UCD is National Coordinator in EU-wide network to accelerate Covid-19 vaccine Phase 2 and 3 clinical trials
The European Commission has launched a new EU vaccine clinical network to accelerate the trialling of Covid-19 vaccines.
VACCELERATE, the European Corona Vaccine Trial Accelerator Platform, will be the pan-European backbone accelerating Phase 2 and 3 Covid-19 vaccine trials, connecting all stakeholders involved in vaccine development and providing a platform for clinical trial design and conduct. The network now constitutes a rapid response single entry-point for all stakeholders from public health authorities to vaccine developers, to address respective needs and kick-start Phase 2 and 3 vaccine trials.
Phase 2 and 3 clinical trials involve larger numbers of people (several hundred and >3,000 respectively), having passed safety requirements from Phase 1.
There are 21 countries involved in the network including Ireland. Irish Partners are UCD and NUI Galway, led from UCD by Infectious Diseases expert Professor Paddy Mallon, director of UCD Centre for Experimental Pathogen Host Research (CEPHR) and consultant at St Vincent’s University Hospital Infectious Diseases department.
Professor Mallon said: “This initiative forms the basis of a pan-European effort to increase its response to the current pandemic through coordinated clinical and translational research, as well as enabling Europe and Ireland to be better prepared for future pandemics. In my role as National Coordinator for the VACCELERATE network, I will be involved in identifying and linking clinical sites across Ireland to opportunities to participate in vaccine research to enable Ireland and its citizens to fully participate in vaccine research into Covid-19 and other pandemic infections.
“The award to UCD recognises the considerable research undertaken by the university and CEPHR which will play leading roles in developing and validating new assays to be used in vaccine trials as part of VACCELERATE, as well as providing laboratory capacity to this important European Network to assist with specialist laboratory and research capacity.
“This EU funding builds on the track record of CEPHR in conducting research into SARS-CoV-2, including large clinical studies and basic research in our Biosafety Containment Level 3 facility. This award also builds on existing investment by Science Foundation Ireland into COVID-19 research in UCD and CEPHR, including awards focused on developing neutralising assays, bioprofiling studies and sequencing of SARS-CoV-2 as part of the Irish Coronavirus Sequencing Consortium.”
Also involved, director of the UCD Clinical Research Centre and Associate Dean of Research, Innovation and Impact at UCD School of Medicine, Professor Peter Doran said: “An essential component of the VACCELERATE Network will be the alignment of our vaccine trial methods so large-scale, Europe-wide clinical trials can be initiated quickly whilst maintaining the highest regulatory and scientific standards. Our work will diffuse a detailed set of protocols and standards across all the partners, so we can establish new trials quickly.”
Professor Doran added: “The Vaccelerate project represents a unique mobilisation of European research strengths in basic and clinical research. The establishment of this programme will put European science at the leading edge of new vaccine development and testing.”
VACCELERATE will allow capacity mapping of clinical trial and laboratory sites across Europe, to identify suitable sites for individual Phase 2 and 3 vaccine trials. In addition to providing access to laboratories and a standardised set of assays essential for clinical Phase 2 and 3 trials, the network will also build capacity and increase quality across the bloc via shared best practice and training, while volunteer registries will facilitate patient recruitment.
The network will also enable harmonised data collection, open data sharing and pooling of data for stronger analysis. This will help build solutions for characteristic vaccine development issues during pandemics by closing gaps in public health knowledge and improving knowledge transfer.
Beyond the Covid-19 pandemic, VACCELERATE will be an established pandemic preparedness network, ready to face emerging future pandemics and creating structures to test new vaccine candidates fast and effectively. The project will also will organise a Stakeholder Working Group (SWG) that facilitates strategic discussions and identifies unanswered public health needs together with health authorities, vaccine developers, and international vaccine initiatives.