COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001675-33/DE

Vakzine Projekt Management GmbH - Clinical Trial Information

info@vakzine-manager.de

2020-04-17

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Male or female adult (≥ 60 years) 2. Subject is contractually capable, able to understand information on study and has signed informed consent sheet 3. Subject has access to an internet-enabled electronic device

1. Known active or latent Mycobacterium tuberculosis infection 2. Fever (> 38 °C) or respiratory tract infection within the past 24 hours 3. Current active viral or bacterial infection 4. Expected vaccination during the study period, vaccinations against influenza and pneumococcal disease are allowed with ≥ 4 weeks between these vaccinations and the trial vaccination 5. Participation in another interventional study within 30 days before screening and during this study 6. Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior Bacille Calmette-Guérin (BCG) administration 7. Severely immunocompromised subjects, including: (a) subjects with known infection by the human immunodeficiency virus (HIV-1), (b) subjects with solid organ transplantation, (c) subjects with bone marrow transplantation, (d) subjects under chemotherapy, immunotherapy, or radiotherapy, (e) subjects with primary immunodeficiency, (f) treatment with any anti-cytokine therapies, (g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months, or likely use of oral or intravenous steroids in the next 4 weeks, 8. History of malignancies, unless the subject has been free of the disease for ≥ 2 years, exception: subjects with adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer and adequately treated carcinoma in situ of the cervix may participate in the trial 9. Previous positive SARS-CoV-2 test result 10. Person is an employee of the sponsor, a relative of the sponsor or investigator, or is employed in the same department as the investigator

2

Vakzine Projekt Management GmbH

60

100

Germany

Mild disease at enrollment

1: Mild disease at enrollment

2038

Number of days with severe respiratory disease at hospital and/or at home

Declared number of arm (3.0) differs from found arms (2.0)

Phase 3

[{"arm_notes": "Not reported", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "Medical condition including lung infectious disease including COVID-19;Not reported", "treatment_id": 1378, "treatment_name": "Vpm1002", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]