Vaccine Info

MVA MERS-S Vaccine

MVA-MERS-S Vaccine Description

MVA-MERS (Modified Vaccinia virus Ankara) is a vaccine candidate that contains the full-length spike gene of MERS-CoV. MVA-MERS vaccines were produced with tPA, but either the mH5 or F11 promoter driving expression of the spike gene

MVA-MERS-S Vaccine Indication

MVA-MERS-S is a vaccine candidate to treat the Middle East respiratory syndrome (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 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. 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.
  • 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 (MERS-CoV) is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Health Organization (WHO) 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 (MVA) 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.

Update March 2019: A subgroup of participants from both dose cohorts will receive a late booster immunization of 10^8 PFU MVA-MERS-S 9 months (+/- 4 months) after prime immunization.

 

Updated
04/28/2020 - 12:44