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Infection, Respiratory TractPhase 3NCT04435379

Study to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 Pandemic

A Phase 3 study testing VPM1002 in people with Infection, Respiratory Tract, run by Serum Life Science Europe GmbH at 12 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Infection, Respiratory Tract
What is being tested?
VPM1002
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,038 participants
Where
12 sitesGermany
Study dates
18 Jun 2020to 12 Oct 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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • emovis GmbH

    Berlin, 10629

  • Klinische Forschung Berlin GbR

    Berlin, 10787

  • MECS Cottbus GmbH

    Cottbus, Brandenburg, 03050

  • SocraTec R&D GmbH

    Erfurt, Thuringia, 99084

  • Medizentrum Essen Borbeck

    Essen, North Rhine-Westphalia, 45355

  • Studienzentrum Dr. Keller

    Frankfurt am Main, Hesse, 60389

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • Klinische Forschung Hannover Mitte GmbH

    Hanover, Lower Saxony, 30159

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • SIBAmed GmbH & Co. KG

    Leipzig, Saxony, 04103

  • BAG Dres. med. Quist PartG

    Mainz, Rhineland-Palatinate, 55128

  • Hautarztpraxis Dres. Leitz & Kollegen

    Stuttgart, Baden-Wurttemberg, 70178

Other trials in Germany

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicentre, Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in the SARS-CoV-2 Pandemic by Modulating the Immune System

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 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.

Read the 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, and
  2. 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 infections.

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 (for more information, please revert to the IB). 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 the hospital admissions and clinical consequences of SARS-CoV-2 infections in the elderly population in the SARS-CoV-2 pandemic by modulating the immune system.

A total of 2038 adults aged 60 or above will be enrolled across involved clinical trial sites 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 (0.1 ml) of either VPM1002 or Placebo.

All subjects will be requested to sign into a web-based tool designed for this trial. Every subject is encouraged to name a designated caregiver who may provide follow-up data in case of hospitalisation or severe illness of the study subject. All subjects will be followed-up entirely remotely. The questionnaires will be designed to collect data regarding hospitalisation, adverse events (AE)/serious adverse events (SAE), ICU admissions and other secondary endpoints. The investigators will review the outcome and safety data.

The duration of follow-up will be 240 days. Subjects with confirmed SARS-CoV-2 infection (with or without symptoms) will be followed for at least 6 weeks (from the date of test result), independent of the total trial duration.

Being tested
VPM1002, Placebo
Keywords
infectious respiratory diseases
Medical subject headings
Respiratory Tract Infections

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 groups in NCT04435379
Study groupRoleWhat they receive
VPM1002ExperimentalThe 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
PlaceboPlacebo comparatorPhysiological saline 0.1ml
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of days with severe respiratory disease at hospital and/or at home

    Measured: From day 0 to day 240

Secondary outcomes (10)

  1. Cumulative incidence of hospital admissions

    Measured: From day 0 to day 240

  2. Cumulative incidence of documented SARS-CoV-2 infection

    Measured: From day 0 to day 240

  3. Number of days with self-reported fever (≥ 38 ºC)

    Measured: From day 0 to day 240

  4. Number of days with self-reported acute respiratory symptoms

    Measured: From day 0 to day 240

  5. Cumulative incidence of self-reported acute respiratory symptoms

    Measured: From day 0 to day 240

  6. Cumulative incidence of death for any reason

    Measured: From day 0 to day 240

  7. Cumulative incidence of death due to documented SARS-CoV-2 infection

    Measured: From day 0 to day 240

  8. Cumulative incidence of ICU admission for any reason

    Measured: From day 0 to day 240

  9. Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection

    Measured: From day 0 to day 240

  10. Cumulative incidence of hospital admission due to documented SARSCoV- 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.

  1. First posted17 Jun 2020
  2. Study start18 Jun 2020
  3. Primary completion12 Oct 2021
  4. Study completion12 Oct 2021

Resources

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
2,038 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04435379
Sponsor's protocol ID
VPM1002-DE-3.07CoV
Other IDs
2020-001675-33
Status last verified
Oct 2021
First submitted
16 Jun 2020
Last updated
26 Oct 2021
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 personal 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.

Publications

  • Blossey AM, Bruckner S, May M, Parzmair GP, Sharma H, Shaligram U, Grode L, Kaufmann SHE, Netea MG, Schindler C. VPM1002 as Prophylaxis Against Severe Respiratory Tract Infections Including Coronavirus Disease 2019 in the Elderly: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study. Clin Infect Dis. 2023 Apr 3;76(7):1304-1310. doi: 10.1093/cid/ciac881.

    PubMed 36358012

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 12 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 3 inclusion and 17 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 with severe respiratory disease at hospital and/or at home (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?

On the ClinicalTrials.gov record for NCT04435379, which also lists 1 linked publication.

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 26 Oct 2021.

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