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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.
Univ Med Ctr Utrecht, Wilhelmina Childrens Hosp, Dept Paediat Immunol & Rheumatol, Utrecht, Netherlands
Univ Fed Parana, Hosp Clin, Dept Paediat, Curitiba, Parana, Brazil
Univ Sao Paulo, Dept Paediat, Fac Med Ribeirao Preto, Sao Paulo, Brazil
Univ Estado Rio De Janeiro, Dept Paediat Rheumatol, Rio De Janeiro, Brazil
Univ Sao Paulo, Hosp Clin, Inst Crianca, Dept Paediat Rheumatol,Fac Med, Sao Paulo, Brazil
Hosp Infantil Albert Sabin, Dept Paediat Rheumatol, Fortaleza, Ceara, Brazil
Univ Florida, Coll Med, Dept Paediat Immunol & Rheumatol, Gainesville, FL USA
Univ Estadual Campinas, Dept Paediat Rheumatol, Sao Paulo, Brazil
Hosp Crianca Brasilia Jose Alencar, Dept Paediat Rheumatol, Brasilia, DF, Brazil
Univ Estadual Paulista, Dept Paediat Rheumatol, Botucatu, SP, Brazil
Univ Fed Rio de Janeiro, Inst Puericultura & Pediat Martagao Gesteira IPPM, Dept Paediat Rheumatol, Rio De Janeiro, Brazil
Univ Fed Rio de Janeiro, Dept Paediat Rheumatol, Rio De Janeiro, Brazil
Hosp Infantil Darcy Vargas, Dept Paediat Rheumatol, Sao Paulo, Brazil
Hosp Estadual Infantil Nossa Senhora da Gloria, Dept Paediat Rheumatol, Vitoria, ES, Brazil
Santa Casa Sao Paulo, Dept Paediat Rheumatol, Sao Paulo, Brazil
Univ Fed Bahia, Dept Paediat Rheumatol, Fac Med, Salvador, BA, Brazil
Univ Fed Sao Paulo, Dept Paediat Rheumatol, Sao Paulo, Brazil
Hosp Pequeno Principe, Dept Paediat Rheumatol, Curitiba, Parana, Brazil
Natl Inst Publ Hlth & Environm RIVM, Ctr Infect Dis Control, Bilthoven, Netherlands
Fac Med Barretos FACISB, Dept Paediat Rheumatol, Barretos, Brazil
Univ Estadual Paulista, Dept Paediat Rheumatol, Botucatu, SP, Brazil
