Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with childhood systemic lupus erythematosus: a real-world interventional multi-centre study

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.

Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study

“…The combined analysis of mild AEFV (similar to the HC group) and stable disease activity throughout the study showed that the 3-dose scheme of qHPV vaccine was safe in this JDM cohort. Our results are in accordance with other studies that showed no influence of HPV vaccines regarding AEFV and disease activity in patients with AID [8,29,30,[42][43][44][45].…”

“…This result was surprisingly good, as it is generally accepted that patients using immunosuppressive drugs, especially at high doses, present a diminished response to vaccinations [3,5,6]. Our results are in accordance with other studies addressing HPV vaccinations in patients with AID [42][43][44][45]. In those studies, HPV-vaccination induced seroconversion in the large majority of patients.…”

An Update on the Management of Childhood-Onset Systemic Lupus Erythematosus

“…Therefore, immunization is a powerful tool to reduce the burden of infectious diseases in the clinical management of cSLE and is recommended to be undertaken prior to the initiation of immunosuppressive treatment for all patients. Routine non-live vaccinations are strongly suggested for all children and adolescents with cSLE, such as influenza, tetanus, hepatitis A and B, meningococcal, pneumococcal, quadrivalent human papillomavirus vaccinations, and COVID-19 [115,116]. Live attenuated immunizations (such as varicella-zoster; measles, mumps and rubella; and yellow fever vaccines) are generally not indicated for immunosuppressed cSLE patients [2]; however, no severe events with live-attenuated viruses were reported in a case series of vaccinated cSLE patients under immunosuppressive agents, after the measles, mumps and rubella and varicella-zoster booster vaccinations [117].…”

01 Should we vaccinate all SLE patients against papillomavirus and herpes zoster?

“…A study of 210 patients with SLE, HPV vaccine was found to be immunogenic in~90% of patients with no serious side effects or increased lupus flare at oneyear follow-up. 4 The use of cyclophosphamide was associated with low rates of HPV seroconversion. The live-attenuated HZ vaccine was also found to be safe and immunogenic with no increase in incidence of herpes zoster in patients with SLE on milder immunosuppressants.…”

“…Clinical, serologic, imaging and biopsy features of this complication will be described in 8 patients recently seen in the University of Toronto Lupus Clinic. 4 A systematic review of 47 patients with biopsy proven AMIC will be presented. 5 Features of AMIC include morphologic/structural changes (biventricular/ septal hypertrophy, bi-atrial enlargement); functional defects (impaired systolic and diastolic function); conduction disorders (RBBB, LAFB, cAVB/SSS); elevated biomarkers (troponins [cTnI], BNP, CPK).…”