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

NCT03615911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-10-06

Study results available
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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.

Conditions

  • MERS (Middle East Respiratory Syndrome)

Interventions

BIOLOGICAL

vaccine candidate MVA-MERS-S

vaccination with MVA-MERS-S in two escalating dose regimes

Sponsors & Collaborators

  • Philipps University Marburg

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Bernhard Nocht Institute for Tropical Medicine

    collaborator OTHER_GOV

  • University of Cologne

    collaborator OTHER

  • Marylyn Addo

    lead OTHER

Principal Investigators

  • Marylyn M Addo, Prof. Dr. · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2019-04-15
Completion
2019-05-10

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615911 on ClinicalTrials.gov