In addition to the SARS coronavirus-2 that is currently prevalent worldwide, scientists continue to keep an eye on the related MERS coronavirus, as it, too, could potentially become a supra-regional health hazard in the future. For a number of years, in a collaboration between the German Center for Infection Research (DZIF) and the IDT Biologika GmbH, a MERS corona virus vaccine has been developed, the planned international phase-Ib study of which can now begin at the University Hospital Hamburg-Eppendorf (UKE).
“Continuing with the development of a MERS vaccine is an important step, even in times of SARS-COV-2,” explains Principal Investigator Prof. Marylyn Addo, Head of the Division of Infectious Diseases and a scientist at the DZIF. She adds: “If we have learned anything from the current pandemic, it is that we cannot prepare early enough for emerging viruses.“ The MVA-MERS-S vaccine had already proven to be well tolerated in a first clinical pilot study on 23 subjects last year, triggering a persistent antibody formation. The randomized, placebo-controlled phase Ib trial now starts, aiming to test the vaccine in a total of 145 people.
MERS – from dromedary camels to humans
The MERS coronavirus, first detected in 2012, belongs to a list of pathogens classified as particularly dangerous for public health by the World Health Organization. It is transmitted to humans from dromedary camels and can be passed on from human to human. The infection causes respiratory disease that is fatal in up to 35% of cases. Across the world, more than 2.500 MERS cases have been confirmed in 27 countries, with a focus in Saudi Arabia (MERS stands for Middle East Respiratory Syndrome), where the carrier camels are kept as domesticated animals. To date, there is no effective approved vaccine and no specifically-acting drug against the MERS coronavirus.
The vaccine candidate MVA-MERS-S
To be prepared for larger outbreaks, the DZIF scientists began as already in 2014 with the development of a vaccine against the MERS coronavirus. It is based on an attenuated virus (MVA: Modified Vaccinia Ankara) that was already used in the vaccination campaign to eradicate smallpox and has thus been well tested. Antigen components of the MERS coronavirus were incorporated into the virus. This recombinant, vector-based vaccine, known scientifically as MVA-MERS-S, is intended to boost the defence against the MERS coronaviruses. Prof. Gerd Sutter (Ludwig Maximilian University of Munich) developed the vector at the DZIF in collaboration with the team led by Prof. Stephan Becker (Philipps University of Marburg).
The phase Ib vaccine study
The vaccine study that is now starting will be carried out at the UKE in Hamburg in collaboration with the Clinical Trial Center North (CTC North) and at the Erasmus Medical Center in Rotterdam. In total, ten probands receive the vaccine in the first open-label run-in phase of the study, with 135 more subjects being vaccinated subsequently. The core study is placebo-controlled and double-blind and investigates different dose levels and intervals. It is intended to provide information on safety and tolerability on the one hand, and on the other to determine the MERS-CoV-specific immune response. Are sufficient antibodies and T-cells produced to protect against an infection with the MERS coronavirus and to slow down the course of the disease? These tests are conducted at the University of Marburg under the supervision of Professor Stephan Becker, coordinator of the DZIF research area “Emerging Infections” and a key player in all vaccine projects.
In coalition for the vaccine
The international vaccine initiative CEPI (Coalition for Epidemic Preparedness Innovations) supports the development of the vaccine against the MERS coronavirus with up to $36 million. IDT Biologika has taken on this contract and is advancing the development working with a consortium of scientists and physicians, in addition to the DZIF also with participation by the Viroscience Department at the Erasmus Medical Center and the Clinical Research Organisation CR20. The company developed its own cell line and the technology for the large-scale production of the vaccine. Scientists use the same viral vaccine vector (MVA) for the development of a new SARS-CoV-2 vaccine, also in collaboration between the DZIF and IDT Biologika.
Study participation still possible
The study is actively recruiting healthy study participants for the current MERS vaccination study in Hamburg. Both women and men between the ages of 18 and 55 years are eligible. The study is carried out at the UKE in collaboration with the Clinical Trial Center North and comprises eight outpatient visits over a period of seven months. Participation is permitted for people who are already vaccinated against SARS-COV-2 or who are plannimgto be vaccinated. If you are interested, please contact us at: firstname.lastname@example.org