Clinical trials for SARS-CoV-2 vaccine set to start September
Joint press release: Philipps-Universität Marburg, German Center for Infection Research (DZIF), Ludwigs-Maximilians-Universität München (LMU) and University Medical Center Hamburg-Eppendorf (UKE)
Image of a negatively contrasted SARS-CoV-2 particle. It was taken with a transmission electron microscope and coloured at Marburg University.
Joint vaccine development under the roof of the DZIF: Vaccine is currently being manufactured for use in clinical trials
A potential vaccine against SARS-CoV-2 is to undergo first clinical trials on humans as early as this year. “The vaccine’s building plan has been completed and now it needs to be manufactured for use in clinical trials,” explains Prof. Stephan Becker, Director of the Institute of Virology at Marburg University and Coordinator of the research area “Emerging Infections” at the German Center for Infection Research (DZIF). “We now fulfil all the financial and logistic requirements and can start a clinical phase I trial soon,” he adds. This clinical trial phase will investigate the vaccine’s tolerability and ability to activate immune responses. The immune monitoring, i.e. the characterisations of antibody responses to the vaccine, will take place in Marburg.
Vaccine approval “is not achievable within a few weeks”
The company IDT Biologika in Dessau is currently manufacturing the vaccine for use in the clinical phase I trial. The production is expected to be complete in three months and consequently clinical trials will be started in September. Although this development has been much swifter than in previous procedures, it will still not be possible to make a new vaccine available this year. “Developing a vaccine is a lengthy, tedious process, particularly the clinical trials for candidate approval. This is not achievable in just a few weeks,” emphasizes Becker.
Prof. Gerd Sutter from LMU Munich led the development of the vaccine candidate which is now ready for clinical phase I trials. The candidate is a so-called vector vaccine and uses the “modified vaccinia virus Ankara” (MVA) as a viral vector. MVA was developed at the LMU as a vaccine against smallpox over 30 years ago. MVA viruses are attenuated in such a way that they can be used as harmless vectors in other vaccines.
“With this, we now have a platform technology, which we can use to bring any new genetic information under the control of the viral vector. This is a well-established vector system, for which large-scale production has already been implemented. The basic virus has been fully characterised and clinically tested together with genetically altered variants in over 12,000 people. We are very familiar with both the basic vaccine’s side-effect profile and immunogenicity,” emphasizes Gerd Sutter. At the DZIF, this vector has already been used to successfully develop a vaccine against the MERS coronavirus, which is closely related to SARS-CoV-2. First clinical trials on this MERS vaccine have already been completed and further clinical development is currently underway and funded by CEPI (Coalition for Epidemic Preparedness Innovations).
Prof. Marylyn Addo from University Medical Center Hamburg-Eppendorf (UKE) will lead the clinical trials. “Our experiences from the MVA-MERS trials now serve as blueprints for several procedures in this development process and the regulatory procedures required for clinical trials on this new vaccine are already in preparation. Official recruitment of volunteers may only begin after approval has been granted from the Ethics Committee. However, interested people can register now via email at info-covid@uke.de,” says Addo.
Prof. Marylyn Addo contributed substantially to the development of the Ebola and MERS vaccines (DZIF press release of 21 April 2020). The vaccine against MERS coronavirus demonstrated very good tolerability and vaccinees developed immune responses against the virus, which exists in Saudi Arabia and is transmitted from dromedaries to humans.
Background
In order for a vaccine to be effective against SARS-CoV-2, it essentially needs to contain specific parts of the virus against which the human body can develop antibodies. The scientists consequently selected a spike protein found on the surface of the virus to serve as a suitable coronavirus building block. The virus uses this protein to penetrate human cells. The corresponding gene sequence, i.e. the building plan of the spike protein, was combined with genetic information of the MVA vector to result in a viral vector which, when administered as a vaccine, is able to penetrate human cells and synthesise the spike proteins. These are subsequently identified as “foreign” by the immune system, which stimulates an immune response and a production of specific antibodies and T cells against the spike proteins. This in turn can effectively prevent infection by the virus at a later stage.
BSL-4 laboratory in Marburg
Marburg University is one of only four sites in Germany that have a laboratory with the highest biosafety levels (BSL-4). This biosafety level is necessary for working with highly pathogenic viruses like the Ebola virus. Marburg University is and was substantially involved in vaccine research on Ebola, swine flu and the current clinical tests on MERS coronavirus. The university is a member of the DZIF.
