COVID-19 vaccine is being tested
Experts repeatedly point out that the corona pandemic will not be over until the SARS-CoV-2 coronavirus vaccines become available. Corona vaccines are currently the subject of research around the world. One of them can now be tested on people in Germany.
In Germany, the clinical trial with a vaccine against COVID-19 has been approved. Vaccinations are expected to start this month. (Image: Alernon77 / stock.adobe.com)
The danger posed by the SARS-CoV-2 coronavirus will only be avoided when a vaccination against the new pathogen becomes available. Researchers around the world are working on vaccines. Another German candidate will soon be tested on humans.
Approved clinical trial
According to a recent announcement from the German Infection Research Center (DZIF), the Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedical Medicines, has approved the clinical trial with the MVA-SARS-2-S vaccine against COVID- 19.
The vector vaccine was developed by scientists at DZIF and IDT Biologika GmbH and is currently being examined in the first clinical phase for its safety, tolerability and specific immune response to the new pathogen.
The clinical study is scheduled to begin in October with the recruitment of the first of a total of 30 study participants to the CTC North medical contract institute at the University Medical Center Hamburg-Eppendorf (UKE).
“Have a permanent grip on the virus”
“I congratulate the entire DZIF vaccination team for this rapid development of a promising candidate for a vaccine against SARS-CoV-2,” says Prof. Dr. Hans-Georg Kräusslich, CEO of DZIF.
“We are happy that the first clinical study has now been approved and will start very soon, and of course we hope for good results,” said Kräusslich.
And Katharina Fegebank, the Hamburg senator for science, research, equality and districts, said in a statement from UKE: “I am extremely happy that the scientists in Hamburg can make a decisive contribution to the fight against the pandemic thanks to their exceptional research. One thing is clear: only with excellent research and scientific expertise can we control the virus in the long term.
The vaccine is a vector vaccine developed at the Ludwig Maximilians University in Munich (LMU) against the SARS-CoV-2 coronavirus, in which the genetic information of a surface protein of the SARS-CoV-2 virus is incorporated into the virus modified and therefore harmless smallpox (MVA) is incorporated.
According to reports, this viral vector cannot multiply, but the introduced DNA sequence – the component of the coronavirus – can simulate infection and trigger the production of antibodies and T cells.
“We are pleased with the approval of the Paul Ehrlich Institute. Over the past few months, the vaccine has been developed with our cooperation partner DZIF, Prof. Dr. Gerd Sutter from LMU and Prof. Dr. Stephan Becker from Philipps University in Marburg, who we are currently evaluating for its effectiveness and efficiency. safety, ”explains Professor Dr. Marylyn Addo, UKE infectious disease manager, who is the investigator in charge of the clinical study.
Generated over 30 years ago
The parent virus MVA was generated over 30 years ago at LMU as a safe vaccine against smallpox and has already been used successfully for the development of a vaccine against the MERS coronavirus.
IDT Biologika GmbH, a company that produces biotechnology vaccines and pharmaceuticals, has now developed a cell line and process for the large-scale production of high purity MVA vector vaccines and has already completed the production and filling of doses of vaccine for the first human clinical trial.
Preclinical models from the universities of Marburg and Munich have already shown that the MVA vector vaccine against SARS-CoV-2 exhibits the desired immune responses and a protective effect.
First vaccination scheduled for mid-October
The study will begin in early October with the preliminary examinations and the selection of healthy volunteers and volunteers. The first participant is expected to be vaccinated with the low-dose vaccine in mid-October.
For safety reasons, only one person is vaccinated initially and the next two only 24 hours later. In total, the 30 study participants aged 18 to 55 will be vaccinated in eight groups and in two increasing doses.
Test subjects receive two vaccinations every four weeks and are medically monitored for a few hours at the CTC North after each vaccination.
In the days following vaccination and for the next six months, vaccinees should attend regular outpatient examinations to check the tolerance of the vaccine, possible side effects and the immune response based on blood tests and surveys.
Researchers in Prof. Addo’s working group and partner DZIF in Marburg simultaneously measure the formation of antibodies and T cells in the body and compare them to the immune response of recovered COVID-19 patients.
“A larger phase II clinical trial is planned for the end of the year, when the results of the phase I study show a good safety profile and good immune responses induced by the vaccine. In this phase of the study, we will include other test subjects, including elderly people, in the tests, ”explains Professor Addo.
According to the information, in addition to UKE, university clinics in Tübingen, Marburg and Munich as well as other partner institutions will be involved in these phase II studies. (a d)
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