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Novel vaccine clinical trials in Africa
European Statement
Education and Research
Author(s)
Trudi Hilton
Why was it done?
The Partnership for Research on Ebola VACcination (PREVAC) established a randomised, double-blind, placebo-controlled, phase 2 study evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. Pharmacists from all PREVAC participating country teams were introduced at collaborative calls where the study protocol was presented.
What was done?
UK Hospital Pharmacists with clinical trials experience worked with London School of Hygiene and Tropical Medicines (LSHTM) research teams in Sierra Leone and pharmacists from there, France, Guinea, US and Liberia to establish the Standard Operating Procedures and protocols required to compare two novel vaccines for Ebola Virus Disease (EVD).
How was it done?
The trial pharmacy teams met virtually each month to discuss the development of Standard Operating Procedures to store and prepare the vaccines. We started by ensuring an appropriate space within the research site was identified for the pharmacy. We advised on the equipment required for aseptic preparation, temperature monitoring and controlled storage of Investigational Medicinal Products (IMP). Solar fridges were identified for IMP storage at 2-8 deg C and ambient 15-25 deg C products, with freezers being run on generators. We developed protocols and documents for temperature monitoring and back-up plans for the failure of cooling devices. I set up trial dispensing procedures to enable preparation of the vaccine for ‘blind’ administration. The local pharmacy team advised on the equipment required to work aseptically. Sourcing specialist equipment, much of which is not available locally, takes considerable time so this work was undertaken several months before participant recruitment began, ensuring that it could be calibrated and validated before receipt of IMP.
What has been achieved?
Pharmacists from France and the UK have worked with local colleagues to develop best practice for clinical trials in resource-limited, tropical settings. This learning is invaluable for the future development of vaccines.
https://www.semanticscholar.org/paper/Partnership-for-Research-on-Ebola-VACcination-of-a-Badio-Lhomme/e70c6224c89e28481ea278ca43ee51d163645fea
What next?
Clinical trials must be carried out in the context in which the investigational medicinal product is intended for use, at standards required to achieve EMEA and FDA authorisations. EU hospital clinical trials pharmacists working with university research teams can support their pharmacy colleagues in these settings to ensure optimisation of IMP storage, handling and preparation with accurate record keeping..