Department of Paediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Infection, Immunity and Global Health, Murdoch Children's Research Institute, Parkville, VIC, Australia.
Lupus. 2024 Apr;33(5):450-461. doi: 10.1177/09612033241232576. Epub 2024 Feb 9.
We evaluated the immunogenicity and safety of BNT162b2 vaccination in adolescents with systemic lupus erythematosus (adoSLE) receiving either high- or low-dose immunosuppressant (High-IS and Low-IS).
Patients aged 12-18 years diagnosed with SLE were enrolled. High-IS was defined as >7.5 mg/day prednisolone or with other immunosuppressant, while Low-IS was defined as only ≤7.5 mg/day of prednisolone and no immunosuppressant. Two doses of BNT162b2 vaccination were given 4 weeks apart, followed by a booster (third) dose at 4-6 months later. Anti-spike receptor binding domain (anti-RBD) IgG against Wuhan, neutralising antibody (NT) against Wuhan and Omicron variants, and cellular immune response by IFN-γ-ELISpot assay were evaluated following vaccination. Adverse events (AEs) and SLE flare were monitored.
A total of 73 participants were enrolled, 40 and 33 in the High-IS and Low-IS group, respectively. At 4 weeks following the 2nd dose, overall anti-RBD IgG seropositivity was 97.3%, with no difference between the groups ( = .498). AdoSLE on High-IS had lower anti-RBD IgG ( < .001), Wuhan NT ( < .001), and IFN-γ-ELISpot ( = .022) than those on Low-IS. A 3rd dose induced significantly higher antibody responses than after the 2nd dose ( < .001) in both groups and established seroconversion against Omicron variants, with persistent lower antibody levels in High-IS group. SELENA-SLEDAI scores within 12 weeks after 2-dose vaccination was higher than before vaccination (3.1 vs 2.5; < .036); however, the occurrence of disease flare by SELENA-SLEDAI flare index was not different after vaccination compared to before vaccination, consistent across groups. Non-severe AEs occurred similarly in both groups.
AdoSLE on High-IS induced lower SARS-CoV-2 vaccine immune responses than Low-IS. Vaccination can increase disease activity and requires close monitoring for disease flare.
我们评估了接受高剂量或低剂量免疫抑制剂（高 IS 和低 IS）的系统性红斑狼疮（adoSLE）青少年接种 BNT162b2 疫苗的免疫原性和安全性。
招募了年龄在 12-18 岁、诊断为 SLE 的患者。高 IS 定义为 >7.5mg/天泼尼松龙或使用其他免疫抑制剂，而低 IS 定义为仅 ≤7.5mg/天泼尼松龙且无免疫抑制剂。两剂 BNT162b2 疫苗间隔 4 周接种，然后在 4-6 个月后进行加强（第三剂）。接种后评估针对武汉、中和抗体（NT）针对武汉和奥密克戎变异株的 Spike 受体结合域（anti-RBD）IgG 以及通过 IFN-γ-ELISpot 测定的细胞免疫反应。监测不良事件（AE）和 SLE 发作。
共纳入 73 名参与者，高 IS 组和低 IS 组分别为 40 名和 33 名。第 2 剂接种后 4 周，总 anti-RBD IgG 血清阳性率为 97.3%，两组间无差异（=0.498）。高 IS 组的 adoSLE 患者的 anti-RBD IgG（<0.001）、武汉 NT（<0.001）和 IFN-γ-ELISpot（=0.022）均低于低 IS 组。两组在第 2 剂和第 3 剂接种后均诱导了显著更高的抗体反应（<0.001），并建立了针对奥密克戎变异株的血清转换，但高 IS 组的抗体水平持续较低。第 2 剂接种后 12 周内的 SELENA-SLEDAI 评分高于接种前（3.1 与 2.5；<0.036）；然而，与接种前相比，接种后通过 SELENA-SLEDAI 发作指数发生疾病发作的情况并无不同，各组之间一致。两组的非严重 AE 发生率相似。
高 IS 组的 adoSLE 诱导的 SARS-CoV-2 疫苗免疫反应低于低 IS 组。接种疫苗会增加疾病活动度，需要密切监测疾病发作。
