COMBACTE To Support Vaccine Trial Network VACCELERATE
COMBACTE’s LAB-Net and CLIN-Net will actively participate in VACCELERATE, a new vaccine trial network enabling clinical trials for COVID-19 vaccines and preparing Europe for other emerging infectious diseases in the future. VACCELERATE will help determine the safety and efficacy of vaccines in priority groups (e.g. the elderly, pregnant women, and children), and assess efficacy of vaccines for new SARS-CoV-2 variants or for combinations of different existing vaccines (“mix and match”).
VACCELERATE will also act as a single entry point for vaccine developers, including SMEs, who are looking for European infrastructure to carry out vaccine trials, and tap into the COMBACTE network.
LAB-Net will support VACCELERATE by providing ‘state-of-the-art’ laboratory expertise, as well as capacity building to all participating laboratories. Study-specific training will be offered to sites selected to participate in clinical studies. Local laboratories will also take part and will be supplied with sampling materials that will be used in the clinical trials. In addition, it will support local labs in the network to perform exhaustive etiologic diagnosis on the samples collected from patients included in vaccination trials. LAB-Net will also develop and maintain an external quality assessment panel scheme to ensure a high-performance level of the laboratories within clinical studies. Last but not least, all collected clinical samples will be reconciled at the LAB-Net central laboratory and stored in a biobank. They will be subject to extensive analysis and will also be used for developing or adapting existing diagnostic tests, as well as to inform further clinical studies.
CLIN-Net will support VACCELERATE with the development and training of a European network of fully capable and Good Clinical Practice (GCP)-compliant vaccine trial sites. CLIN-Net will assist with the mapping of clinical trial sites in 21 European countries for both pediatric and adult trials. Using the experience of the COMBACTE project, CLIN-Net will also help establish a transparent site selection procedure. GCP courses for personnel of sites selected to participate in clinical studies will be offered through CLIN-Net. In addition, vaccine trial-specific training will be provided. This will not only drive capacity building but will also enable quality standardization and harmonization across Europe.
VACCELERATE will be part of a European bio-defense preparedness programme called “HERA Incubator” to address the emerging threat of coronavirus variants as announced by the European Commission on February 17th, 2021. These research investments supporting the HERA Incubator will be the first under Horizon Europe, the EU’s new research and innovation programme.
VACCELERATE will receive a €12 million grant to support the rapid establishment of a clinical research network already spanning 21 countries, while other countries are encouraged to join. It will work in close collaboration with the European Medicines Agency (EMA)– a Europe-wide network of more than 1,000 clinical study sites and laboratories in 41 countries.
The VACCELERATE project involves 26 partners in 16 Member States (AT, BE, CY, DE, DK, EL, ES, FR, IE, IT, LT, NL, PL, PT, SE, SK) and 5 associated countries (CH, IL, NO, RS, TR), led by University-Hospital Köln. The network will organise a Stakeholder Working Group (SWG) that facilitates strategic discussions and identification of pressing unanswered public health needs. The SWG will gather the European Medicines Agency (EMA) and national regulatory bodies, as well as the European Centre for Disease Prevention and Control (ECDC), and other relevant European and international actors. As of January 2021, VACCELERATE centralised information for more than 180 vaccine trial sites in 30 European countries on their capacity to perform vaccine trials (hospitals, primary care, paediatric networks, etc). The mapping will also identify the most suitable laboratories for vaccine trials, and specific vaccine-trial related training will be provided when needed. Finally, VACCELERATE will work towards standardised data management and support the timely sharing of data.
About HERA Incubator
On February 17th, 2021, the European Commission presented a Communication for the proposed launch of a European bio-defence preparedness programme called “HERA Incubator” to address the emerging threat of coronavirus variants. Plans include important new research investments, mobilising an additional €30 million from Horizon 2020 to be complemented by a further €120 million from Horizon Europe.
The new programme will provide the means to detect and counter further coronavirus mutations, and help ensure access to effective vaccines when a new virus or variant has emerged. Horizon 2020 funding will support the rapid establishment of a new EU-wide vaccine trial network called VACCELERATE and boost capacities to track and analyse virus variants and to share data by reinforcing the European COVID-19 Data Platform and other existing research infrastructure projects and networks. Horizon Europe funding will complement this action by providing further support for open data sharing, cohorts studies and for vaccine trials.
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