Vaccine Info

MVA MERS-S Vaccine

MVA-MERS-S Vaccine Description

MVA-MERS-S (Modified Vaccinia virus Ankara) is a vaccine candidate that contains the full-length spike gene of MERS-CoV.

The vaccine is based on an attenuated virus, MVA, which had previously been used in a smallpox eradication vaccination campaign and has now been altered to contain protein components from the MERS coronavirus. This recombinant, so-called vector-based vaccine, scientifically termed MVA-MERS-S for short, is to boost immunity against MERS coronaviruses.

MVA-MERS vaccines were produced with tPA, but either the mH5 or F11 promoter driving expression of the spike gene.

Scientists at the University Medical Center Hamburg-Eppendorf and the German Center for Infection Research (DZIF) have now conducted a first-in-human trial with a vaccine against MERS.

The MVA-MERS-S vaccine had a favorable safety profile without serious or severe adverse events. Homologous prime-boost immunization induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses. The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development.

A phase Ib trial, funded by the Coalition for Epidemic preparedness Innovation, is planned in which the vaccine will be tested in 160 trial subjects in Hamburg and Rotterdam, Germany.

The German Center for Infection Research (DZIF), jointly developing new approaches to prevent, diagnose, and treat infectious diseases.

MVA-MERS-S Vaccine Indication

MVA-MERS-S is a vaccine candidate to treat the MERS, which causes a respiratory disease with a case fatality rate of up to 35%. Given its potential to cause a public health emergency and the absence of efficacious drugs or vaccines, MERS is one of the WHO priority diseases warranting urgent research and development of countermeasures.

MVA MERS-S Vaccine Dosage

For the prime immunization, participants received doses of 1 × 107 plaque-forming unit (PFU; low-dose group) or 1 × 108 PFU (high-dose group) MVA-MERS-S intramuscularly. A second identical dose was administered intramuscularly as a booster immunization 28 days after the first injection.

  • 12 participants will receive 10^7 plaque-forming units (PFU) of MVA-MERS-S on days 0 and 28.
  • 12 participants will receive 10^8 PFU of MVA-MERS-S on days 0 and 28.

MVA MERS-S Vaccine News

  • April 21, 2020 - Promising MERS coronavirus vaccine trial on humans – useful insights for vaccine development against SARS-CoV-2.
  • April 20, 2020 - The Lancet published a study that found vaccination with MVA-MERS-S had a favorable safety profile without serious or severe adverse events.
  • April 20, 2020 - Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for the Middle East respiratory syndrome: an open-label, phase 1 trial.
  • October 3, 2013 - MERS Coronavirus Spike Protein Delivered by Modified Vaccinia Virus Ankara Efficiently Induces Virus-Neutralizing Antibodies.

MVA MERS-S Vaccine Clinical Trials

Clinical Trial NCT04119440: Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety and Immunogenicity of MVA-MERS-S_DF-1 (Not yet recruiting)

This will be a Phase Ib, a two-center study in approximately 160 healthy adults aged 18-55 years. The study is separated into two parts

  • Part A
    • The study starts with a single-center open-label run-in phase of two dose levels (cohort 1 "low dose": 2x10^7 PFU, cohort 2 "high dose": 2x10^8 PFU) in 10 healthy subjects. 5 subjects will be allocated to each dose cohort and will receive immunization on day 0 and day 28.
  • Part B
    • Two-center, randomized, double-blind, placebo-controlled, dose-finding study. This part is a double-blinded trial in approximately 150 healthy subjects. Subjects will be allocated to two different dose cohorts and a placebo cohort; each receiving three vaccine injections.

Clinical Trial NCT03615911: Safety, Tolerability, and Immunogenicity of Vaccine Candidate MVA-MERS-S - UPDATE: April 20, 2020- In the German trial, researchers gave 23 participants 18 to 55 years old two low or high doses of modified vaccinia virus Ankara (MVA)-MERS-S vaccine 28 days apart from December  17, 2017, to June 5, 2018. Six healthy, unvaccinated adults served as controls for immunogenicity analyses.

Vaccination with MVA-MERS-S had a favorable safety profile without serious or severe adverse events. Homologous prime-boost immunization induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.

The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development.

  • The Middle East Respiratory Syndrome Coronavirus is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Health Organization and currently without registered prevention or treatment option.
  • In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will additionally receive a late booster vaccination.
  • The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.
  • The vaccine contains a Modified Vaccinia Virus Ankara vector expressing the MERS-CoV spike glycoprotein (S). A total of 24 participants will receive the following vaccine regime:
    • 12 participants will receive 10^7 plaque-forming units (PFU) of MVA-MERS-S on days 0 and 28.
    • 12 participants will receive 10^8 PFU of MVA-MERS-S on days 0 and 28.
    • Safety and immunogenicity data will be collected throughout the study, which concludes at day 180.
Updated
08/24/2020 - 06:45