A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity.

IF 2.4 Q3 INFECTIOUS DISEASES
Sukamto Koesnoe, Bernie Endyarni Medise, Iris Rengganis, Sri Rezeki Hadinegoro, Mita Puspita, Rini Mulia Sari, Jae Seung Yang, Sushant Sahastrabuddhe, Soedjatmiko, Hartono Gunardi, Rini Sekartini, Angga Wirahmadi, Aria Kekalih, Sreshta Mukhi, Hindra Irawan Satari, Novilia Sjafri Bachtiar
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Abstract

Background: Typhoid fever is commonly found until today, especially in developing countries. It has fatal complications and measures must be taken to reduce the incidence of typhoid. Vaccinations are a key factor in prevention. This is a phase II randomized observer-blind clinical trial on a novel Vi-DT conjugate vaccine on 200 subjects 12 to 40 years of age.

Methods: Subjects were screened for eligibility after which a blood sample was taken and one dose of vaccine was administered. Investigational vaccine used was Vi-DT and control was Vi-PS. Twenty-eight days after vaccination, subjects visited for providing blood sample to assess immunogenicity and were asked about local and systemic adverse reactions that occurred in the first 28 days.

Results: Subjects had minor adverse reactions. Pain was the most common local reaction. Muscle pain was the most common systemic reaction. There were no serious adverse events up to 28 days post vaccination. Seroconversion rates were 100% in the Vi-DT group and 95.96% in the Vi-PS group. Post vaccination GMTs were increased in both groups but it was significantly higher in the Vi-DT group (p < 0.001).

Conclusions: Vi-DT typhoid conjugate vaccine is safe and immunogenic in healthy Indonesian subjects 12 to 40 years.

Trial registration: Approved by ClinicalTrials.gov.

Clinical trial registration number: NCT03460405. Registered on 09/03/2018. URL: https://clinicaltrials.gov/ct2/show/NCT03460405 .

在印度尼西亚健康青少年和成人中开展的 Vi-DT 伤寒结合疫苗 II 期临床试验:为期一个月的安全性和免疫原性评估。
背景:伤寒至今仍很常见,尤其是在发展中国家。它有致命的并发症,因此必须采取措施降低伤寒的发病率。接种疫苗是预防的关键因素。这是一项关于新型 Vi-DT 结合疫苗的 II 期随机观察-盲法临床试验,对象为 200 名 12 至 40 岁的受试者:方法:对受试者进行资格筛查,然后抽取血液样本并注射一剂疫苗。研究用疫苗为 Vi-DT,对照用疫苗为 Vi-PS。接种疫苗 28 天后,受试者前往医院提供血液样本以评估免疫原性,并询问前 28 天内发生的局部和全身不良反应:结果:受试者均有轻微不良反应。疼痛是最常见的局部反应。肌肉疼痛是最常见的全身反应。接种后 28 天内未出现严重不良反应。Vi-DT 组血清转换率为 100%,Vi-PS 组为 95.96%。两组接种后的GMT值均有所升高,但Vi-DT组明显更高(p 结论:Vi-DT组和Vi-PS组的血清转换率分别为100%和95.96%:Vi-DT伤寒结合疫苗对12至40岁的印尼健康受试者是安全的,具有免疫原性:临床试验注册号:NCT03460405:临床试验注册号:NCT03460405。注册日期:2018 年 3 月 9 日。URL: https://clinicaltrials.gov/ct2/show/NCT03460405 .
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.20
自引率
0.00%
发文量
25
审稿时长
17 weeks
期刊介绍: Tropical Diseases, Travel Medicine and Vaccines is an open access journal that considers basic, translational and applied research, as well as reviews and commentary, related to the prevention and management of healthcare and diseases in international travelers. Given the changes in demographic trends of travelers globally, as well as the epidemiological transitions which many countries are experiencing, the journal considers non-infectious problems including chronic disease among target populations of interest as well as infectious diseases.
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