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: • Adult (=18 years) • Male or female • Healthcare professionals taking care of potentially SARS-CoV-2 infected patients • Subject is contractually capable, able to understand information on study and has signed informed consent sheet • Subject has access to an internet-enabled electronic device • Women of childbearing potential (WOCBP) who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination. 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 1080 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: • Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior BCG administration • Known active or latent Mycobacterium tuberculosis infection or with another mycobacterial species. A history with or suspicion of M. tuberculosis infection. • Fever (>38 °C) within the past 24 hours • Pregnant or breast-feeding • Suspicion of active viral or bacterial infection • Participation of subject in another interventional study within 30 days before screening • Person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site • Severely immunocompromised subjects, such as: a) subjects with known infection with the human immunodeficiency virus (HIV); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy, immunotherapy and 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 • Active solid or non-solid malignancy or lymphoma in the past 5 years • Direct involvement in the design or the execution of the present clinical trial • Expected absence from work of =4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) • Employment of less than 50% a full-time equivalent • Previous positive SARS-CoV-2 test result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the reduction of absenteeism among HCPs with direct patient contacts during the epidemic phase of COVID-19.;Secondary Objective: To assess the incidence of SARS-CoV-2 infection or symptoms of infection, reduction of hospital admission, ICU admission or death in HCPs with direct patient contacts during the epidemic phase of COVID-19.;Primary end point(s): Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection);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 documented SARS-CoV-2 infection • Number of days absent from work due to documented SARS-CoV-2 infection Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection • Number of days absent from work due to symptoms of respiratory disease, documented SARS-CoV-2 infection, or fever (= 38 °C) • Number of days of self-reported fever (=38°C) • Number of days of 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 for any reason • 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