Hamad Saied Mohamad, El Bied Noehaila, Khoury Lana, Vastert Sebastiaan J, Swart Joost, van Royen Annet, van Nieuwenhove Erika, Wolters Victorien M, van Montfrans Joris, Lunel Frans Verduyn, de Roock Sytze, Jansen Marc
Department of Paediatric Immunology and Rheumatology, Wilhelmina Children's Hospital/ University Medical Center Utrecht, Utrecht, the Netherlands; Department of Pediatrics, Carmel Medical Center, Technion Faculty of Medicine, Haifa, Israel.
Department of Paediatric Immunology and Rheumatology, Wilhelmina Children's Hospital/ University Medical Center Utrecht, Utrecht, the Netherlands.
Vaccine. 2025 Oct 3;64:127708. doi: 10.1016/j.vaccine.2025.127708. Epub 2025 Sep 6.
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.
To evaluate the safety, immunogenicity, and efficacy of the Shingrix vaccine administered to VZV-naïve pediatric patients receiving immunosuppressive therapy.
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.
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.
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.
患有自身免疫性和炎性疾病的儿科患者通常需要免疫抑制治疗，这会增加他们对包括水痘带状疱疹病毒（VZV）在内的感染的易感性。虽然减毒活水痘疫苗在大多数免疫功能低下的儿童中是禁忌的，但重组亚单位疫苗欣安立适（Shingrix）可能提供一种替代预防策略。然而，关于其在未感染过VZV的儿科患者中的安全性、免疫原性和有效性的数据仍然有限。
评估向接受免疫抑制治疗的未感染过VZV的儿科患者接种欣安立适疫苗的安全性、免疫原性和有效性。
我们在荷兰威廉明娜儿童医院儿科风湿病科进行了一项单中心、真实世界回顾性队列研究。纳入了10名接受免疫抑制治疗且未感染过VZV的儿科患者（中位年龄：2岁11个月），他们接种了欣安立适疫苗。根据接种疫苗后三个月内记录的不良事件评估安全性。通过测量接种疫苗前后的VZV IgG抗体水平评估免疫原性。通过突破性水痘感染的发生情况和临床严重程度确定有效性。从首次接种欣安立适疫苗到数据收集的中位随访期为7.6个月。
10名患者中有9名在接种疫苗后产生了VZV特异性IgG抗体。仅接种一剂的一名患者仍为血清阴性。观察到两例轻度突破性水痘感染，无并发症。记录到一例严重不良事件，可能归因于并发病毒感染而非疫苗本身。
据我们所知，这是关于在未感染过VZV、免疫功能低下的儿科患者中使用欣安立适的首次报告。欣安立适在免疫功能低下的儿科患者中显示出可接受的安全性，除一例患者外，在所有病例中均引发了体液免疫反应。尽管观察到轻度突破性感染，但该疫苗似乎提供了针对水痘的保护。有必要进行更大队列和更长随访时间的前瞻性研究，以确认其在这一脆弱人群中的长期疗效和最佳接种策略。
