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Background Compared with the general population, the immune response to COVID-19 mRNA vaccines is lower in adult kidney transplant recipients (KTRs). However, data is limited for pediatric KTRs. In this study, we aimed to assess humoral and cellular immune responses to the COVID-19 mRNA vaccine in pediatric KTRs. Methods This multicenter, prospective, case-control study included 63 KTRs (37 male, aged 12-21 years), 19 dialysis patients, and 19 controls. Humoral (anti-SARS-CoV2 IgG, neutralizing Ab (nAb)) and cellular (interferon-gamma release assay (IGRA)) immune responses were assessed at least one month after two doses of BNT162b2 mRNA vaccine. Results Among COVID-19 naïve KTRs (n = 46), 76.1% tested positive for anti-SARS-CoV-2 IgG, 54.3% for nAb, and 63% for IGRA. Serum levels of anti-SARS-CoV-2 IgG and nAb activity were significantly lower in KTRs compared to dialysis and control groups (p < 0.05 for all). Seropositivity in KTRs was independently associated with shorter transplant duration (p = 0.005), and higher eGFR (p = 0.007). IGRA titer was significantly lower than dialysis patients (p = 0.009). Twenty (43.4%) KTRs were positive for all immune parameters. Only four of 11 seronegative KTRs were IGRA-positive. COVID-19 recovered KTRs had significantly higher anti-SARS-CoV-2 IgG and nAb activity levels than COVID-19 naïve KTRs (p = 0.018 and p = 0.007, respectively). Conclusions The humoral and cellular immune responses to SARS-CoV-2 mRNA BNT162b2 vaccine are lower in pediatric KTRs compared to dialysis patients. Further prospective studies are required to demonstrate the clinical efficacy of the mRNA vaccine in KTRs. This prospective study was registered in ClinicalTrials.gov (NCT05465863, registered retrospectively at 20.07.2022). Graphical abstract, Author(s): Ruveyda Gulmez [sup.1] , Dogukan Ozbey [sup.2] , Ayse Agbas [sup.1] , Bagdagul Aksu [sup.3] [sup.4] , Nurdan Yildiz [sup.5] , Diana Uckardes [sup.6] , Seha Saygili [sup.1] , [...]

Objective: To evaluate both humoral and cellular immune responses to the COVID-19 messenger RNA (mRNA; BNT162b2) vaccine in patients with childhood-onset SLE (cSLE) compared with healthy controls and patient controls (kidney transplant (KTx) recipients)., Methods: This single-centre, cross-sectional and case-control study included 16 patients with cSLE, 19 healthy controls and 19 KTx recipients. We assessed SARS-CoV-2-specific humoral (anti-SARS-CoV-2 IgG, neutralising antibody (nAb)) and cellular (interferon gamma release assay (IGRA)) immune responses at least 1 month after administration of two doses of the mRNA vaccine., Results: Humoral immune response rates (anti-SARS-CoV-2 IgG and nAb seropositivity) in patients with cSLE were comparable to healthy controls (100% vs 100% and 100% vs 95%, respectively) but significantly higher than in KTx recipients (74% and 42%, p<0.05 for both). Cellular immune response rate measured by IGRA was lower in patients with cSLE compared with healthy controls (56.3% vs 89.5%, p=0.050) and comparable to KTx recipients (63%). IGRA-negative patients with cSLE had significantly lower total leucocyte and lymphocyte counts at vaccination time as compared with their counterparts (p=0.008 and p=0.001, respectively). No differences were found in disease activity or immunosuppressive therapies between IGRA-negative and IGRA-positive patients with cSLE., Conclusion: Patients with cSLE showed robust humoral but compromised cellular immune responses to the COVID-19 mRNA vaccine, associated with lower lymphocyte counts. These findings highlight the need for further research to enhance vaccine efficacy in this vulnerable group., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)