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Project Topic
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CERMEL is qualified to conduct high quality clinical trials. However, the site continues to outsource several laboratory assays to partners. During a recent Ebola vaccine trial a molecular assay to detect the vaccine (viral) replication needed to be outsourced with a partner in UK while daily results of this assay would have supported the safety monitoring of study participants. The current project aimed to upgrade the biosafety and technical capabilities at CERMEL with the aim to become a referral centre for some molecular and immunological assays. In addition, we proposed to develop a decision making framework to support the public health decision making in case of the occurrence of an EVD outbreak. With the support of the current capacity building grant entitled, Vaccine trials and deployment towards sustainability of Ebola Virus Diseases control (Acronym: EDCTP-CSA-Ebola-363-SECC), CERMEL has upgraded its biosafety management system. The biosafety manual has been revised and includes now standards to maintain safety in levels 2 and 3 laboratories, collect, handle samples that need to be shipped to BSL 4 laboratory. In addition, a biological waste management plan has been set up according to international standards and national regulations. A biosafety committee has been established and is operational. We have set up a quantitative real time polymerase chain reaction assay (qPCR) to detect and quantify ribonucleic nucleic acids (RNA) in plasma of people immunised with a vaccine against Ebola disease made with a vector: a replication competent attenuated vesicular stomatitis virus. The assay has been set up using an external quality control plan from the St George’s University of London. The procedure is now well established and laboratory staff trained. During the next phase 2 trial in children, the assay will be performed at CERMEL on a daily basis to monitor the replication of the vector and thus increase the monitoring of safety for the participants. While CERMEL can already perform this assay in the context of multicenter trials using an external quality control system, the site is in process to get the assay accredited together with the procedure of detecting and quantifying viral RNA replication to become a referral center. The following new training packages were elaborated as part of the activities of this grant: - Principle for levels 2 and 3 biosecurity in laboratories - Serological and molecular biology testing for surveillance and response to viral epidemics (introduction and theoretical principles). - Practical serological and virological (molecular biology, qPCR) testing of Flaviviridaes (e.g. Dengue virus) - Exploratory serological and virological testing of RNA in suspected dangerous sample and decision making for their transfer to a BSL 4 laboratory. Various training took place at CERMEL. For the following modules: principles for levels 2 and 3 biosecurity in laboratories, Serological and molecular biology testing for surveillance and response to viral epidemics (introduction and theoretical principles), practical serological and virological (molecular biology, qPCR) testing of Flaviviridaes (e.g. Dengue virus), key representatives of main public health and research institutions in Gabon attended the training. The current grant has funded an important meeting of key stakeholders involved in clinical trials: researchers, ethicists, regulatory people, health professionals, representative of the community. Participants from Gabon, Congo, Benin, Germany, The Netherlands, attended a four day meeting named “African congress for clinical trials (ACCT)”. ACCT aims to be a major scientific event in Africa that will annually bring together the key actors involved in clinical trials (https://www.africancct.org/ ). As part of activities related to the set up of a decision making framework, the national plan of preparedeness and responses to Ebola virus disease has been revised by an expert. Upon the expert review and advice from the representative of World Health Organization, we set up the decision making framework as an evidence review board, a self sustainable not for profit organisation. The evidence review baord is allocated with the task to review scientific evidence of new strategies and interventions against Ebola and provide the algorithm of their use in case of EVD outbreak.
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