LAB-Net Highly Involved in AGED and BOOSTAVAC

AGED and BOOSTAVAC have the following objectives:

1. To evaluate immune response against wild-type SARS-CoV-2 and against variants of concern of SARS-CoV-2 in (elderly) individuals already fully vaccinated against SARS-CoV-2;
2. To evaluate the long-term humoral immune response (reactogenicity and immunogenicity) of different booster strategies in (elderly) individuals already fully vaccinated against SARS-CoV-2;
3. To assess the safety of different booster strategies in (elderly) individuals vaccinated against SARS-CoV-2;
4. To investigate the cellular immune response after a 4th vaccination dose against SARS-CoV-2, virus neutralising capacity against newly emerging variants.

With regards to the AGED study, LAB-Net trained and provided sample kits and manual to 6 sites in Spain, Norway and Germany  that are open for recruitment. LAB-Net trained a further two sites in Spain and Lithuania that are expected to be activated and start to enrol subjects any time soon. Furthermore, one additional site in Germany as well as in Lithuania will be initiated soon and 5 additional sites in Ireland are expected to receive regulatory approval and can then be initiated and activated as well.. For the BOOSTAVAC study, two Irish sites are actively recruiting, while a third one has already been trained, received all the necessary materials and is waiting for green light, with 10 subjects on the waiting list.

For both studies, LAB-Net was involved in the selection of the clinical trial sites. Furthermore, LAB-Net developed a Sample Collection and Management Manual, organised a laboratory training on sample collection and management procedures, and provided investigational sites with all necessary materials for the collection and processing of EDTA blood, Lithium heparin blood, and serum. In the future, LAB-Net will continue to provide sites with study material. When sample collection is up and running, samples will be shipped at regular timepoints from the local sites to the Central Laboratory where they will be biobanked. Aliquots obtained for the determination of trial endpoints will be shipped to two central laboratories based at:

1. The Instituto de Salud Carlos III in Madrid, for the application of qPCR to measure the cellular immune response;
2. The Centre for Experimental Pathogen Host Reearch (CEPHR) in University College Dublin, for the analysis of the presence of anti-RBD, anti-S1 and anti-N antibody samples as well as live virus neutralising capacity assays against both wild type virus and common variants of concern.

The above analyses will be run on all samples or on subgroups only, as specified in each protocol.

ABOUT VACCELERATE

VACCELERATE is the pan-European backbone for the acceleration of phase 2 & 3 COVID-19 vaccine trials. The network is comprised of academic institutions from all over Europe. The consortium is led by the University of Cologne, Germany, and currently includes 29 national partners in 18 EU-member states and 5 countries associated to the EU Horizon 2020 research programme.

VACCELERATE is funded by the European Commission’s activities for future pandemic preparedness, the HERA Incubator, an instrument that was created in analogy to the United States’ BARDA.

The overall objective is to connect all European stakeholders involved in vaccine development to provide  a pan-European platform for clinical trial design and conduct.

ABOUT AGED and BOOSTAVAC

EU-COVAT-1-AGED: A multinational, phase 2, randomized adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines administration in older adults (≥75) already vaccinated against SARS-CoV-2.  The study team is located at University of Cologne, Cologne, Germany and lead by Oliver Cornely.

EU-COVAT-2-BOOSTAVAC: An International Multicentre, Phase 2, Randomised, Adaptive Protocol to determine the need for, optimal timing of, and immunogenicity of administering a 4^th  homologous vaccination dose against SARS-CoV-2 in the general population (18+ years) already vaccinated with the BNT162b2 vaccine. The study team is located at University College Dublin, Dublin, Ireland and lead by Patrick Mallon.