Study on the effectiveness of the ‘booster shot’ against the coronavirus launched
The European Vaccination Research Network VACCELERATE, which is coordinated by the University of Cologne, is beginning a multinational study on the immune response to a third COVID-19 vaccination.
EU-COVAT-1 AGED, the first of three VACCELERATE studies, is starting at University Hospital Cologne on November 9. The study investigates the effectiveness of the so-called ‘booster shot’ against the coronavirus and is led by consortium coordinator Professor Dr Oliver A. Cornely. This phase II clinical trial will be conducted with already approved vaccines and will enrol 600 participants in seven European countries.
In Germany, the debate about who should get a third shot and how this should be organized is well under way. EU-COVAT-1 AGED will examine the effect of a third COVID-19 vaccination on the immune response among study participants aged 75+. This will contribute to answering the question of who should be vaccinated a third time and when. ‘To decide who gets vaccinated a third time, we need better data,’ said Professor Cornely. ‘If we vaccinate everyone a third time on suspicion alone, there won’t be enough doses for low-income countries. With continued high virus circulation, the likelihood of new mutations emerging remains, which is problematic for everyone globally.’
The study enrols participants who have already received two doses of the same vaccine (BioNTech/Pfizer, Moderna or AstraZeneca). The third dose will be administered with the BioNTech/Pfizer or Moderna vaccine. The level of protection against SARS-CoV-2 is then checked at intervals of 14 days, three, six, and twelve months by measuring the level of antibodies in the blood. On 9 November 2021, the first participants will be enrolled in Cologne. In the following months, the trial will be extended to various European countries in order to obtain as much data as possible for meaningful results, considering the diversity of the European population. First results are expected at the beginning of 2022.
‘VACCELERATE allows us to conduct large-scale multinational clinical trials with a wide range of volunteers across the continent,’ Cornely explained. In addition to conducting and coordinating clinical trials, VACCELERATE operates a volunteer registry in which adults and children who are potentially interested in participating in vaccine clinical trials can register. The German volunteer registry is funded by the German Federal Ministry of Education and Research (BMBF). Through VACCELERATE, the registry has been made available in many European countries, always translated into the national language.
VACCELERATE is an academic, pan-European platform that accelerates phase II & III trials of clinical COVID-19 vaccine development in Europe. The network brings together experts from the areas of clinical trial design and conduct, immunology, laboratory standardization and public health from 23 European countries, and lends its expertise to all stakeholders involved in vaccine development. A long-term goal is to pool expertise and accelerate procedures for future pandemics. EU-COVAT-1 AGED is one of three VACCELERATE phase II COVID-19 vaccine trials to be launched in 2021, with a trial on the optimal timing of a third vaccine dose in adults, and a trial on reduced dose regimens in children to follow.
VACCELERATE has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101037867.
Professor Dr Oliver A. Cornely
University Hospital Cologne and Faculty of Medicine, University of Cologne
+49 221 478-85523
Press and Communications Team:
Dr Janina Leckler
+49 221 478-67664