Status:
COMPLETED
Study to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 Pandemic
Lead Sponsor:
Serum Life Science Europe GmbH
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Infection, Respiratory Tract
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to investigate whether vaccination of elderly with VPM1002 could reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2 pandemic . VPM1002...
Detailed Description
Based on the evidence that BCG \[Bacille Calmette-Guérin\] vaccine 1. can potentiate immune responses to other vaccines through induction of trained innate immunity and heterologous adaptive immunity...
Eligibility Criteria
Inclusion
- Male or female adult (≥ 60 years)
- 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
Exclusion
- Known active or latent Mycobacterium tuberculosis infection
- Fever (\> 38 °C) or respiratory tract infection within the past 24 hours
- Current active viral or bacterial infection
- Expected vaccination during the study period; vaccinations against influenza and pneumococcal disease are allowed with ≥ 4 weeks between these vaccinations and the trial vaccination
- Participation in another interventional study within 30 days before screening and during this study
- Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior Bacille Calmette-Guérin (BCG) administration
- Severely immunocompromised subjects, including:
- subjects with known infection by the human immunodeficiency virus (HIV-1);
- subjects with solid organ transplantation;
- subjects with bone marrow transplantation;
- subjects under chemotherapy, immunotherapy, or 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, or likely use of oral or intravenous steroids in the next 4 weeks;
- 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
- Previous positive SARS-CoV-2 test result
- Person is an employee of the sponsor, a relative of the sponsor or investigator, or is employed in the same department as the investigator
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2021
Estimated Enrollment :
2038 Patients enrolled
Trial Details
Trial ID
NCT04435379
Start Date
June 18 2020
End Date
October 12 2021
Last Update
October 26 2021
Active Locations (12)
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1
Hautarztpraxis Dres. Leitz & Kollegen
Stuttgart, Baden-Wurttemberg, Germany, 70178
2
MECS Cottbus GmbH
Cottbus, Brandenburg, Germany, 03050
3
Studienzentrum Dr. Keller
Frankfurt am Main, Hesse, Germany, 60389
4
Klinische Forschung Hannover Mitte GmbH
Hanover, Lower Saxony, Germany, 30159