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霍乱疫苗临床试验:临床试验注册库的横断面分析。

Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries.

机构信息

Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa.

Vaccine-Preventable Diseases Programme, World Health Organisation Regional Office for Africa, Brazzaville, Congo.

出版信息

Hum Vaccin Immunother. 2023 Aug;19(2):2261168. doi: 10.1080/21645515.2023.2261168. Epub 2023 Sep 27.

DOI:10.1080/21645515.2023.2261168
PMID:37759348
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10619520/
Abstract

Cholera has been one of the world's biggest public health challenges for centuries. The presence of this disease brings into focus the social determinants of health in different parts of the world. Research and development efforts to find safe and effective Cholera vaccines are critical to decreasing the disease burden from . We searched the International Clinical Trials Registry Platform (ICTRP) and Cochrane Central Register of Controlled Trials (CENTRAL) on 5 March 2023. We included all registered randomized trials studying Cholera vaccines. We used Microsoft Excel to perform a descriptive analysis of the source registry, geographic distribution, recruitment status, phase of trials, and type of trial sponsor and presented the findings using tables and graphs. The search of ICTRP yielded 84 trials, and 315 trials were identified from CENTRAL. Seventy-four trials were included in the analysis. Most of the trials (66%,  = 49) were registered in ClinicalTrials.gov, followed by Clinical Trials Registry - India (9%,  = 7) and the Cuban Public Registry of Clinical Trials (8%,  = 6). The geographical distribution of the trials indicates that 48% ( = 36) of the trials were conducted in Asia, followed by 23% ( = 17) in North America, 15% ( = 11) in Africa, and 11% ( = 8) in Europe. Results further indicate that 81% ( = 60) of trials have a recruitment status "Not recruiting," followed by 12% ( = 9) with a status "recruiting." With the recent surge in Cholera cases and the limited supply of Cholera vaccines, research indicates the need for Cholera vaccine trials to ensure the availability of vaccines, especially in populations affected.

摘要

霍乱是几个世纪以来全球面临的最大公共卫生挑战之一。这种疾病的存在凸显了世界各地的健康社会决定因素。开展研究和开发工作以寻找安全有效的霍乱疫苗对于减轻该疾病负担至关重要。我们于 2023 年 3 月 5 日在国际临床试验注册平台(ICTRP)和考科蓝临床试验注册中心(CENTRAL)进行了检索。我们纳入了所有研究霍乱疫苗的注册随机试验。我们使用 Microsoft Excel 对来源注册处、地理分布、招募情况、试验阶段以及试验赞助商类型进行了描述性分析,并使用表格和图表展示了研究结果。ICTRP 的检索结果为 84 项试验,CENTRAL 则识别出 315 项试验。74 项试验纳入了分析。大多数试验(66%,49 项)在 ClinicalTrials.gov 上注册,其次是 Clinical Trials Registry - India(9%,7 项)和古巴公共临床试验注册处(8%,6 项)。试验的地理分布表明,48%(36 项)的试验在亚洲进行,其次是北美(23%,17 项)、非洲(15%,11 项)和欧洲(11%,8 项)。结果还表明,81%(60 项)的试验处于“未招募”的招募状态,其次是 12%(9 项)的“招募中”状态。鉴于近期霍乱病例激增,霍乱疫苗供应有限,研究表明需要开展霍乱疫苗试验,以确保疫苗的供应,尤其是在受影响的人群中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/b9ed9f78e5f6/KHVI_A_2261168_F0004_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/ead89a71ba29/KHVI_A_2261168_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/16b9efb32ec8/KHVI_A_2261168_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/bcf46c1fcc03/KHVI_A_2261168_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/b9ed9f78e5f6/KHVI_A_2261168_F0004_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/ead89a71ba29/KHVI_A_2261168_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/16b9efb32ec8/KHVI_A_2261168_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/bcf46c1fcc03/KHVI_A_2261168_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce42/10619520/b9ed9f78e5f6/KHVI_A_2261168_F0004_OC.jpg

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Trop Med Health. 2021 Nov 24;49(1):93. doi: 10.1186/s41182-021-00376-2.
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Contrasting Epidemiology of Cholera in Bangladesh and Africa.孟加拉国和非洲霍乱的流行病学对比。
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Modern History of Cholera Vaccines and the Pivotal Role of icddr,b.霍乱疫苗的现代史与 icddr,b 的关键作用
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