Cochrane South Africa, South African Medical Research Council, Parow Valley, 7501, Cape Town, South Africa.
HIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Durban, 4091, South Africa.
Trials. 2022 Nov 17;23(1):945. doi: 10.1186/s13063-022-06878-6.
Rotavirus is a primary infectious virus causing childhood diarrhoea and is associated with significant mortality in children. Three African countries (Nigeria, the Democratic Republic of Congo, and Angola) are among the five countries that account for 50% of all diarrheal-related deaths worldwide. This indicates that much needs to be done to reduce this burden. The World Health Organization International Clinical Trial Registry Platform (WHO ICTRP) is a global repository for primary registries reporting on clinical trials. This study aimed to identify and describe planned, ongoing, and completed rotavirus vaccine trials conducted globally.
We searched WHO-ICTRP on 17 June 2021 and conducted a cross-sectional analysis of rotavirus studies listed in the database. Data extraction included trial location, participant age, source of the trial record, trial phase, sponsor, and availability of results. We used the Microsoft Excel 365 package to generate descriptive summary statistics.
We identified 242 rotavirus vaccine trials registered from 2004 to 2020. Most of these trials were registered retrospectively, with only 26% of the rotavirus vaccine trials reporting the availability of results in their registries. Most of the trials are studying children aged less than 5 years. The recruitment status for these trials is currently shown in the WHO-ICTRP as "not recruiting" for 80.17% of trials, "recruiting" for 11.57% of trials recruiting, and unknown for 6.61% of trials. The continents in which these rotavirus vaccine trials have recruitment sites in Asia (41%) and North America (20%), with the maximum number of trials in the clinical trial registries coming from India (21%) and the USA (11%) with most being sponsored by the pharmaceutical industry. Our analysis shows that only 26% of the rotavirus vaccine trials report the availability of results in their registries.
Mapping rotavirus vaccine clinical trial activity using data from the WHO ICTRP beneficial provides valuable information on planned, ongoing, or completed trials for researchers, funders, and healthcare decision-makers. Despite the high rotavirus disease burden in low- and middle-income countries, including Africa, there is minimal clinical trial activity related to the condition on the continent. The clinical trial registries as a valuable tool to share interim results of the trials.
轮状病毒是导致儿童腹泻的主要传染性病毒，与全球儿童腹泻相关死亡的 50%有关。尼日利亚、刚果民主共和国和安哥拉这三个非洲国家是占全球所有腹泻相关死亡 50%的五个国家之一。这表明，需要做很多工作来减轻这一负担。世界卫生组织国际临床试验注册平台（WHO-ICTRP）是一个全球存储库，用于报告临床试验的主要登记处。本研究旨在确定和描述在全球范围内进行的计划、进行中和已完成的轮状病毒疫苗试验。
我们于 2021 年 6 月 17 日在世界卫生组织国际临床试验注册平台上进行了搜索，并对数据库中列出的轮状病毒研究进行了横断面分析。数据提取包括试验地点、参与者年龄、试验记录来源、试验阶段、赞助商和结果可用性。我们使用 Microsoft Excel 365 软件包生成描述性汇总统计数据。
我们确定了 2004 年至 2020 年期间注册的 242 项轮状病毒疫苗试验。这些试验大多是回顾性注册的，只有 26%的轮状病毒疫苗试验在其登记处报告了结果的可用性。大多数试验都在研究年龄小于 5 岁的儿童。目前，这些试验在世界卫生组织国际临床试验注册平台上的招募状态显示，80.17%的试验为“不招募”，11.57%的试验为“招募中”，6.61%的试验为“未知”。这些轮状病毒疫苗试验在亚洲（41%）和北美（20%）有招募地点，临床试验登记处中试验数量最多的是印度（21%）和美国（11%），大部分由制药行业赞助。我们的分析表明，只有 26%的轮状病毒疫苗试验在其登记处报告了结果的可用性。
利用世界卫生组织国际临床试验注册平台的数据绘制轮状病毒疫苗临床试验活动图，为研究人员、资助者和医疗保健决策者提供了有关计划、进行中和已完成试验的宝贵信息。尽管包括非洲在内的低收入和中等收入国家的轮状病毒疾病负担很高，但该大陆与该疾病相关的临床试验活动很少。临床试验登记处是分享试验中期结果的宝贵工具。
