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Background: We sought to develop and test an objective scorecard-based system for assessing and categorizing available research sites in Lassa fever-affected countries based on their preparedness and capability to host Lassa fever vaccine clinical trials.
Methods: We mapped available clinical research sites through interrogation of online clinical trial registries and relevant disease-based consortia. A structured online questionnaire was used to assess the capability of clinical trial sites to conduct Lassa fever vaccine clinical trials. We developed a new scoring template by allocating scores to questionnaire parameters based on perceived importance to the conduct of clinical trials as described in the WHO/TDR Global Competency Framework for Clinical Research. Cutoff points of 75% and 50% were used to categorize sites into categories A, B, or C.
Results: This study identified 44 clinical trial sites in 8 Lassa fever-affected countries. Out of these, 35 sites were characterized based on their capacity to hold Lassa fever vaccine clinical trials. A total of 14 sites in 4 countries were identified as ready to host Lassa fever vaccine trials immediately or with little support.
Conclusion: It is feasible to hold Lassa fever vaccine trials in affected countries based on the outcome of the survey. However, the findings are to be validated through sites' visits. This experience with a standardized and objective method of the site assessment is encouraging, and the site selection method used can serve as an orientation to sponsors and researchers planning clinical trials in the region.
Ever since the 1996 revision of the Declaration of Helsinki, the World Medical Association has attempted to address ethical and scientific concerns of its diverse stakeholders for Articles 33 (use of placebo) and 34 (posttrial provisions), most recently in 2013. Both are inextricably linked to standard of care, an essential element of any comparative, interventional clinical trial. But has this now 20-year-long ethical debate truly been put to rest? The choice of standard of care in clinical trials remains a complex issue, particularly for comparative trials conducted in emerging countries.
A descriptive cross-sectional study of cholera at Kakuma and Kalobeyei refugee camps, Kenya in 2018
(2020)
Introduction: cholera is a significant public health concern among displaced populations. Oral cholera vaccines are safe and can effectively be used as an adjunct to prevent cholera in settings with limited access to water and sanitation. Results from this study can inform future consideration for cholera vaccination at Kakuma and Kalobeyei.
Methods: a descriptive cross-sectional study of cholera cases at Kakuma refugee camp and Kalobeyei integrated settlement was carried out between May 2017 to May 2018 (one year). Data were extracted from the medical records and line lists at the cholera treatment centres.
Results: the results found 125 clinically suspected and confirmed cholera cases and one related death (CFR 0.8%). The cumulative incidence of all cases was 0.67 (95% CI=0.56-0.80) cases/1000 persons. Incidence of cholera was higher in children under the age of five 0.94(95% CI=0.63-1.36) cases/1000 persons. Children aged <5 years showed 51% increased risk of cholera compared to those aged ≥5 years (RR=1.51; 95% CI=1.00-2.31, p=0.051). Individuals from the Democratic Republic of Congo had nearly 9-fold risk of reporting cholera (RR=8.62; 95% CI=2.55-37.11, p<0.001) while individuals from South Sudan reported 7 times risk of cholera case compared to those from Somalia (RR=7.39; 95% CI=2.78-27.73, p<0.001).
Conclusion: in addition to the improvement of water, sanitation and hygiene (WaSH), vaccination could be implemented as a short-medium term measure of preventing cholera outbreaks. Age, country of origin and settlement independently predicted the risk of cholera.