v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04895449 |
|
Full text link
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 23, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 23, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
not reported |
|
Registration date
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-20 |
|
Recruitment status
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
nonRCT |
|
Allocation
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
inclusion criteria: 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 criteria
Last imported at : Dec. 1, 2021, 11 p.m. 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. 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. |
|
Number of arms
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
6 |
|
Funding
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Universitätsklinikum Hamburg-Eppendorf |
|
Inclusion age min
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Germany |
|
Type of patients
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
43 |
|
primary outcome
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol |
|
Notes
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Dec. 1, 2021, 11 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "\u2265 1 x 10E7 IU (low dose);2;days0-28; seronegative", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\u2265 5 x 10E7 IU (middle dose);2;days0-28; seronegative", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\u2265 1 x 10E8 IU (high dose);2;days0-28; seronegative", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\u2265 1 x 10E7 IU (low dose);1;mRNA vaccinated subjects", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\u2265 5 x 10E7 IU (middle dose);1;mRNA vaccinated subjects", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "\u2265 1 x 10E8 IU (high dose);1;mRNA vaccinated subjects", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |