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

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 decreasin...

Full description

Bibliographic Details
Main Authors: Lindi Mathebula, Thobile Malinga, Mammekwa Mokgoro, Duduzile Ndwandwe, Charles S. Wiysonge, Glenda Gray
Format: Article
Language:English
Published: Taylor & Francis Group 2023-08-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
Online Access:http://dx.doi.org/10.1080/21645515.2023.2261168
_version_ 1797633699588603904
author Lindi Mathebula
Thobile Malinga
Mammekwa Mokgoro
Duduzile Ndwandwe
Charles S. Wiysonge
Glenda Gray
author_facet Lindi Mathebula
Thobile Malinga
Mammekwa Mokgoro
Duduzile Ndwandwe
Charles S. Wiysonge
Glenda Gray
author_sort Lindi Mathebula
collection DOAJ
description 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 Vibrio cholerae. 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%, n = 49) were registered in ClinicalTrials.gov, followed by Clinical Trials Registry – India (9%, n = 7) and the Cuban Public Registry of Clinical Trials (8%, n = 6). The geographical distribution of the trials indicates that 48% (n = 36) of the trials were conducted in Asia, followed by 23% (n = 17) in North America, 15% (n = 11) in Africa, and 11% (n = 8) in Europe. Results further indicate that 81% (n = 60) of trials have a recruitment status “Not recruiting,” followed by 12% (n = 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.
first_indexed 2024-03-11T11:57:34Z
format Article
id doaj.art-2c0660d8942e4568ba031d152dc4c23c
institution Directory Open Access Journal
issn 2164-5515
2164-554X
language English
last_indexed 2024-03-11T11:57:34Z
publishDate 2023-08-01
publisher Taylor & Francis Group
record_format Article
series Human Vaccines & Immunotherapeutics
spelling doaj.art-2c0660d8942e4568ba031d152dc4c23c2023-11-08T11:55:20ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2023-08-0119210.1080/21645515.2023.22611682261168Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registriesLindi Mathebula0Thobile Malinga1Mammekwa Mokgoro2Duduzile Ndwandwe3Charles S. Wiysonge4Glenda Gray5South African Medical Research CouncilSouth African Medical Research CouncilSouth African Medical Research CouncilSouth African Medical Research CouncilSouth African Medical Research CouncilSouth African Medical Research CouncilCholera 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 Vibrio cholerae. 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%, n = 49) were registered in ClinicalTrials.gov, followed by Clinical Trials Registry – India (9%, n = 7) and the Cuban Public Registry of Clinical Trials (8%, n = 6). The geographical distribution of the trials indicates that 48% (n = 36) of the trials were conducted in Asia, followed by 23% (n = 17) in North America, 15% (n = 11) in Africa, and 11% (n = 8) in Europe. Results further indicate that 81% (n = 60) of trials have a recruitment status “Not recruiting,” followed by 12% (n = 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.http://dx.doi.org/10.1080/21645515.2023.2261168choleracholera vaccinesvaccinesclinical trialsrandomised controlled trials
spellingShingle Lindi Mathebula
Thobile Malinga
Mammekwa Mokgoro
Duduzile Ndwandwe
Charles S. Wiysonge
Glenda Gray
Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries
Human Vaccines & Immunotherapeutics
cholera
cholera vaccines
vaccines
clinical trials
randomised controlled trials
title Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries
title_full Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries
title_fullStr Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries
title_full_unstemmed Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries
title_short Cholera vaccine clinical trials: A cross-sectional analysis of clinical trials registries
title_sort cholera vaccine clinical trials a cross sectional analysis of clinical trials registries
topic cholera
cholera vaccines
vaccines
clinical trials
randomised controlled trials
url http://dx.doi.org/10.1080/21645515.2023.2261168
work_keys_str_mv AT lindimathebula choleravaccineclinicaltrialsacrosssectionalanalysisofclinicaltrialsregistries
AT thobilemalinga choleravaccineclinicaltrialsacrosssectionalanalysisofclinicaltrialsregistries
AT mammekwamokgoro choleravaccineclinicaltrialsacrosssectionalanalysisofclinicaltrialsregistries
AT duduzilendwandwe choleravaccineclinicaltrialsacrosssectionalanalysisofclinicaltrialsregistries
AT charlesswiysonge choleravaccineclinicaltrialsacrosssectionalanalysisofclinicaltrialsregistries
AT glendagray choleravaccineclinicaltrialsacrosssectionalanalysisofclinicaltrialsregistries