Safety, immunogenicity and efficacy of the Shingrix vaccine in immunocompromised varicella zoster virus naïve pediatric patients

Abstract

BACKGROUND: Pediatric patients with autoimmune and inflammatory diseases often require immunosuppressive therapy, which increases their susceptibility to infections, including varicella-zoster virus (VZV). While the live attenuated varicella vaccine is contraindicated in most immunocompromised children, the recombinant subunit vaccine, Shingrix, may offer an alternative preventive strategy. However, data on its safety, immunogenicity, and efficacy in pediatric VZV-naïve patients remain limited. OBJECTIVE: To evaluate the safety, immunogenicity, and efficacy of the Shingrix vaccine administered to VZV-naïve pediatric patients receiving immunosuppressive therapy. METHODS: We conducted a monocenter, real-world retrospective cohort study at the Pediatric Rheumatology Department of Wilhelmina Children's Hospital, Netherlands. Ten VZV-naïve pediatric patients (median age: 2 years 11 months) on immunosuppressive treatment who received the Shingrix vaccine were included. Safety was evaluated based on adverse events recorded within three months post-vaccination. Immunogenicity was assessed by measuring VZV IgG antibody levels pre- and post-vaccination. Efficacy was determined by the occurrence and clinical severity of breakthrough varicella infections. The median follow-up period from the first Shingrix dose to data collection was 7.6 months. RESULTS: Nine of ten patients developed VZV-specific IgG antibodies post-vaccination. One patient who received only a single dose remained seronegative. Two mild breakthrough varicella infections were observed without complications. One severe adverse event was recorded, likely attributable to concurrent viral infection rather than the vaccine itself. CONCLUSION: To our knowledge, this is the first report on the use of Shingrix in VZV-naïve, immunocompromised pediatric patients. Shingrix demonstrated an acceptable safety profile in immunocompromised pediatric patients and elicited a humoral immune response in all but one cases. The vaccine appeared to provide protection against varicella, although mild breakthrough infections were observed. Prospective studies with larger cohorts and longer follow-ups are warranted to confirm its long-term efficacy and optimal vaccination strategies in this vulnerable population.