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This prospective study investigated the immunogenicity and safety of the inactivated hepatitis A vaccine in pediatrics with autoinflammatory diseases receiving biologic treatments—specifically, canakinumab and tocilizumab.
All vaccinated children with autoinflammatory diseases on canakinumab or tocilizumab develop protective anti-HAV IgG without any observed adverse effects, despite lower antibody titers.
This prospective study investigated the immunogenicity and safety of the inactivated hepatitis A vaccine in pediatrics with autoinflammatory diseases receiving biologic treatments—specifically, canakinumab and tocilizumab.
The study enrolled 24 patients diagnosed with autoinflammatory diseases and undergoing treatment with canakinumab or tocilizumab, along with 39 healthy children, all of whom were seronegative for hepatitis A. Participants received two doses of the inactivated hepatitis A vaccine administered 6 months apart. Notably, 1 month after the second dose, venous blood samples were collected to measure anti-hepatitis A virus (anti-HAV) IgM and IgG titers.
In this observational controlled study, the patient cohort included 19 individuals with systemic juvenile idiopathic arthritis (sJIA) and 5 with cryopyrin-associated periodic syndrome (CAPS). The mean age was 14.1 ± 3.7 years in the patient group and 12.4 ± 3.2 years in the control group. All CAPS patients and 52.6% (10/19) of those with sJIA were receiving canakinumab, while the remaining 9 sJIA patients (47.3%) were treated with tocilizumab. Additionally, 15 sJIA patients were on methotrexate and 14 on prednisolone.
In all the enrolled subjects, the baseline hepatitis A serology was negative. After full vaccination, seroconversion (anti-HAV IgG positivity) was achieved in 100% of the patient group and 84.6% (33/39) of the healthy controls (p = 0.04). Mean anti-HAV IgG titers were markedly lower in the patients when compared to controls (5.25 ± 1.49 IU/L vs. 10.5 ± 7.02 IU/L; p < 0.001). During the follow-up period, no vaccine-related adverse events or disease exacerbations were noted.
The inactivated hepatitis A vaccine appears to be both immunogenic and well-tolerated in children with autoinflammatory diseases receiving biologic therapies. Larger, long-term studies are warranted to substantiate its safety profile in this patient cohort.
International Journal of Rheumatic Diseases
The Efficacy and Safety of Hepatitis A Vaccine in Children and Young Adults With an Autoinflammatory Diseases on Canakinumab and Tocilizumab Treatments: A Prospective Observational Controlled Study
Kenan Barut et al.
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