Vadrevu Krishna Mohan, Chiteti Siddharth Reddy, Dugyala Raju, Aileni Vinay Kumar, Kunta Akhila, Patnaik Badri Narayan, Ella Raches
Bharat Biotech International Ltd, Hyderabad, India.
Hum Vaccin Immunother. 2025 Dec;21(1):2507912. doi: 10.1080/21645515.2025.2507912. Epub 2025 May 30.
Typhoid fever is a significant health concern in low- and middle-income countries, with millions of cases and thousands of deaths each year. Typhoid Conjugate Vaccines, such as Typbar TCV®, have been developed to provide longer-lasting protection for young children. This publication includes the readouts from two different studies in Children and elderly: a Comparator Study and Age Extension Study. In the first study, children are included, whereas the latter study also includes elderly subjects. A total of 340 children were enrolled, and a subset received a booster dose of Typbar TCV®, 180 days later. Results established that Typbar TCV® induced significantly higher antibody titer compared to Typhim Vi on days 28 and 90 ( < .001). No significant differences in adverse events were found between the two vaccine arms. Overall, Typbar TCV® was well tolerated, inducing higher anti-Vi-IgG titers than Typhim Vi®, with sustained response over the study period. The booster dose post-6 months in the Typbar TCV® group was significantly less immunogenic compared to a booster at 2 years ( < .001), suggesting a delayed booster might enhance the anamnestic response, a fact confirmed in our previous clinical studies of Typbar TCV®. In the Age Extension study, 300 healthy volunteers, including younger (18-65) and elderly adults (65 and older), received a single dose of Typbar TCV®. The vaccine is reported to be safe and induced similar anti Vi-Ab geometric mean titers (GMTs) in young and elderly adults. Thus, Typbar TCV® was studied effectively from 6 months to above 85 years, which is the upper age limit. CTRI Registration number: CTRI/2016/01/006476, CTRI/2024/06/069638.
伤寒热在低收入和中等收入国家是一个重大的健康问题，每年有数百万病例和数千人死亡。已研发出伤寒结合疫苗，如Typbar TCV®，为幼儿提供更持久的保护。本出版物包括两项针对儿童和老年人的不同研究的结果：一项对照研究和年龄扩展研究。第一项研究纳入了儿童，而第二项研究还纳入了老年受试者。总共招募了340名儿童，其中一部分在180天后接受了Typbar TCV®的加强剂量。结果表明，在第28天和第90天，与Typhim Vi相比，Typbar TCV®诱导的抗体滴度显著更高（<0.001）。在两个疫苗组之间未发现不良事件有显著差异。总体而言，Typbar TCV®耐受性良好，诱导的抗Vi-IgG滴度高于Typhim Vi®，且在研究期间反应持续。与2年时的加强剂量相比，Typbar TCV®组6个月后的加强剂量免疫原性显著较低（<0.001），这表明延迟加强剂量可能会增强回忆反应，这一事实在我们之前关于Typbar TCV® 的临床研究中得到了证实。在年龄扩展研究中，300名健康志愿者，包括年轻人（18 - 65岁）和老年人（65岁及以上），接受了单剂量的Typbar TCV®。据报道，该疫苗是安全的，并且在年轻人和老年人中诱导出相似的抗Vi抗体几何平均滴度（GMTs）。因此，对Typbar TCV®进行了从6个月到85岁以上（年龄上限）的有效研究。CTRI注册号：CTRI/2016/01/006476，CTRI/2024/06/069638。
