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NCT04387409

PHASE3

Study to Assess VPM1002 in Reducing Healthcare Professionals' Absenteeism in COVID-19 Pandemic

Sponsor: Serum Life Science Europe GmbH

View on ClinicalTrials.gov

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 documented SARS-CoV-2 infection). VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the new corona virus "SARS-CoV 2". A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high expected exposure to SARSCoV-2 infected patients will receive a single dose of either VPM1002 or Placebo. All subjects will be requested to enter data regarding absenteeism, adverse events / serious adverse events, hospitalizations, intensive care unit admissions into an online questionnaire.

Official title: A Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Healthcare Professionals' Absenteeism in the SARS-CoV-2 Pandemic by Modulating the Immune System

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-05-25

Completion Date

2021-04-28

Last Updated

2026-04-23

Healthy Volunteers

Yes

Conditions

Infection, Respiratory Tract

Interventions

BIOLOGICAL

VPM1002

The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).

BIOLOGICAL

Placebo

Inclusion Criteria: * 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 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 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: 1. subjects with known infection with the human immunodeficiency virus (HIV); 2. subjects with solid organ transplantation; 3. subjects with bone marrow transplantation; 4. subjects under chemotherapy, immunotherapy and radiotherapy; 5. subjects with primary immunodeficiency; 6. treatment with any anti-cytokine therapies; 7. 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

Locations (3)

Ludwig-Maximilians-Universität München

München, Bavaria, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

SocraTec R&D GmbH

Erfurt, Thuringia, Germany