One-month evaluation of safety and immunogenicity of a Vi-DT typhoid conjugate vaccine (Bio-TCV®) in Indonesian subjects 6 months to 45 years: A phase III randomized clinical trial

IF 2.7 Q3 IMMUNOLOGY

Vaccine: X Pub Date : 2025-05-20 DOI:10.1016/j.jvacx.2025.100661

Bernie Endyarni Medise , I. Gusti Ayu Trisna Windiani , Dominicus Husada , Rini Sekartini , Hartono Gunardi , Angga Wirahmadi , Dwiyanti Puspitasari , Leny Kartina , I. Gusti Agung Ngurah Sugitha Adnyana , I. Gusti Lanang Sidiartha , I. Made Dwi Lingga Utama , I. Ketut Agus Somia , Iris Rengganis , Sukamto Koesnoe , Hindra Irawan Satari , Soedjatmiko Soedjatmiko , Sri Rezeki Hadinegoro , Ismoedijanto Ismoedijanto , Parwati Setiono Basuki , Gatot Soegiarto , Sushant Sahastrabuddhe

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Abstract

Background

Typhoid fever typically affects children and young adults and is a considerable cause of morbidity and mortality. Vaccination is the most effective preventive strategy to control typhoid fever in the short to medium term. However, in most endemic countries do not have a typhoid vaccine that is suitable for children below 2 years old.

Methods

This is a randomized, observer blinded phase III trial using Vi-DT typhoid conjugate vaccine and an already WHO licensed prequalified (PQed) typhoid conjugate vaccine (Typbar TCV) as control. About 936 healthy subjects were recruited and divided into 3 age groups: infants group aged 6–24 months, children group aged 2–11 years, adolescents and adults group aged 12–45 years, and followed up till 28 days post vaccination. Blood sample was taken at pre-vaccination and at 28th day post vaccination to evaluate immunogenicity.

Results

The most common immediate local reaction was pain in all age groups, followed by redness. The most common immediate systemic reaction in the infant group was irritability while in the adults and children group was muscle pain. The intensity of reactions was mostly mild and moderate. Severe reactions were in the form of pain and fever. Reactions mostly resolved within 48 h. Seroconversion at 28 days in the Vi-DT group was higher in both adults and children compared to the PQed typhoid conjugate vaccine, Typbar-TCV (p = 1.000; p = 0.250), respectively. The Geometric Mean Titer (GMT) in the Vi-DT group was higher in adults (p = 0134), whereas the PQed typhoid conjugate vaccine Typbar-TCV demonstrated a higher GMT in children and infants (p = 0.277; p = 0.884), respectively.

Conclusion

Vi-DT typhoid conjugate vaccine (Bio-TCV®) is safe and immunogenic in subjects 6 months to 45 years old.

Clinical trial registration number.

NCT04051268, registration date: 09/08/2019.

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6个月至45岁印度尼西亚受试者中Vi-DT伤寒结合疫苗（Bio-TCV®）一个月的安全性和免疫原性评估：一项III期随机临床试验

伤寒通常影响儿童和年轻人，是发病率和死亡率的重要原因。在中短期内，预防接种是控制伤寒最有效的预防策略。然而，在大多数流行国家，没有适合两岁以下儿童的伤寒疫苗。方法：这是一项随机、观察盲法的III期试验，使用Vi-DT伤寒结合疫苗和已经获得世卫组织许可的预审伤寒结合疫苗（Typbar TCV）作为对照。招募健康受试者936人，分为6-24月龄婴儿组、2-11岁儿童组、12-45岁青少年及成人组，随访至接种后28天。接种前和接种后第28天分别采血评价免疫原性。结果各年龄组患者最常见的直接局部反应是疼痛，其次是发红。婴儿组最常见的直接全身反应是易怒，而成人和儿童组是肌肉疼痛。反应强度多为轻度和中度。严重的反应表现为疼痛和发烧。反应大多在48小时内消退。与PQed伤寒结合疫苗Typbar-TCV相比，成人和儿童在28天时的血清转化率更高(p = 1.000；P = 0.250)。Vi-DT组的几何平均滴度（GMT）在成人中较高（p = 0134），而PQed伤寒结合疫苗typbartcv在儿童和婴儿中显示较高的GMT (p = 0.277；P = 0.884)。结论6个月~ 45岁人群接种6 - dt型伤寒结合疫苗（Bio-TCV®）是安全的，具有免疫原性。临床试验注册号。NCT04051268，报名日期：2019年8月9日。

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