COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04546841

Helmut Salih, Prof. MD

helmut.salih@med.uni-tuebingen.de

2020-09-14

Completed

nonRCT

Non-randomized

Sequential assignment

Open label

single-center

Prevention

inclusion criteria: 1. adult male or non-pregnant, non-lactating female 1. part i: age 18-55 at the time of screening 2. part ii: age 56-74 years at the time of screening 3. part iii: age ≥ 75 years at the time of screening 2. pre-existing medical condition 1. part i and ii: free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening 3. ability to understand and voluntarily sign the informed consent form. 4. ability to adhere to the study visit schedule and other protocol requirements. 5. female with child bearing potential (fcbp) and male volunteers with partners of childbearing potential, who are sexually active must agree to the use of two effective forms (at least one highly effective method) of contraception. this should be started from the signing of the informed consent and continue until three months after vaccination 6. postmenopausal or evidence of non-childbearing status. for women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. postmenopausal or evidence of non-childbearing status is defined as: - amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments - luteinizing hormone (lh) and follicle stimulating hormone (fsh) levels in the post menopausal range for women under 50 7. be willing to minimize blood and body fluid exposure of others for 7 days after vaccination - use of effective barrier prophylaxis, such as latex condoms, during sexual intercourse - avoiding the sharing of needles, razors, or toothbrushes - avoiding open-mouth kissing - refrain from blood donation during the course of the study

pregnant or lactating females. participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint any immunosuppressive treatment except low dose corticosteroids (≤10mg prednisolone/day) prior or current infection with sars-cov-2 tested serologically or by throat/nose swab (pcr) history of guillain-barré syndrome positive serological hiv, hepatitis b or c test. in case of positive hbsag, volunteer must provide prove of hepatitis b vaccination, otherwise volunteer must be excluded. history of relevant central nervous system (cns) pathology or current relevant cns pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child) baseline laboratory with lymphocyte count ≤ 1000/µl only part i and ii: - acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test all parts of the clinical trial diabetes mellitus typ ii requiring drug treatment chronic lung disease requiring drug treatment any chronic liver disease or unknown liver abnormalities defined as: alanin-aminotransferase (alt) and aspartat-aminotransferase (ast) ≤ 2.5 x uln (upper limit of normal) gamma-glutamyl-transferase (γ-gt) ≤ 2.5 x uln chronic renal failure defined as glomerular filtration rate (gfr) < 40 ml/min/1,73m2 serious pre-existing cardiovascular disease such as new york heart association (nyha) ≥ ii, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pavk) ≥ grade 2 sickle cell anemia obesity (body mass index ≥ 30kg/m2) hospitalization at study inclusion administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period history of blood donation within 30 days of enrolment or planned donations within the study period known hypersensitivity to any of the components included in the covac-1 vaccine

1

University Hospital Tuebingen

18

100

Germany

Healthy volunteers

N/A

36

Safety -Vital Signs 2;Safety- Eastern Cooperative Oncology Group (ECOG) Status;Safety-Hematology 2;Safety-Hematology 1;Safety-Hematology 4;Safety-Blood Chemistry and Coagulation 1;Safety-Blood Chemistry and Coagulation 2;Safety -Vital Signs 3;Safety-Hematology 3

None

Phase 1

[{"arm_notes": "500 \u00b5l;1;SC;Age 18-55/Age 56-74/Age \u2265 75", "treatment_id": 639, "treatment_name": "Imp covac-1", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]