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| Column | Value |
|---|---|
| Trial registration number | NCT05950776 |
|
Full text link
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
|
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Contact
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
2023-07-18 |
|
Recruitment status
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: written informed consent. male and female adults in stable health conditions aged 18 - 64 at time of informed consent (participation of health care workers and risk groups will be prioritized) and male or female in stable health conditions aged ≥ 65 at time of informed consent. either in good or stable health in the opinion of the investigator. participants may have underlying illness as long as their symptoms are medically controlled, and they are on a stable medication for the respective underlying illness for at least 8 weeks before screening and no changes are expected during the study. body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening. non-pregnant, non-lactating female with negative pregnancy test. females who agree to comply with the applicable contraceptive requirements of the protocol. |
|
Exclusion criteria
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
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. evidence of an active sars-cov-2 infection. known allergy to the components of the mva-sars-2-s vaccine product such as chicken proteins, 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 vaccine. 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 under investigation. 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. |
|
Number of arms
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Universitätsklinikum Hamburg-Eppendorf |
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Inclusion age min
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol |
|
Notes
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : July 19, 2023, noon Source : ClinicalTrials.gov |
[{"arm_notes": "Low dose", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High dose", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |