination in childhood-onset systemic lupus erythematosus (cSLE) patients. METHODS: Volunteer cSLE patients aged 9-20 years and healthy controls (HC) were enrolled to receive a two- or three-dose qHPV vaccination schedule from March 2014 to March 2016. Study visits were performed before the first dose, one month after the second and third doses and one year after the first dose. In each study visit, disease activity and adverse events following vaccination were analyzed, and a serum sample was collected for testing antibody concentrations. Participant recruitment was conducted in 15 Brazilian paediatric rheumatology units. Of the 256 cSLE patients included, 210 completed the two- or three-dose schedules; 15 had previously received one dose, and 18 had received two doses of the vaccine. The analysis was based on intention-to-treat so that participants who did not complete the entire study protocol were also included. RESULTS: No severe adverse events were related to the vaccination. Disease activity was generally low and remained stable or even improved. The HC presented 100% seropositivity to HPV16 and HPV18, whereas the two- and three-dose cSLE groups presented 93% and 83% versus 97% and 91%, respectively. One year after the first dose, seropositivity of the three-dose cSLE group was 91% to HPV16 and 84% to HPV18. CONCLUSIONS: HPV vaccination in cSLE patients is safe and immunogenic. Since the seropositivity to HPV16 and HPV18 was higher for the three-dose schedule group, this regimen should be recommended for cSLE patients.