Infection, Respiratory TractPhase 3NCT04387409
Study to Assess VPM1002 in Reducing Healthcare Professionals' Absenteeism in COVID-19 Pandemic
A Phase 3 study testing VPM1002 in people with Infection, Respiratory Tract, run by Serum Life Science Europe GmbH at 3 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection, Respiratory Tract
- What is being tested?
- VPM1002
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 3 sitesGermany
- Study dates
- 25 May 2020to 28 Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
SocraTec R&D GmbH
Erfurt, Thuringia, 99084
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Ludwig-Maximilians-Universität München
München, Bavaria, 80336
About this study
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
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.
Read more
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.
Read the detailed description
Based on the evidence that BCG vaccine
- can potentiate immune responses to other vaccines through induction of trained innate immunity and heterologous adaptive immunity and
- can reduce the incidence of respiratory infections, exert antiviral effects in experimental models, and reduce viremia in an experimental human model of viral infection, it is hypothesized that BCG vaccination may induce (partial) protection against the susceptibility to and/or severity of SARS- CoV-2 infection.
VPM1002 is being developed with the aim to replace BCG by a vaccine that has a better safety profile and superior efficacy. Evidence from pre-clinical and clinical studies demonstrate that VPM1002 is safer and is more immunogenic than the existing BCG vaccine. It is therefore anticipated that VPM1002 will also perform better in reducing the severity of the symptoms of an infection with the SARS CoV-2 than the BCG vaccine. Further, manufacturing of VPM1002 using state-of-the-art production methods will help hasten the production of millions of doses in a very short time and thus would be beneficial in the current SARS-CoV-2 pandemic situation.
The current trial will assess the efficacy and safety of VPM1002 to reduce health care professionals ' absenteeism in the SARS-CoV-2 pandemic by modulating the immune system.
A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high expected exposure to SARSCoV-2 infected patients (e.g. those employed in emergency departments, intensive care unit, infectious disease ward, COVID-19 isolation wards, respiratory wards, etc.) will be enrolled, across hospitals in Germany. Informed consent will be obtained from the subjects willing to take part in the trial. This will be followed by assessment of the eligibility criteria. Subjects who fulfil the inclusion/exclusion criteria will be centrally randomized in a 1:1 ratio to receive a single dose of either VPM1002 or Placebo.
All subjects will be requested to sign into a web-based tool designed for this trial. All subjects will be followed-up entirely remotely. The web-based questionnaires will be designed to collect data regarding absenteeism, adverse events / serious adverse events, hospitalizations, intensive care unit admissions and other secondary endpoints. The investigators will review the outcome and safety data.
- Conditions
- Infection, Respiratory Tract
- Being tested
- VPM1002, Placebo
- Keywords
- infectious respiratory diseases, COVID-19
- Medical subject headings
- Respiratory Tract Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPM1002Biological
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).
PlaceboBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: VPM1002 |
| Placebo | Placebo comparator | Physiological saline 0.1ml Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)
Measured: From day 0 to day 240
Secondary outcomes (13)
Cumulative incidence of documented SARS-CoV-2 infection
Measured: From day 0 to day 240
Number of days absent from work due to documented SARS-CoV-2 infection
Measured: From day 0 to day 240
Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection
Measured: 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)
Measured: From day 0 to day 240
Number of days of self-reported fever (≥ 38 °C)
Measured: From day 0 to day 240
Number of days of self-reported acute respiratory symptoms
Measured: From day 0 to day 240
Cumulative incidence of self-reported acute respiratory symptoms
Measured: From day 0 to day 240
Cumulative incidence of death for any reason
Measured: From day 0 to day 240
Cumulative incidence of death due to documented SARS-CoV-2 infection
Measured: From day 0 to day 240
Cumulative incidence of ICU admission for any reason
Measured: From day 0 to day 240
Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection
Measured: From day 0 to day 240
Cumulative incidence of hospital admission for any reason
Measured: From day 0 to day 240
Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection
Measured: From day 0 to day 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start25 May 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Respiratory TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Life Science Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Leander Grode, Dr rer nat, Study director, Serum Life Science Europe GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387409
- Sponsor's protocol ID
- VPM1002-DE-3.06CoV
- Status last verified
- Mar 2022
- First submitted
- 11 May 2020
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is uncertainty whether the European Union General Data Protection Regulation allows dissemination of individual participant data to other researchers. Some reasons why the EU Regulation would not allow this are the lack of suitable safeguards when person data are transferred to any researcher asking for it and the impairment of the rights of the subjects for erasure of their data once they are disseminated.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04387409
- Acronym / sponsor ID
- VPM1002-DE-3.06CoV
- Conditions
- Infection, Respiratory Tract
- Keywords
- infectious respiratory diseases, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Serum Life Science Europe GmbHIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 25 May 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Based on the evidence that BCG vaccine
- can potentiate immune responses to other vaccines through induction of trained innate immunity and heterologous adaptive immunity and
- can reduce the incidence of respiratory infections, exert antiviral effects in experimental models, and reduce viremia in an experimental human model of viral infection, it is hypothesized that BCG vaccination may induce (partial) protection against the susceptibility to and/or severity of SARS- CoV-2 infection.
