MVA-MERS-S
A Two-center, Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S_DF-1 in Healthy Study Subjects
Sponsor study identifier
interventional
145
2 countries
2
Study Start
April 16, 2021
Actual (reported)Primary Completion
November 28, 2022
Actual (reported)Study Completion
November 6, 2024
Actual (reported)The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S\_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S\_DF-1 the data will be compared to a placebo control group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 6, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 6, 2019
Actual (reported)October 8, 2019
Actual (reported)April 16, 2021
Actual (reported)November 28, 2022
Actual (reported)November 6, 2024
Actual (reported)Frequency of adverse events associated with MVA-MERS-S_DF-1.
Safety and reactogenicity will be assesssed by observation, questionaire and diary. Changes from baseline for safety laboratory measures will be monitored. Occurence of SAE will be collected throughout the entire study duration.
day 1, 14, 29, 42, 56, 84, 168, 336, 364
Frequency and severity of local injection site reactogenicity signs and symptoms
day 1, 14, 29, 42, 84, 336
Immunogenicity
day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)
Vaccination with 2x10\^7 PFU MVA-MERS-S\_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
Vaccination with 2x10\^8 PFU MVA-MERS-S\_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336.
Administrations of the low dose via the intramuscular route
Administrations of the high dose via the intramuscular route
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Erasmus Medical Centre
Rotterdam, Rotterdam, 3015, Netherlands
Raadsen MP, Dahlke C, Fathi A, Hardtke S, Kluver M, Krahling V, Gerresheim GK, Mayer L, Mykytyn AZ, Weskamm LM, Zoran T, van Gorp ECM, Sutter G, Becker S, Haagmans BL, Addo MM; MVA-MERS-S_DF-1 Study group. Safety, immunogenicity, and optimal dosing of a modified vaccinia Ankara-based vaccine against MERS-CoV in healthy adults: a phase 1b, double-blind, randomised placebo-controlled clinical trial. Lancet Infect Dis. 2025 Feb;25(2):231-242. doi: 10.1016/S1473-3099(24)00423-7. Epub 2024 Oct 7.
145 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2019
First Posted
October 8, 2019
Study Start
April 16, 2021
Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease
Administrations of placebo via the intramuscular route
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 28, 2022
Actual (reported)Study Completion
November 6, 2024
Actual (reported)Last Updated
April 24, 2025
Record last verified: 2025-04
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Source: ClinicalTrials.gov.
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