Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S

MERS (Middle East Respiratory Syndrome) Clinical Trial

Official title: An Open, Single Center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 12 months (+/- 4 months) after prime immunization. ;

Related Conditions & MeSH terms

• Coronavirus Infections
• MERS (Middle East Respiratory Syndrome)

• NCT number: NCT03615911
• Study type: Interventional
• Source: Universitätsklinikum Hamburg-Eppendorf
• Status: Completed
• Phase: Phase 1
• Start date: November 28, 2017
• Completion date: May 10, 2019