Safety and immunogenicity of human papillomavirus vaccination in juvenile patients with rheumatic diseases

Methods A prospective controlled observational trial was initiated in female patients and healthy controls aged 12-18 years. Patients and controls were vaccinated (0, 1, and 6 months) and followed for 12 months. HPV16 and 18specific antibody concentrations were measured using a fluorescent microspheres-based multiplex immuno-assay after 12 months. Adverse events (AE’s) 2 weeks after each vaccination were systematically documented in diaries. In patients, medication use was monitored and disease activity was measured by the Juvenile Arthritis Disease Activity Score of 27 joints (JADAS-27), SLE Disease Activity Index, or the Childhood Myositis Assessment Scale.