Scientists and doctors at the German Center for Infection Research (DZIF) are working at full speed to put together a research package that pursues ambitious goals. New diagnostic testing methods, antiviral drugs and a vaccine against the new SARS coronavirus are on the agenda. Additional funding has been made available through fast track procedures. The DZIF is initiating research projects and coordinating clinical trials together with the other German Centers for Health Research.
Prevention: Vaccine development
DZIF scientists in München, Marburg and Hamburg are developing a vector vaccine based on genetic information of a SARS-CoV-2 surface protein which is inserted into a vector. Two vectors are being developed in parallel: A modified smallpox virus which has been rendered harmless (MVA) and the measles virus.
Research status: The vaccine is currently being manufactured for use in clinical trials. IDT Biologika filled around 1,000 individual vaccine doses for clinical study phase I. The scientists hope to test first vaccine candidates in phase I clinical trials in humans in September. Phase I clinical trials involve tolerability tests and testing of immune response stimulation. For further development, the scientists are cooperating with the companies IDT Biologika (Dessau) and CanVirex (Basel) for the measle vaccine.
Treatment: Emergency drugs
The development of antiviral drugs could be faster than the development of a new vaccine. In vitro assays and animal models created in the process of vaccine development now also serve as a basis for testing antiviral substances. Especially agents which have already been approved for other indications hold promise as drugs which could be used in the short term. The DZIF is involved in developing different agents:
Prof. Rolf Hilgenfeld and his team at the University of Lübeck succeeded in elucidating the main protease’s precise structure, and consequently develops a first inhibitor termed RHCDS-13b into a drug.
Infection biologists from the German Primate Center - Leibniz Institute for Primate Research in Göttingen, together with DZIF colleagues at Charité Universitätsmedizin Berlin, have investigated how the novel coronavirus SARS-CoV-2 penetrates cells. They have identified a cellular enzyme that is essential for viral entry into lung cells: the protease TMPRSS2. A clinically proven drug known to be active against TMPRSS2, Camostat Mesilate, was found to block SARS-CoV-2 infection and might constitute a novel treatment option.
A team of researchers led by Prof. Florian Klein (Cologne University Hospital) and the German Center for Infection Research (DZIF) has isolated potent SARS-CoV-2 neutralizing antibodies. They have great potential to be used for prevention and treatment of the infection. Together with Boehringer Ingelheim, these antibodies are currently being further characterized and developed. It is expected that they will enter the stage of clinical development later this year.
Study register for SARS-CoV-2 and COVID-19
In order to attain an overview of all clinical trials taking place in Germany and to provide an effective network for the researchers, the Clinical Trial Unit of the DZIF at Cologne University has, for the first time, created a registry for all clinical trial activities taking place in Germany - involving now SARS-CoV-2/COVID 19. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.
LöwenKIDS in a COVID-19 study
Currently, little ist known about children and their susceptibility to the new coronavirus. How many children have already contracted the virus and overcome the infection without any remarkable symptoms? In a DZIF project, scientists now intend to investigate this with the help of 500 "LöwenKIDS".
LEOSS – a European registry
The DZIF and the German Society of Infectious Diseases (DGI) have set up a European case registry which is to collect clinical data of patients with SARS-CoV-2 infection. A special feature of this new registry is that all the data collected will be made available to the scientific community for use in joint analyses. LEOSS is multilingual and is to be implemented across the entire EU. By mid-May, 2000 patient data had already been recorded.
WHO Solidarity Trial
The DZIF and DZL have assumed the role of coordinating the WHO Solidarity Trial in Germany. The World Health Organisation has selected four particularly promising agents or agent combos for testing in a clinical trial programme that is being conducted on thousands of patients in many countries. Specific tests have shown that these agents have efficacy against the new coronavirus and these drugs have already been approved for the treatment of other diseases such as HIV and malaria.
Diagnosis: Rapid and safe tests
Shortly after the outbreak in China in January 2020, DZIF scientists at Charité – Universitätsmedizin Berlin developed the first test for SARS-CoV-2. Using the virus’s genetic information, Prof. Christian Drosten and his team succeeded in developing a test based on the PCR (polymerase chain reaction) technique. The test is currently being used worldwide. Now the aim is to refine the test methods as well as to develop and validate new tests which can be used to determine immune responses in the human body. “We will only be able to develop a vaccine once we know what happens inside the patient’s body,” Drosten explains.
New coalition for resource-pour countries
A group of scientists, physicians, funders, and policy makers from over 70 institutions from over 30 countries have launched an international coalition to respond to COVID-19 in resource-poor settings. DZIF was the first organization in Germany to join the coalition.The COVID-19 Clinical Research Coalition aims to accelerate desperately needed COVID-19 research in those resource-poor settings.