LAB-Net Provided Training to CoVacc Sites
On May 19 LAB-Net, the Central Laboratory at the University of Antwerp, provided training on the sampling and microbiology procedures to the first CoVacc site that will take part in the paediatric VACCELERATE study.
CoVacc is a phase 2, comparative randomised trial to evaluate the impact of reduced COVID-19 mRNA vaccination regimen on immunological responses and reactogenicity in paediatric subjects with prior SARS-CoV-2 immunity. Microbiologists, technicians and study nurses from University Medical Centre Utrecht attended the online training session. Prior to the training, LAB-Net developed a sample collection & management manual and sampling instructions for the sites, in collaboration with the clinical team. The local study team was also provided with sample kits that were prepared and shipped by the central laboratory at the University of Antwerp. The first subject is expected to be enrolled in June 2022.
The objectives of CoVacc are:
- To determine if the humoral immune response of a single compared to a two dose COVID‐19 vaccination regimen is non‐inferior in paediatric subjects who are immunologically primed by natural infection.
- To assess the safety and reactogenicity profile of a single dose COVID‐19 vaccine regimen against SARS‐CoV‐2 in paediatric subjects with a history of prior SARS‐CoV‐2 infection, compared to the two dose regimen.
- To assess the medium (6 months) and long term (12 month) humoral immune response of the single COVID‐19 vaccine dosing regimen against wild‐type SARS‐CoV‐2 in paediatric subjects with a history of prior SARS‐CoV‐2 infection.
- To assess the short (28 days), medium and long term humoral immune response of the single dose COVID‐19 vaccine regimen against SARS‐CoV‐2 variants of concern (VoCs) in paediatric subjects with a history of prior SARS‐CoV‐2 infection.
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 CoVacc
EU-COVPT-1 (CoVacc) is a Phase 2, Comparative Randomised Trial to Evaluate the impact of reduced COVID-19 mRNA vaccination regimen on immunological responses and reactogenicity in paediatric subjects with prior SARS-CoV-2 immunity. The study team is located at University Medical Centre Utrecht, The Netherlands, and led by Patricia Bruijning-Verhagen.
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