The Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedical Medicines, has approved another phase 1 clinical trial of a vaccine against COVID-19 in Germany. The current vaccine candidate is a so-called vector vaccine. The testing of vaccine candidates in humans is a significant step on the way to the approval of safe and effective vaccines against COVID-19.
Electron microscope image SARS-CoV-2
The current vaccine is a vector vaccine against the SARS-CoV-2 coronavirus developed by the German Center for Infection Research (DZIF) and IDT Biologika GmbH. In this vector vaccine, the genetic information for the spike surface protein of SARS-CoV-2 is built into the genetic information of the smallpox vaccine virus MVA. The parent vaccine virus MVA was developed more than 30 years ago at the Ludwig Maximilians University of Munich (LMU) and the approved smallpox vaccine Imvanex was also derived from it. The viral vector MVA, which is equipped with the genetic information of SARS-CoV-2, cannot multiply in the body after injection. The introduced genetic information (DNA, deoxyribonucleic acid) of the SARS-CoV-2 spike protein is used in the body to build the spike protein. The immune system recognizes the foreign spike protein and triggers an immune response. The aim is to develop antibodies, certain cytokines and immune cells (T cells) for sustained protection against SARS-CoV-2. Preclinical models from the Universities of Marburg and Munich have already shown that the MVA vector vaccine against SARS-CoV-2 shows the desired immune responses and a protective effect.
The clinical trial approved by the Paul Ehrlich Institute on September 30, 2020 is a phase 1 trial with a total of 30 healthy adult volunteers aged 18 to 55 years. The study participants receive two vaccinations four weeks apart. The working group at the University Medical Center Hamburg-Eppendorf (UKE) and the DZIF partner in Marburg are simultaneously measuring the formation of antibodies and T cells in the body and comparing them with the immune response of recovered COVID-19 patients. The UKE is responsible for the clinical trial, which is carried out together with the contracted medical institute CTC North. The study is financed by public funds from the DZIF.
As of September 30, 2020, the vaccine candidate is one of 41 preventive, specific COVID-19 vaccine candidates worldwide that are being evaluated in clinical trials, according to the World Health Organization. In Germany, this is the first approved phase 1 clinical trial of a vector-based COVID-19 vaccine. The growing number of clinical trials around the world is an important step towards the approval of safe and effective COVID-19 vaccine products.
The Paul Ehrlich Institute, which is responsible for the approval of clinical trials as well as the evaluation and approval of vaccines in Germany, expects that further clinical trials of COVID-19 vaccine candidates will begin in Germany in the next few months. The Paul Ehrlich Institute supports the worldwide COVID-19 vaccine development with the highest priority.
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