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MVA MERS S

Drug Profile

MVA MERS S

Alternative Names: MERS-CoV vaccine - IDT Biologika GmbH/Ludwig-Maximilians-University; Middle East respiratory syndrome coronavirus vaccine - IDT Biologika GmbH/Ludwig-Maximilians-University; MVA-MERS-S

Latest Information Update: 27 Apr 2020

At a glance

  • Originator Ludwig-Maximilians-University
  • Developer Bernhard Nocht Institute for Tropical Medicine; Charite - Universitatsmedizin Berlin; Ludwig-Maximilians-University; University Medical Center Hamburg-Eppendorf; University of Cologne; University of Marburg
  • Class Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I Middle East respiratory syndrome coronavirus

Most Recent Events

  • 21 Apr 2020 Adverse events and immunogenicity data from a phase I trial in Middle East respiratory syndrome coronavirus released by University Medical Center Hamburg-Eppendorf
  • 21 Apr 2020 University Medical Center Hamburg-Eppendorf plans a clinical trial for COVID-2019 infections

Development Overview

Introduction

MVA-MERS-S, a prophylactic Middle East respiratory syndrome coronavirus (MERS-CoV) vaccine, is being developed by MERS-CoV Vaccine Consortium comprising of IDT Biologika GmbH, German Center for Infection Research (DZIF), Erasmus MC and CR2O. The vaccine consists of a recombinant Modified Vaccinia Ankara (MVA) vector with an inserted MERS gene that expresses the MERS-CoV spike glycoprotein (S). The first generation of the MVA MERS vaccine is produced in primary chicken embryo fibroblasts. The vaccine was originally developed by Ludwig-Maximilians University (LMU) in collaboration with Erasmus MC and Phillips University Marburg (University of Marburg in organisation table). Phase I development is underway in Germany.

MVA MERS S was advanced up to phase I development stage by the German Center of Infection Research (DZIF) comprising of University of Marburg, Ludwig-Maximilians University, University Medical Center Hamburg-Eppendorf and Clinical Trial Centre North. Further development will be continued by IDT Biologika GmbH and a MERS-CoV Vaccine Consortium [1] . IDT Biologika GmbH developed a proprietary cell substrate for large-scale production of the MVA-based vaccine produced in primary chicken embryo fibroblasts [2] .

Key Development Milestones

In May 2019, University of Marburg, Ludwig-Maximilians University, University Medical Center Hamburg-Eppendorf, in collaboration with Charite - Universitatsmedizin Berlin (Charite University, Berlin), Bernhard Nocht Institute for Tropical Medicine and University of Cologne completed a phase I trial that evaluated the safety, tolerability and immunogenicity of MVA MERS S in healthy volunteers (UKE-DZIF1-MVA-MERS-S; NCT03615911). The open-label, ascending dose trial was initiated in November 2017 and enrolled 23 volunteers in Germany. In April 2020, German Center for Infection Research announced positive result for the trial. Based on this data German Center for Infection Research plans to develop MVA MERS S vaccine for COVID-2019 infections [3] .

In preclinical trials, MVA MERS S was safe and effective against MERS-CoV infections in genetically modified mice that had been made susceptible to coronavirus infections [4] . Immunisation of BALB/c mice with either intramuscular or subcutaneous regimens of MVA MERS S induced MERS-CoV-specific CD8(+) T cells and virus-neutralizing antibodies. Vaccinated mice were protected against MERS-CoV challenge infection after transduction with the human dipeptidyl peptidase 4 receptor [5] [6] .

Ludwig-Maximilians University, in December 2015, reported that MVA MERS S decreased viral load in camels [7] .

In September 2013, Ludwig-Maximilians University reported that MVA MERS S induced the immune system to develop antibodies that prevent a coronavirus infection in mice [7] .

Financing information

In August 2018, the Coalition for Epidemic Preparedness Innovations (CEPI) reported that IDT Biologika GmbH will receive up to $US36 million to further the development and manufacture of a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Under the Framework Partnering Agreement, CEPI will provide $US15.7 million to support the first stages of the development, with options to invest up to a total of $US36 million over 5 years, including clinical development, process development, manufacturing and stockpile of the vaccine [2] .

Drug Properties & Chemical Synopsis

  • Route of administration IM, SC
  • Formulation Injection
  • Class Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Middle East respiratory syndrome coronavirus - Prevention Phase I Germany IM / Injection Bernhard Nocht Institute for Tropical Medicine, University of Marburg, University of Cologne, University Medical Center Hamburg-Eppendorf, Ludwig-Maximilians-University, Charite - Universitatsmedizin Berlin 27 Nov 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Ludwig-Maximilians-University Originator Germany
Ludwig-Maximilians-University Owner Germany
Coalition for Epidemic Preparedness Innovations Funder Norway
University of Marburg Collaborator Germany
University Medical Center Hamburg-Eppendorf Collaborator Germany
German Center for Infection Research Collaborator Germany
Bernhard Nocht Institute for Tropical Medicine Collaborator Germany
Charite - Universitatsmedizin Berlin Collaborator Germany
University of Cologne Collaborator Germany
Erasmus MC Collaborator Netherlands
IDT Biologika GmbH Collaborator Germany

Scientific Summary

Adverse Events

Phase I:

In a phase I trial, treatment with MVA MERS S vaccine was well tolerated in healthy volunteers [3] .

Immunogenicity

Phase I:

In a phase I trial, treatment with MVA MERS S vaccine activated the development of antibodies and T cell immunity in healthy volunteers [3] .

Development History

Event Date Update Type Comment
21 Apr 2020 Scientific Update Adverse events and immunogenicity data from a phase I trial in Middle East respiratory syndrome coronavirus released by University Medical Center Hamburg-Eppendorf [3] Updated 27 Apr 2020
21 Apr 2020 Trial Update University Medical Center Hamburg-Eppendorf plans a clinical trial for COVID-2019 infections [3] Updated 27 Apr 2020
10 May 2019 Trial Update University Medical Center Hamburg-Eppendorf completes a phase I trial in Middle East respiratory syndrome coronavirus (Prevention) in Germany (IM) (NCT03615911) [3] Updated 27 Apr 2020
27 Nov 2017 Phase Change - I Phase-I clinical trials in Middle East respiratory syndrome coronavirus (Prevention) in Germany (IM) (NCT03615911) Updated 30 Aug 2018
17 Jun 2015 Trial Update Ludwig-Maximilians University plans a phase I trial for Middle East respiratory syndrome coronavirus (Prevention) [4] Updated 30 Aug 2018
06 Sep 2013 Phase Change - Preclinical Preclinical trials in Middle East respiratory syndrome coronavirus in Germany (IM) [7] Updated 30 Aug 2018

References

  1. The development of a vaccine against MERS virus gets international support.

    Media Release
  2. CEPI Awards Contract Worth Up To USD$36 million to Consortium led by IDT to Develop MERS Vaccine.

    Media Release
  3. Promising MERS coronavirus vaccine trial on humans - useful insights for vaccine development against SARS-CoV-2.

    Media Release
  4. MERS coronavirus: vaccine in development.

    Media Release
  5. Protective Efficacy of Recombinant Modified Vaccinia Virus Ankara Delivering Middle East Respiratory Syndrome Coronavirus Spike Glycoprotein

  6. Middle East Respiratory Syndrome Coronavirus Spike Protein Delivered by Modified Vaccinia Virus Ankara Efficiently Induces Virus-Neutralizing Antibodies

  7. First candidate vaccine against new coronavirus.

    Media Release
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