Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS
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
1 other identifier
interventional
145
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2021
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedStudy Start
First participant enrolled
April 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2024
CompletedApril 24, 2025
April 1, 2025
1.6 years
October 6, 2019
April 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Immunogenicity
day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)
Study Arms (3)
Low Dose
EXPERIMENTALVaccination with 2x10\^7 PFU MVA-MERS-S\_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
High Dose
EXPERIMENTALVaccination with 2x10\^8 PFU MVA-MERS-S\_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
Placebo
PLACEBO COMPARATORInjection with placebo. Injections will be administered at days 0, 28 or 56, and 336.
Interventions
Administrations of the low dose via the intramuscular route
Administrations of the high dose via the intramuscular route
Eligibility Criteria
You may qualify if:
- Written informed consent form.
- Healthy male and female subjects aged 18-55 years.
- No clinically significant acute health problems as determined from medical history and physical examination at screening visit.
- Body mass index 18.5 - 30.0 kg/m2 and weight \> 50 kg at screening.
- Non-pregnant, non-lactating female with negative pregnancy test.
- Males and females who agree to comply with the applicable contraceptive requirements of the protocol.
You may not qualify if:
- Receipt of any vaccine from 2 weeks prior to each trial vac-cination (4 weeks for live vaccines) to 3 weeks after each trial vaccination.
- Receipt of vaccination against MERS or MVA immunizations.in the medical history.
- Known allergy to the components of the MVA-MERS-S\_DF-1 vaccine product.
- Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product.
- Any confirmed or suspected immunosuppressive or immuno-deficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.
- Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsklinikum Hamburg-Eppendorflead
- Coalition for Epidemic Preparedness Innovationscollaborator
- IDT Biologika Dessau.Rossaucollaborator
- German Center for Infection Researchcollaborator
- CR2Ocollaborator
- Erasmus Medical Centercollaborator
- Monipol Deutschland GmbHcollaborator
Study Sites (2)
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Erasmus Medical Centre
Rotterdam, Rotterdam, 3015, Netherlands
Related Publications (1)
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.
PMID: 39389076DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blinded
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2019
First Posted
October 8, 2019
Study Start
April 16, 2021
Primary Completion
November 28, 2022
Study Completion
November 6, 2024
Last Updated
April 24, 2025
Record last verified: 2025-04