Juvenile Systemic Lupus Erythematosus
Conditions
Interventions
1. Administration of three doses of the quadrivalent human papillomavirus vaccine in the 0 - 2 months - 6 months schedule in 234 patients with juvenile systemic lupus erythematosus, 47 patients with j
After each vaccination dose, a diary of possible adverse events after vaccination was given, to be completed for fourteen consecutive days after vaccination, totaling 555 diaries of lupus patients, 17
Of the dermatomyositis patients, totaled 120 daily, 39 after the first dose, 41 after the second dose and 40 after the third dose
The control group totaled 115 daily, 38 after the first dose, 38 after the second dose and 35 after the third dose.
3. Evaluation of the influence of the vaccine on the activity of lupus diseases and
For this purpose, instruments that measure disease activity and the evaluation of clinical measures, only for patients with dermatomyositis, were used in 3 visits, being the initial visit which was ad
This evaluation was only for the patient groups
The instruments used were for the lupus patients: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and for the dermatomyositis patients: Childhood Myositis Activity Index (CMAS) and the cl
Biological/vaccine
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Departamento de Pediatria e Puericultura da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Eligibility
Sex/Gender
Female
Age
9 Years to 20 Years
Inclusion criteria
Inclusion criteria: Being female; Be between 9-20 years old; Have been diagnosed with one of the following immune system disorders before the age of 17 and before their first quadrivalent vaccine against human papillomavirus: juvenile systemic lupus erythematosus or juvenile dermatomyositis; Have not received the three doses of the quadrivalent human papillomavirus vaccine
Exclusion criteria
Exclusion criteria: The absence of parental consent for those under 18 or consent from the patient or control; refusal of any blood collection; hx of suspected or proven cervical carcinoma; being pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with autoimmune diseases lupus and dermatomyositis have a reduced serological immune response to human papillomavirus vaccination compared to healthy people. Immunogenicity will be measured by antibody levels against human papillomavirus serotypes 16 and 18 at study inclusion (before the first dose) and at 3.7 and 12 months after the first vaccination through the Luminex immunoassay. Patients or controls with against human papillomavirus 16 above the 9 mMU / ml cutt-off and against human papillomavirus 18 above 13 mMU / ml are considered responders.;The seropositivity of 144 lupus patients, 31 dermatomyositis patients, and 31 healthy control girls who completed the three-dose regimen and had a blood sample taken after the third dose were 95% for human papillomavirus 16 and 87% for human papillomavirus 18 of those with lupus, 100% for human papillomavirus 16 and 97% for human papillomavirus 18 of those with dermatomyositis and 100% for both human papillomavirus types of controls.;Diseases lupus and dermatomyositis do not worsen after vaccination against human papillomavirus, ie disease activity is not aggravated; lupus activity is assessed using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) instrument; the scores range from 0 to 105 points, with 0 being inactive and above 4 in activity, classified as mild, moderate, high or very high activity; dermatomyositis activity is assessed using the Childhood Myositis Assessment Scale (CMAS) instrument; this instrument ranges from 0 (high disease activity) to 52 (no disease activity) and is considered active when below 48 points; dermatomyositis activity is also assessed by heliotrope, rash and gottron skin changes; these changes are evaluated at consultations using clinical parameters and described if they are present, worsened or improved between consultations.;The median activity of the disease in lupus patients measured with the Systemic Lupus Erythematosus Disease Activity Index before the firs | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events following human papillomavirus vaccination do not show statistically significant differences between lupus and dermatomyositis patients and healthy control subjects; the monitoring of adverse events after vaccination is done through a diary of possible adverse events to be completed for 14 days.;Controls had fewer systemic adverse events compared to lupus patients; this can be explained by the fact that systemic manifestations of lupus are similar to adverse events such as muscle pain and fatigue. Compared to patients with dermatomyositis, there were no statistically significant differences; the same was observed among patients with lupus and dermatomyositis. As for local adverse events, no differences were found between any groups. | — |
Countries
Brazil
Contacts
Public ContactGecilmara Pileggi
Departamento de Pediatria e Puericultura da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed