Status:
COMPLETED
Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
German Center for Infection Research
Philipps University Marburg
Conditions:
Covid19
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B).
Detailed Description
The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing a stabilized SARS-CoV-2 spike protein (S). This will be a phase Ib multi-center study in approximately 60 adults aged 18-...
Eligibility Criteria
Inclusion
- Written informed consent.
- Healthy male and female adults aged 18 - 64 at time of informed consent.
- Body mass index 18.5 - 32.0 kg/m2 and weight \> 50 kg at screening.
- Female participants: non-pregnant, non-lactating with negative pregnancy test.
- Females who agree to comply with the applicable contraceptive requirements of the protocol.
- ≥ 6 months fully vaccinated with a (conditionally)licensed mRNA vaccine against COVID-19 (Part B only)
Exclusion
- Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
- Previous rMVA immunization.
- Previous immunization with investigational vaccine against COVID-19.
- Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to Part B).
- Evidence of active SARS-CoV-2 infection
- Known allergy to the components of the MVA-SARS-2-ST vaccine product or history of life-threatening reactions to vaccine containing the same substances.
- Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
- Evidence in the participant's medical history or in the medical examination that might influence either the safety of the participant or the absorption, distribution, metabolism or excretion of the investigational product.
- Clinically relevant findings in ECG or significant thromboembolic events in medical history.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
- Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
Key Trial Info
Start Date :
July 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04895449
Start Date
July 16 2021
End Date
November 8 2022
Last Update
January 18 2023
Active Locations (2)
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1
Uniklinik Köln
Cologne, North Rhine-Westphalia, Germany, 50937
2
CTC North
Hamburg, Germany, 20251