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

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 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.

Global Trends in Risk Factors and Therapeutic Interventions for People with Diabetes and Cardiovascular Disease: Results from the WHO International Clinical Trials Registry Platform

“…This geographic distribution highlights the global relevance and collaborative nature of research addressing CVD risk in individuals with diabetes. This also corroborates information from other studies, showing that ClinicalTrials.gov is the predominant source for clinical trial data, informing on many disease conditions [43,47]. This also aligns with increasing trends in data on the prevalence of metabolic disease in developed nations, including the United States [48].…”

“…We conducted searches in the ICTRP, which is a repository hosted by the WHO that contains regularly updated clinical trial data from primary clinical trial registries of the WHO network. Importantly, a growing number of reports have used this registry to analyze and inform on clinical data that remain significant for public health [43][44][45][46].…”

Report of the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) on the microbiological criteria for Vibrio cholerae, as additional control measures at border control posts, applicable to imported frozen prawns and other fishery products

“…In countries where V. cholerae is endemic and there is a high chance of contracting the disease, mass vaccination is a good way to control cholera. Infection with V. cholerae also confers strong immunity, which underlines the viability of preventive vaccination (Mathebula et al, 2023). Authorised by the WHO, three different commercial brands of oral cholera vaccine are currently available (WHO, 2017).…”