The MVA-MERS-S-Phase1b trial is a two-center, randomized, double-blind, placebo-controlled, phase Ib study to assess the safety, tolerability and immunogenicity of two ascending doses of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects.

The vaccine study is carried out at the UKE in Hamburg in collaboration with the Erasmus Medical Center in Rotterdam .

The MVA-MERS-S-Phase1b trial with 145 subjects has been completed with promising results which will soon be published. Currently a longterm follow up is ongoing to determine the 24 month durability of the vaccine-induced immune response. A few years ago tthe MVA-MERS-S vaccine had already proven to be well tolerated in a first clinical pilot study on 23 subjects, triggering a persistent antibody formation.

The international vaccine initiative CEPI (Coalition for Epidemic Preparedness Innovations) supports the development of the vaccine against the MERS coronavirus.

The MERS coronavirus vaccine has been developed in a collaboration between the German Center for Infection Research ( DZIF ) and the IDT Biologika GmbH . It is based on an attenuated viral vector (MVA: Modified Vaccinia Ankara). The Spike-Antigen of the MERS coronavirus was incorporated into the viral vector. This recombinant, vector-based vaccine, is intended to induce immunity against the MERS coronavirus. 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).

clinicaltrial.gov

Publications

Harrer CE, Mayer L, Fathi A, Lassen S, Ly ML, Zinser ME, Wolf T, Becker S, Sutter G, Dahlke C, Addo MM; MVA-MERS-S Study Group. Identification of a spike-specific CD8+ T cell epitope following vaccination against the Middle East respiratory syndrome coronavirus in humans. J Infect Dis. 2024 Jan 9:jiad612. doi: 10.1093/infdis/jiad612. Epub ahead of print. PMID: 38195212. Link

Raadsen MP, Dahlke C, Fathi A, Lamers MM, van den Doel P, Zaeck LM, van Royen ME, de Bruin E, Sikkema R, Koopmans M, van Gorp ECM, Sutter G, de Vries RD, Addo MM, Haagmans BL. Monkeypox Virus Cross-Neutralizing Antibodies in Clinical Trial Participants Vaccinated With Modified Vaccinia Virus Ankara Encoding Middle East Respiratory Syndrome-Coronavirus Spike Protein. J Infect Dis. 2023 Aug 31;228(5):586-590. doi: 10.1093/infdis/jiad052. PMID: 36857443 Link

Weskamm LM, Fathi A, Raadsen MP, Mykytyn AZ, Koch T, Spohn M, Friedrich M; MVA-MERS-S Study Group; Haagmans BL, Becker S, Sutter G, Dahlke C, Addo MM. Persistence of MERS-CoV-spike-specific B cells and antibodies after late third immunization with the MVA-MERS-S vaccine. Cell Rep Med. 2022 Jul 19;3(7):100685. doi: 10.1016/j.xcrm.2022.100685. PMID: 35858586 Link

Fathi A, Dahlke C, Krähling V, Kupke A, Okba NMA, Raadsen MP, Heidepriem J, Müller MA, Paris G, Lassen S, Klüver M, Volz A, Koch T, Ly ML, Friedrich M, Fux R, Tscherne A, Kalodimou G, Schmiedel S, Corman VM, Hesterkamp T, Drosten C, Loeffler FF, Haagmans BL, Sutter G, Becker S, Addo MM. Increased neutralization and IgG epitope identification after MVA-MERS-S booster vaccination against Middle East respiratory syndrome. Nat Commun. 2022 Jul 19;13(1):4182. doi: 10.1038/s41467-022-31557-0. PMID: 35853863 Link

Koch T, Dahlke C, Fathi A, Kupke A, Krähling V, Okba NMA, Halwe S, Rohde C, Eickmann M, Volz A, Hesterkamp T, Jambrecina A, Borregaard S, Ly ML, Zinser ME, Bartels E, Poetsch JSH, Neumann R, Fux R, Schmiedel S, Lohse AW, Haagmans BL, Sutter G, Becker S, Addo MM. Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial. Lancet Infect Dis. 2020 Jul;20(7):827-838. doi: 10.1016/S1473-3099(20)30248-6. Epub 2020 Apr 21. PMID: 32325037 Link