COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04569383

Marylyn M Addo, MD

m.addo@uke.de

2020-09-29

Completed

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: written informed consent healthy male and female adults aged 18-55 years no clinically significant health problems as determined during medical history and physical examination at screening visit body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening adults male or non-pregnant, non-lactating female with negative pregnancy test males and females who agree to comply with the applicable contraceptive requirements of the protocol inclusion criteria for the subjects before the 3rd/4th (=booster) vaccination: ability to understand the subject information and to personally name, sign and date the in-formed consent to participate in the study. provided written informed consent. continues to be in stable health condition as determined during medical history and physi-cal examination on vaccination visits. non-pregnant, non-lactating female with a negative pregnancy test at screening and on dosing days (prior to vaccination). be willing to refrain from blood donation during the course of the study. the subject is co-operative and available for the entire study. need to have participated in previous part of the mva-sars-2-s vaccine study (eudra-ct no: 2020-002998-10)

prior exposure to sars-cov-2 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 known allergy to the components of the sars-cov-2 vaccine product known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine 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 clinically relevant findings in ecg any confirmed or suspected immunosuppressive or immunodeficient 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 exclusion criteria for the subjects before the 3rd/4th (=booster) vaccination: prior infection with sars-cov-2 in medical history (documented by pcr test) receipt of any vaccine from 2 weeks prior to each trial vaccination (4 weeks for live vac-cines) to 2 weeks after each trial vaccination. receipt any covid-19 vaccine (investigational or licensed other than mva-sars-2-s be-fore vaccination throughout end of study). known allergy to the components of t comirnaty®. known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine. participation in a clinical trial other than the mva-sars-2-s vaccine trial or use of an in-vestigational product other than mva-sars-2-s within 30 days or five times the half-life of the investigational product -whichever is longer- prior to receiving the first dose within this study. evidence in the subject's medical history or in the medical examination that might influence

2

Universitätsklinikum Hamburg-Eppendorf

18

55

Germany

Healthy volunteers

N/A

30

Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol

None

Phase 1

[{"arm_notes": "1x10E7;2;days0-28;additional heterologous booster doses with Comirnaty 21 day interval", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1x10E8;2;days0-28;additional heterologous booster doses with Comirnaty 21 day interval", "treatment_id": 839, "treatment_name": "Mva-sars-2-s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]