VPM1002 is being developed with the aim to replace BCG by a vaccine that has a better safety profile and superior efficacy. Evidence from pre-clinical and clinical studies demonstrate that VPM1002 is safer and is more immunogenic than the existing BCG vaccine. It is therefore anticipated that VPM1002 will also perform better in reducing the severity of the symptoms of an infection with the SARS CoV-2 than the BCG vaccine. Further, manufacturing of VPM1002 using state-of-the-art production methods will help hasten the production of millions of doses in a very short time and thus would be beneficial in the current SARS-CoV-2 pandemic situation.
The current trial will assess the efficacy and safety of VPM1002 to reduce health care professionals ' absenteeism in the SARS-CoV-2 pandemic by modulating the immune system.
A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high expected exposure to SARSCoV-2 infected patients (e.g. those employed in emergency departments, intensive care unit, infectious disease ward, COVID-19 isolation wards, respiratory wards, etc.) will be enrolled, across hospitals in Germany. Informed consent will be obtained from the subjects willing to take part in the trial. This will be followed by assessment of the eligibility criteria. Subjects who fulfil the inclusion/exclusion criteria will be centrally randomized in a 1:1 ratio to receive a single dose of either VPM1002 or Placebo.
All subjects will be requested to sign into a web-based tool designed for this trial. All subjects will be followed-up entirely remotely. The web-based questionnaires will be designed to collect data regarding absenteeism, adverse events / serious adverse events, hospitalizations, intensive care unit admissions and other secondary endpoints. The investigators will review the outcome and safety data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VPM1002 | Active comparator | Biological: VPM1002The 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. |
| Placebo | Placebo comparator | Biological: PlaceboPhysiological saline 0.1ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPM1002The 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 | VPM1002 |
| PlaceboThe 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 |
Primary outcome
Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)
Time frame: From day 0 to day 240
13 secondary outcomes
Cumulative incidence of documented SARS-CoV-2 infection
Time frame: From day 0 to day 240
Number of days absent from work due to documented SARS-CoV-2 infection
Time frame: From day 0 to day 240
Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection
Time frame: 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)
Time frame: From day 0 to day 240
Number of days of self-reported fever (≥ 38 °C)
Time frame: From day 0 to day 240
Number of days of self-reported acute respiratory symptoms
Time frame: From day 0 to day 240
Cumulative incidence of self-reported acute respiratory symptoms
Time frame: From day 0 to day 240
Cumulative incidence of death for any reason
Time frame: From day 0 to day 240
Cumulative incidence of death due to documented SARS-CoV-2 infection
Time frame: From day 0 to day 240
Cumulative incidence of ICU admission for any reason
Time frame: From day 0 to day 240
Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection
Time frame: From day 0 to day 240
Cumulative incidence of hospital admission for any reason
Time frame: From day 0 to day 240
Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection
Time frame: From day 0 to day 240
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No. There is uncertainty whether the European Union General Data Protection Regulation allows dissemination of individual participant data to other researchers. Some reasons why the EU Regulation would not allow this are the lack of suitable safeguards when person data are transferred to any researcher asking for it and the impairment of the rights of the subjects for erasure of their data once they are disseminated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leander Grode, Dr rer nat study director
Serum Life Science Europe GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VPM1002 in people with Infection, Respiratory Tract, run by Serum Life Science Europe GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection) (time frame: From day 0 to day 240). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.