Clinical trials for vaccine against SARS-CoV-2 can begin in September
18.05.2020 12:27
A potential vaccine against SARS-CoV-2 is scheduled to be tested in initial human clinical trials before the end of this year. "The blueprint for the vaccine is complete. Now the vaccine needs to be produced for clinical trials," 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 Center for Infection Research (DZIF).
He adds: "We now have everything financially and logistically in place to begin a Phase I clinical trial soon." This phase involves testing for tolerability and stimulating immune responses. Immune monitoring—that is, characterizing the antibody response to the vaccine—is taking place in Marburg.
Vaccine approval „cannot happen in a few weeks“
The vaccine for clinical phase I is currently being manufactured by IDT Biologika in Dessau. Production is expected to be completed in three months, allowing clinical trials to begin in September. Although development is proceeding much faster than previous processes, no vaccine will be available this year. "Vaccine development is a lengthy, arduous process, especially the clinical trials for approval of a candidate. That can't be completed in a few weeks," Becker emphasizes.
The vaccine candidate now awaiting Phase I clinical trials was developed under the direction of Prof. Dr. Gerd Sutter of LMU Munich. It is a so-called vector vaccine based on the "modified vaccinia Ankara" (MVA) vector. The MVA vaccine virus was generated at LMU Munich more than 30 years ago as a smallpox vaccine. The MVA viruses are so weakened that they can serve as harmless vectors for other vaccines.
„"This gives us a platform technology that allows us to, in principle, place any foreign genetic information under the control of our vaccine virus. It is a proven vector system for which large-scale production is already established. The base virus is fully characterized and, together with genetically modified variants, has now been clinically tested on more than 12,000 individuals. We already have a very good understanding of the side effect profile and immunogenicity of the base vaccine," emphasizes Gerd Sutter. At the DZIF, this vector has already been successfully used to develop a vaccine against the MERS coronavirus, a close relative of SARS-CoV-2; the first clinical trial of this MERS vaccine has already been completed, and further clinical development is currently underway under funding from CEPI (Coalition for Epidemic Preparedness Innovations).
The clinical trial will be led by Prof. Marylyn Addo of the University Medical Center Hamburg-Eppendorf (UKE). "The experiences from the MVA-MERS study can serve as a blueprint for many processes in this development process. Regulatory preparations for the clinical trial of the new vaccine have already begun. Official recruitment of volunteers can only begin after the ethics committee has given its approval, but interested parties can already register by email," says Addo.
Prof. Marylyn Addo has already played a key role in the development of the Ebola and MERS vaccines (DZIF press release of April 21, 2020). The vaccine against the MERS coronavirus showed excellent tolerability. Vaccinated individuals developed an immune response against the MERS coronavirus, which is found in Saudi Arabia and is transmitted from dromedary camels to humans.