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DOI 10.1080/21645515.2025.2507912

Медицинская библиотека · Human vaccines & immunotherapeutics · 2025

Comparative immune response of Typbar TCV® (typhoid conjugate vaccine) in extremes of age: An Indian experience.

Vadrevu Krishna Mohan, Chiteti Siddharth Reddy, Dugyala Raju, Aileni Vinay Kumar, Kunta Akhila, Patnaik Badri Narayan, Ella Raches

Клиническое исследование III фазыКлиническое исследование IV фазыСравнительное исследованиеEquivalence TrialСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

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 (p < .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 (p < .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.

Для цитирования: Vadrevu Krishna Mohan, Chiteti Siddharth Reddy, Dugyala Raju, Aileni Vinay Kumar, Kunta Akhila, Patnaik Badri Narayan, Ella Raches. Comparative immune response of Typbar TCV® (typhoid conjugate vaccine) in extremes of age: An Indian experience.. Human vaccines & immunotherapeutics. 2025. DOI: 10.1080/21645515.2025.2507912.

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