Status:
UNKNOWN
Study to Assess VPM1002 in Reducing Healthcare Professionals' Absenteeism in COVID-19 Pandemic
Lead Sponsor:
Serum Life Science Europe GmbH
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Infection, Respiratory Tract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to investigate whether vaccination of healthcare professionals with VPM1002 could reduce the number of days absent from work due to respiratory disease (with or without docume...
Detailed Description
Based on the evidence that BCG vaccine 1. can potentiate immune responses to other vaccines through induction of trained innate immunity and heterologous adaptive immunity and 2. can reduce the incid...
Eligibility Criteria
Inclusion
- Adult (≥18 years)
- Male or female
- Hospital personnel with expected high SARS-CoV-2 exposure
- 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 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.
Exclusion
- 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 study within 30 days before screening and during this study
- 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:
- subjects with known infection with the human immunodeficiency virus (HIV);
- subjects with solid organ transplantation;
- subjects with bone marrow transplantation;
- subjects under chemotherapy, immunotherapy and radiotherapy;
- subjects with primary immunodeficiency;
- treatment with any anti-cytokine therapies;
- 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)
- Employed to the hospital \< 22 hours per week
- Previous positive SARS-CoV-2 test result
Key Trial Info
Start Date :
May 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04387409
Start Date
May 25 2020
End Date
May 1 2021
Last Update
September 30 2020
Active Locations (3)
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1
Ludwig-Maximilians-Universität München
München, Bavaria, Germany, 80336
2
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
3
SocraTec R&D GmbH
Erfurt, Thuringia, Germany, 99084