At the end of last year, the Bavarian Ministry of Science announced the participation of Hof University of Applied Sciences in the large Bavarian accompanying study on the effectiveness of the SARS-CoV-2 vaccination. A major goal of the researchers involved in CoVaKo-2021 is to analyze the course of infection in those vaccinated who go through an infection despite the vaccination. Preliminary work has been implemented at the Institute for Information Systems at Hof University of Applied Sciences (iisys). Prof. Dr. Beatrix Weber and Prof. Dr. Jörg Scheidt inform about the current status.
The CoVaKo study is being conducted by the six Bavarian university hospitals in Erlangen, Munich, Würzburg, Regensburg and Augsburg and in close collaboration with the Bavarian State Office for Health and Food Safety (LGL). How did the Hof University of Applied Sciences become involved and what does this mean for your institute?
It is undoubtedly a great honor for our institute to be allowed to participate here, and at the same time a recognition for the work of the past years!Prof. Dr. Jörg Scheidt
Our participation has resulted in several respects from earlier projects. For example, on the topic of migraine in elementary school children, we are collaborating with professors from LMU Munich, including Prof. von Kries. He is a member of the Permanent Vaccination Commission of the RKI. He recommended Hof University of Applied Sciences for the technical implementation to Prof. Überla from Erlangen, who is also a member of the StIKo and is the lead investigator of the CoVaKo study. In a further cooperation with physicians of the LMU Munich – here on the subject of the headache register – the involvement of our research groups Law and Analytical Information Systems has also proved successful. It was therefore decided to use this cooperation for the CoVaKo study as well.
How can CoVaKo contribute to the safety of vaccinations, i.e. what are the medium- and long-term benefits for the general public?
Roughly speaking, the goal of the research is to compare the corona disease courses of patients with and without vaccination in order to obtain reliable data on the efficacy of the vaccines. To do this, we use criteria such as severity, duration, symptomatology, type and frequency of complications, hospital admissions, and mortality. In addition, we also investigate the immune response depending on the virus variant, i.e., which influencing factors can affect the course of infection.
In order to be able to do this, the health authorities report to us the so-called “breakthrough infections”, i.e. those who have contracted the virus despite vaccination. If they are eligible and have given their consent to participate in the study, their data are included. We then compare the data with a control group, i.e., those infected with Covid but who had not been vaccinated. Specifically, this means that the quarantined subjects are closely examined at 5 to 6 appointments. To the extent that the subjects are being treated in a clinic, the data collected in the clinic can also be used. The hope and expectation of the medical researchers is that vaccinated subjects will have less severe courses. This would then prove that the vaccines have a positive effect even in those who fall ill despite vaccination
This is highly significant for science: information is obtained about how many “breakthrough infections” there are, i.e. how many become infected despite vaccination. The selection of vaccines and the vaccination strategy could thus be adjusted accordingly.
So what specifically is the task of the Hof research groups, what part of the study do you cover, and where do the biggest challenges lie for your teams?
Together with smartlytic GmbH – a spin-off of our research group that is based at the digital start-up center Einstein 1 – we are taking on the technical part, i.e. designing and creating the software for recording, storing as well as providing the data for evaluation. The challenge is to document the visits of the university hospitals as standardized as possible, so that the data of all six hospitals can be evaluated together. The key problem here is often time: the opportunity to investigate breakthrough infections only presents itself when the incidence is quite high. Therefore, the preparatory work had to be done quickly in order to find enough subjects for the study.
In addition, we are operating in a highly complex system, in which up to 1200 pieces of information are included per visit record, and up to 400 more per hospitalization.
The Legal Research Group at iisys has designed the data collection and processing to comply with data protection requirements. This includes taking into account the special protection of health data and conducting a so-called data protection impact assessment.
Secondly, for studies on humans, votes must be obtained from the ethics committees of the university hospitals involved. Here, we supported the medical researchers in obtaining the votes and, in particular, in complying with the requirements of medical law when implementing them in the research project.
That sounds like a lot of work. What preliminary work was necessary and how many people are involved in the work at Hof?
In the phase of creating our data entry software, 4 employees worked full-time over a good three months. In the phase of data collection and evaluation, one or two employees will continue to be involved in the project. In addition, there was a lot of small stuff. One example: for the 600 patients, 65 each, or a total of just under 40,000 labels for labeling sample tubes were printed with barcodes and sent to the project partners.
We worked with four employees at the beginning for the data protection concept and impact assessment. Now, one employee is responsible for monitoring the project.
Are you building on existing solutions or are new technical developments necessary?
In the case of the software, experience from previous projects plays a role. If you had to start from scratch, such a system would not be feasible in such a short time. But there are also always new challenges and problems that have to be overcome.
We already had very good expertise in data use for new technologies and also in healthcare. What was new was to consider the special situation of COVID patients as subjects. For this, the multiple amendments to the Infection Protection Act and the current recommendations of the ethics committees had to be sifted through and taken into account.
What is the current status and what happens next in the project?
Fortunately, the preparatory work has now been completed, which means that subjects have been enrolled in the study since last week. During the ongoing data collection, the systems are being maintained, support is being provided for the study physicians and the analysis of the data is being prepared. In addition, statistical evaluations are regularly made available for monitoring the data collection, so that it is possible to see at any time whether the age and gender distributions in the group of subjects and the control group match.
The data protection support does not end with the start of a project; current questions from the data protection and medical law area arise again and again.Prof. Dr. Beatrix Weber
The circle of participants – as shown above – has rank and file. How is the cooperation with the project partners structured and where are the points of contact?
The conception phase between January and May was, of course, characterized by intensive collaboration – especially with regard to coordination with the project coordinator at the University of Erlangen. Countless e-mails, phone calls and Zoom meetings “sweetened” the weekends for those involved. Of course, there will also be regular online project meetings of all participants during the actual implementation.
We have earned a great deal of admiration from the virologists involved. The motivation and precision in detail with which the research is carried out is very impressive.
A big issue – especially in times of digitalization – is the question of data protection and data security. How is it ensured that personal data does not fall into the wrong hands?
Misuse of the data is ruled out as far as the state of the art allows. We ensure this in Hof. We only use anonymized laboratory tests and anonymized test person data. This means that neither the names nor the addresses of the test persons are stored in the research database in Hof. The data is also analyzed only on the basis of subject codes. And finally, data transmission is always encrypted.
It is often said that research conditions in the USA are much better. With medical research using personal data, on the other hand, we can also create legal trust in this high-quality research at the location of Germany.
When can you expect the project to be completed?
The study will initially run for 2 years. But the evaluations and subsequent publication of the results will certainly take longer. It is also planned to use the structures already created and to establish longer-term virological monitoring in order to uncover new virus variants. Of course, we hope for a longer-term cooperation of the project partners!
Thank you very much for the interview!