NCT03615911

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Marylyn Addo · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• MERS (Middle East Respiratory Syndrome)

Interventions

Type	Name	Description
BIOLOGICAL	vaccine candidate MVA-MERS-S	vaccination with MVA-MERS-S in two escalating dose regimes

Timeline

• Start date: 2017-11-28
• Primary completion: 2019-04-15
• Completion: 2019-05-10
• First posted: 2018-08-06
• Last updated: 2020-10-06
• Results posted: 2020-10-06

Locations

1 site across 1 country: Germany