infectious respiratory diseases (e.g. COVID-19) MedDRA version: 20.0 Level: HLGT Classification code 10024970 Term: Respiratory tract infections System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Sponsors
Vakzine Projekt Management GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1538
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the reduction of days with severe respiratory infectious diseases at hospital and/or at home in elderly subjects during the pandemic of SARS-CoV-2;Secondary Objective: To assess the reduction of disease severity, the duration of hospital admission, intensive care unit (ICU) admission, or death in elderly subjects during the pandemic of SARS-CoV-2;Primary end point(s): Number of days with severe respiratory disease at hospital and/or at home;Timepoint(s) of evaluation of this end point: From day 0 to day 240 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Cumulative incidence of hospital admissions • Cumulative incidence of documented SARS-CoV-2 infection • Number of days with self-reported fever (= 38 ºC) • Number of days with self-reported acute respiratory symptoms • Cumulative incidence of self-reported acute respiratory symptoms • Cumulative incidence of death for any reason • Cumulative incidence of death due to documented SARS-CoV-2 infection • Cumulative incidence of ICU admission for any reason • Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection • Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection;Timepoint(s) of evaluation of this end point: From day 0 to day 240 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information
Vakzine Projekt Management GmbH
Outcome results
None listed