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

NCT04387409 | Completed Phase 3 DMC

• 1 other identifier: VPM1002-DE-3.06CoV
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Infection, Respiratory Tract

Keywords

infectious respiratory diseases; COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)

  From day 0 to day 240

Secondary Outcomes (13)

• Cumulative incidence of documented SARS-CoV-2 infection

  From day 0 to day 240

• Number of days absent from work due to documented SARS-CoV-2 infection

  From day 0 to day 240

• Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection

  From day 0 to day 240

• Number of days absent from work due to symptoms of respiratory disease, documented SARS-CoV-2 infection, or fever (≥ 38 °C)

  From day 0 to day 240

• Number of days of self-reported fever (≥ 38 °C)

  From day 0 to day 240

Study Arms (2)

VPM1002

ACTIVE COMPARATOR

The active ingredient of the recombinant BCG vaccine, VPM1002, is Mycobacterium bovis rBCGΔureC::hly, freeze-dried and standardized to the number of viable mycobacteria (colony forming units; CFU) per application. Dose: 2-8 x 10e5 CFU VPM1002 administered in 0.1 ml reconstituted suspension.

Biological: VPM1002

Placebo

PLACEBO COMPARATOR

Physiological saline 0.1ml

Biological: Placebo

Interventions

VPM1002 BIOLOGICAL

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).

VPM1002

Placebo BIOLOGICAL

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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Serum Life Science Europe GmbH: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (3)

Ludwig-Maximilians-Universität München

München, Bavaria, 80336, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

SocraTec R&D GmbH

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Conditions

Respiratory Tract Infections; COVID-19

Interventions

VPM1002 recombinant BCG vaccine

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Leander Grode, Dr rer nat

  Serum Life Science Europe GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The reconstitution and administration of trial intervention will be done by unblinded site personnel who will not be involved in the collection or evaluation of outcome data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects who fulfil the inclusion/exclusion criteria will be centrally randomized in a 1:1 ratio to receive a single dose (0.1 ml) of either VPM1002 or Placebo.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 13, 2020
• Study Start: May 25, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: April 23, 2026

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)