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首页> 外文期刊>The American Journal of Tropical Medicine and Hygiene >The 'Performance of Rotavirus and Oral Polio Vaccines in Developing Countries' (PROVIDE) Study: Description of Methods of an Interventional Study Designed to Explore Complex Biologic Problems
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The 'Performance of Rotavirus and Oral Polio Vaccines in Developing Countries' (PROVIDE) Study: Description of Methods of an Interventional Study Designed to Explore Complex Biologic Problems

机译：“发展中国家轮状病毒和口服脊髓灰质炎疫苗的性能”（提供）研究：旨在研究复杂生物学问题的干预研究方法的描述

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摘要

Oral vaccines appear less effective in children in the developing world. Proposed biologic reasons include concurrent enteric infections, malnutrition, breast milk interference, and environmental enteropathy (EE). Rigorous study design and careful data management are essential to begin to understand this complex problem while assuring research subject safety. Herein, we describe the methodology and lessons learned in the PROVIDE study (Dhaka, Bangladesh). A randomized clinical trial platform evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of EE and additional exploratory variables. Methods for the enrollment and 2-year follow-up of a 700 child birth cohort are described, including core laboratory, safety, regulatory, and data management practices. Intense efforts to standardize clinical, laboratory, and data management procedures in a developing world setting provide clinical trials rigor to all outcomes. Although this study infrastructure requires extensive time and effort, it allows optimized safety and confidence in the validity of data gathered in complex, developing country settings.
机译：口服疫苗在发展中国家的儿童看来效果较差。提出的生物学原因包括并发性肠感染，营养不良，干扰母乳和环境性肠病（EE）。严格的研究设计和仔细的数据管理对于开始理解这一复杂问题同时确保研究对象的安全至关重要。在此，我们描述了PROVIDE研究（孟加拉国达卡）中的方法和经验教训。随机临床试验平台评估了延迟剂量的口服轮状病毒疫苗的功效以及可注射的脊髓灰质炎疫苗替代一剂口服脊髓灰质炎疫苗的益处。这种严格的基础设施支持对疫苗性能不佳的假设进行额外的检查。测量了轮状病毒和脊髓灰质炎疫苗的一级和二级功效和免疫原性措施，以及EE的影响和其他探索性变量。描述了登记方法和700名儿童出生队列的2年随访方法，包括核心实验室，安全性，法规和数据管理实践。在发展中国家，为标准化临床，实验室和数据管理程序而付出的巨大努力为所有结果提供了严格的临床试验。尽管此研究基础架构需要大量的时间和精力，但它可以优化安全性，并确保在复杂的发展中国家环境中收集的数据的有效性充满信心。

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