Status:
COMPLETED
Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Coalition for Epidemic Preparedness Innovations
IDT Biologika Dessau.Rossau
Conditions:
MERS (Middle East Respiratory Syndrome)
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Detailed Description
This will be a Phase Ib, two-center study in approximately 160 healthy adults aged 18-55 years The study is separated in two parts: Part A: The study starts with a single center open-label run-in p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04119440
Start Date
April 16 2021
End Date
November 6 2024
Last Update
April 24 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
2
Erasmus Medical Centre
Rotterdam, Rotterdam, Netherlands, 3015