For the global population, a SARS-CoV-2 vaccine would be a salvation. Healthcare experts from Central Hessen have again come a step closer to this goal, with clinical testing on humans.
Worldwide, the development of a vaccine against SARS-CoV-2 is in full swing. In Central Hessen, too, the next stage of development has begun: The first clinical trials on humans will already begin in September. “The construction plan for the vaccine is ready. Now the vaccine still has to be produced for the clinical tests,” explains Prof. Dr. Stephan Becker, head of the Institute of Virology at the University of Marburg and coordinator of the Emerging Infectious Diseases division at the German Centre for Infection Research (DZIF). “Financially and logistically, everything is in place for the start of the phase 1 clinical trial,”says Becker. In this phase, the focus is not only on the tolerability of the vaccine candidate, but also on the human immune response: This so-called immune monitoring – the characterisation of the antibody response – will take place in Marburg. The vaccine quantities required for the clinical phase 1 are produced by IDT Biologika in Dessau, Germany. Production is expected to be completed in the next three months, so that clinical trials can begin in September.
Viruses as vaccine ferries
The so-called vector vaccine was developed by researchers at the Ludwig Maximilian University in Munich (LMU) under the direction of Prof. Dr. Gerd Sutter. These vectors are attenuated viruses that can be used as harmless transport vehicles. Sutter’s team uses the Modified Vaccinia Ankara Virus (MVA), which was produced at the LMU more than 30 years ago – at that time, for vaccination purposes against smallpox. In the race to find a vaccine, this is a big advantage: “This gives us a platform technology, and, in principle, we can put any foreign genetic information under the control of our vaccination virus,” says Sutter. “It’s a proven vector system for which large-scale production has already been established. The basic virus has been fully characterized. Together with genetically modified variants, it has also been clinically tested on more than 12,000 people. We already know the side effect profile and immunogenicity of the basic vaccine very well,” Sutter adds.
Benefiting from the knowledge about the MERS vaccine
The DZIF experts also have experience with vaccine viruses: These have already been successfully used as vectors for the development of vaccines against the MERS coronavirus, which occurs in Saudi Arabia and is transmitted from dromedaries to humans. As a close relative of SARS-CoV-2, the MERS coronavirus vaccine has already successfully completed its first clinical trial and is currently in further development. Prof. Marylyn Addo from the University Medical Center Hamburg-Eppendorf (UKE) is leading the clinical trial for the new vaccine candidate against SARS-CoV-2. “For many procedures in this development process, the experience from the MVA-MERS study can serve as a blueprint,” says Addo, who has already played a major role in the development of the MERS vaccine. It was found that the vaccine against the MERS coronavirus is very well tolerated, and the vaccinated individuals showed an immune response.
In spite of turbo development – No vaccine in 2020
Addo adds that regulatory preparations for clinical trials of the new vaccine have also already begun. “The official recruitment of volunteers can only take place after the ethics committee has given a positive vote, but interested parties can already register now – at the e-mail address: firstname.lastname@example.org,” she adds. Although the development of the vaccine is much faster compared to earlier procedures, the researchers are conservative in their outlook: This year, the vaccine will not yet be available. Vaccine development remains a long and arduous process. “In particular, the clinical trial for the approval of a vaccine candidate takes longer than a few weeks,” says Becker. A vaccine against coronavirus is highly likely, then; the question is, rather, when will it be ready for wide-spread use.