Willingness to volunteer for COVID-19 vaccine trials is high. But what trials are underway and who can be contacted for further information? To answer these questions and to match interested individuals with clinical trials, a central participant registry is created at the German Center for Infection Research (DZIF). Supported by the German Ministry of Education and Research (BMBF), the DZIF Clinical Trial Unit at the University Hospital Cologne is setting up a platform across Germany and Europe that provides an overview of experienced clinical trial sites for testing vaccines against the new coronavirus.
Phase III clinical trials are an important and necessary step toward approval for COVID vaccines. Following Phases I and II with up to 500 study participants, safety and efficacy of a vaccine candidate needs to be confirmed in a Phase III clinical trial with several thousand individuals. The Phase III trial of the vaccine currently developed within DZIF is targeting an enrolment goal of 14,000 volunteers. According to the German Association of Research-Based Pharmaceutical Companies, 169 vaccines worldwide are currently under development, eight of which have started Phase III trials. However, North and South America are preferred study locations for many trials as consistently high regionwide infection rates compared to Europe promise quicker results.
"There is a risk that the EU will take a backseat when it comes to participating in the most important COVID-19 vaccine trials," cautions infectious diseases expert Prof. Oliver Cornely, who develops the European platform and the participant registry within DZIF. Restricting vaccine testing to few geographic regions also runs the risk of introducing epidemiological bias to trial results. Cornely aims to build a platform of high-performing EU clinical trial sites that can rapidly roll out COVID-19 vaccine trials with sponsors from academia and pharmaceutical industry. In parallel, a German participant registry for COVID-19 vaccine trials is set up to boost Germany as study location.
Would you like to participate in a COVID-19 vaccine trial in Germany?
Accessing a short electronic questionnaire, interested adults from all over Germany submit a limited set of personal data to the participant registry at the University Hospital Cologne. Questions include the place of residence an willingness to travel to a trial site as well as pre-existing conditions and potential previous COVID-19 infection.
If a corona vaccine trial matches a participant profile the team at the University Hospital Cologne will get in contact via email. Registered individuals then decide for themselves whether they want to contact the vaccine trial organizers to participate. Corona vaccine studies are organized by university hospitals, pharmaceutical companies and other institutions or facilities.
Registering is not a commitment to actually participate in a clinical trial and can be revoked at any time. Submitted data is never be passed on to third parties.
Link to the participant registry: www.impfstudien-corona.de/index_eng.html
Link to the European Vaccine Trial Accelerator Platform: https://euvap.eu/