Agarwal Anurag, Singh Charu, Mathur Surendra Bahadur, Manchanda Vikas, Agarwal Kashvi, Mantan Mukta, Khan Amir Maroof
Department of Pediatrics, Maulana Azad Medical College & Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi, 110002, India.
Department of Pediatrics, Postgraduate Institute of Child Health, Sector- 30, Gautam Buddha Nagar, Noida, 201303, Uttar Pradesh, India.
Infection. 2025 Aug 8. doi: 10.1007/s15010-025-02623-8.
Rabies is a fatal zoonotic disease, and India accounts for 35% of global rabies-related deaths. In 2018, the World Health Organization (WHO) revised its guidelines for pre-exposure prophylaxis (PrEP) from a 3-dose to a cost-saving 2-dose intradermal (ID) regimen. This study evaluates the immunogenicity and safety of this regimen in pediatric populations, including children exposed to immunosuppressant therapy.
This single-center, prospective, comparative follow-up study was conducted at a tertiary care hospital. Participants (5-18 years) were enrolled into two groups: (1) children with no known immunodeficiency (n = 31) and (2) children on immunosuppressant therapy (n = 10). All received Vero cell culture rabies vaccine (RABIVAX-S) intradermally at two sites on days 0 and 7. Serum anti-rabies virus glycoprotein antibody titres were assessed on days 28, 90, and 180 using an ELISA-based assay. Booster doses were administered to those with insufficient titers (≤ 0.5 EU/ml).
By day 28, both groups achieved a 100% seroconversion rate (SCR). Geometric mean titers (GMT) were 2.168 EU/ml and 1.547 EU/ml in the no-known-immunodeficiency and immunosuppressant therapy groups, respectively. At day 90, SCRs were 90% and 70%, with GMTs of 1.358 EU/ml and 0.962 EU/ml, respectively. Booster doses restored titers in all participants with insufficient levels. Pain at the injection site was the only solicited adverse effect.
The 2-dose ID PrEP regimen is immunogenic and safe in pediatric populations, including immunosuppressed children. It offers a cost-effective alternative in rabies-endemic regions, enhancing compliance and accessibility.
Prospectively registered with the Clinical Trials Registry India with Trial Registration No. CTRI/2022/10/046777.
狂犬病是一种致命的人畜共患病，印度占全球狂犬病相关死亡人数的35%。2018年，世界卫生组织（WHO）将其暴露前预防（PrEP）指南从3剂改为成本节约型的2剂皮内（ID）方案。本研究评估了该方案在儿科人群中的免疫原性和安全性，包括接受免疫抑制治疗的儿童。
本单中心、前瞻性、对比随访研究在一家三级护理医院进行。参与者（5 - 18岁）被分为两组：（1）无已知免疫缺陷的儿童（n = 31）和（2）接受免疫抑制治疗的儿童（n = 10）。所有参与者均在第0天和第7天在两个部位皮内注射Vero细胞培养狂犬病疫苗（RABIVAX - S）。在第28天、90天和180天使用基于酶联免疫吸附测定（ELISA）的方法评估血清抗狂犬病病毒糖蛋白抗体滴度。对滴度不足（≤0.5 EU/ml）的参与者给予加强剂量。
到第28天，两组的血清转化率（SCR）均达到100%。在无已知免疫缺陷组和免疫抑制治疗组中，几何平均滴度（GMT）分别为2.168 EU/ml和1.547 EU/ml。在第90天，SCR分别为90%和70%，GMT分别为1.358 EU/ml和0.962 EU/ml。加强剂量使所有滴度不足的参与者的滴度恢复。注射部位疼痛是唯一报告的不良反应。
2剂ID PrEP方案在儿科人群中具有免疫原性且安全，包括免疫抑制儿童。它在狂犬病流行地区提供了一种具有成本效益的替代方案，提高了依从性和可及性。
在印度临床试验注册中心进行前瞻性注册，试验注册号为CTRI/2022/10/046777。
