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首页> 外文期刊>Pneumonia. >Rationale and methods of a randomized controlled trial of immunogenicity, safety and impact on carriage of pneumococcal conjugate and polysaccharide vaccines in infants in Papua New Guinea
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Rationale and methods of a randomized controlled trial of immunogenicity, safety and impact on carriage of pneumococcal conjugate and polysaccharide vaccines in infants in Papua New Guinea

机译：巴布亚新几内亚婴儿免疫原性，安全性及其对肺炎球菌结合物和多糖疫苗运输影响的随机对照试验的原理和方法

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Background Children in third-world settings including Papua New Guinea (PNG) experience early onset of carriage with a broad range of pneumococcal serotypes, resulting in a high incidence of severe pneumococcal disease and deaths in the first 2 years of life. Vaccination trials in high endemicity settings are needed to provide evidence and guidance on optimal strategies to protect children in these settings against pneumococcal infections. Methods This report describes the rationale, objectives, methods, study population, follow-up and specimen collection for a vaccination trial conducted in an endemic and logistically challenging setting in PNG. The trial aimed to determine whether currently available pneumococcal conjugate vaccines (PCV) are suitable for use under PNG’s accelerated immunization schedule, and that a schedule including pneumococcal polysaccharide vaccine (PPV) in later infancy is safe and immunogenic in this high-risk population. Results This open randomized-controlled trial was conducted between November 2011 and March 2016, enrolling 262 children aged 1 month between November 2011 and April 2014. The participants were randomly allocated (1:1) to receive 10-valent PCV (10vPCV) or 13-valent PCV (13vPCV) in a 1-2-3-month schedule, with further randomization to receive PPV or no PPV at age 9?months, followed by a 1/5th PPV challenge at age 23?months. A total of 1229 blood samples were collected to measure humoral and cellular immune responses and 1238 nasopharyngeal swabs to assess upper respiratory tract colonization and carriage load. Serious adverse events were monitored throughout the study. Of the 262 children enrolled, 87% received 3 doses of PCV, 79% were randomized to receive PPV or no PPV at age 9?months, and 67% completed the study at 24?months of age with appropriate immunization and challenge. Conclusion Laboratory testing of the many samples collected during this trial will determine the impact of the different vaccine schedules and formulations on nasopharyngeal carriage, antibody production and function, and immune memory. The final data will inform policy on pneumococcal vaccine schedules in countries with children at high risk of pneumococcal disease by providing direct comparison of an accelerated schedule of 10vPCV and 13vPCV and the potential advantages of PPV following PCV immunization. Trial registration ClinicalTrials.
机译：背景技术包括巴布亚新几内亚（PNG）在内的第三世界地区的儿童经历了多种肺炎球菌血清型广泛携带的早期发病，导致严重的肺炎球菌疾病高发，并在生命的头2年死亡。需要在高流行地区进行疫苗接种试验，以提供证据和指导，以保护这些地区的儿童免受肺炎球菌感染的最佳策略。方法本报告描述了在PNG流行和后勤挑战性环境中进行的疫苗接种试验的原理，目标，方法，研究人群，随访情况和标本收集。该试验旨在确定当前可用的肺炎球菌结合疫苗（PCV）是否适合在PNG的加速免疫方案中使用，并且在这一高风险人群中，包括稍后婴儿期的肺炎球菌多糖疫苗（PPV）的方案是否安全且具有免疫原性。结果这项开放随机对照试验于2011年11月至2016年3月进行，招募了262名1个月大的儿童（2011年11月至2014年4月）。参与者被随机分配（1：1）以接受10价PCV（10vPCV）或13 -价PCV（13vPCV），时间为1-2-3个月，在9月龄时进一步随机接受PPV或不接受PPV，然后在23月龄时接受1/5的PPV挑战。总共收集了1229份血液样品以测量体液和细胞免疫反应，并收集1238份鼻咽拭子以评估上呼吸道定植和运输负荷。在整个研究中监测严重的不良事件。在262名儿童中，有87％接受了3剂PCV，79％在9个月时被随机接受PPV或不接受PPV，而67％的孩子在24个月时接受了适当的免疫接种和攻击后完成了研究。结论在此试验期间收集的许多样品的实验室测试将确定不同疫苗时间表和制剂对鼻咽运输，抗体产生和功能以及免疫记忆的影响。最终数据将通过直接比较10vPCV和13vPCV的加速疫苗接种时间表以及PCV免疫后PPV的潜在优势，为患有肺炎球菌疾病高风险儿童的国家的肺炎球菌疫苗接种时间表提供政策依据。试用注册ClinicalTrials。

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