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

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ClinicalTrials.gov Identifier: NCT04435379
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : December 1, 2020
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by (Responsible Party):
Vakzine Projekt Management GmbH

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 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.


Condition or disease Intervention/treatment Phase
Infection, Respiratory Tract Biological: VPM1002 Biological: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2038 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Masking Description: The reconstitution of trial intervention will be done by unblinded site personnel who will not be involved in the collection or evaluation of outcome data. Administration of the trial intervention will be done by blinded site personnel.
Primary Purpose: Prevention
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
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VPM1002

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
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 Comparator: Placebo
Physiological saline 0.1ml
Biological: Placebo
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).




Primary Outcome Measures :
  1. Number of days with severe respiratory disease at hospital and/or at home [ Time Frame: From day 0 to day 240 ]

Secondary Outcome Measures :
  1. Cumulative incidence of hospital admissions [ Time Frame: From day 0 to day 240 ]
  2. Cumulative incidence of documented SARS-CoV-2 infection [ Time Frame: From day 0 to day 240 ]
  3. Number of days with self-reported fever (≥ 38 ºC) [ Time Frame: From day 0 to day 240 ]
  4. Number of days with self-reported acute respiratory symptoms [ Time Frame: From day 0 to day 240 ]
  5. Cumulative incidence of self-reported acute respiratory symptoms [ Time Frame: From day 0 to day 240 ]
  6. Cumulative incidence of death for any reason [ Time Frame: From day 0 to day 240 ]
  7. Cumulative incidence of death due to documented SARS-CoV-2 infection [ Time Frame: From day 0 to day 240 ]
  8. Cumulative incidence of ICU admission for any reason [ Time Frame: From day 0 to day 240 ]
  9. Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection [ Time Frame: From day 0 to day 240 ]
  10. Cumulative incidence of hospital admission due to documented SARSCoV- 2 infection [ Time Frame: From day 0 to day 240 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female adult (≥ 60 years)
  2. Subject is contractually capable, able to understand information on study and has signed informed consent sheet
  3. Subject has access to an internet-enabled electronic device

Exclusion Criteria:

  1. Known active or latent Mycobacterium tuberculosis infection
  2. Fever (> 38 °C) or respiratory tract infection within the past 24 hours
  3. Current active viral or bacterial infection
  4. Expected vaccination during the study period; vaccinations against influenza and pneumococcal disease are allowed with ≥ 4 weeks between these vaccinations and the trial vaccination
  5. Participation in another interventional study within 30 days before screening and during this study
  6. Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior Bacille Calmette-Guérin (BCG) administration
  7. Severely immunocompromised subjects, including:

    1. subjects with known infection by the human immunodeficiency virus (HIV-1);
    2. subjects with solid organ transplantation;
    3. subjects with bone marrow transplantation;
    4. subjects under chemotherapy, immunotherapy, or 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, or likely use of oral or intravenous steroids in the next 4 weeks;
  8. 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
  9. Previous positive SARS-CoV-2 test result
  10. Person is an employee of the sponsor, a relative of the sponsor or investigator, or is employed in the same department as the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435379


Contacts
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Contact: Leander Grode, Dr. rer. nat. +49 (0)511 169908-14 grode@vakzine-manager.de

Locations
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Germany
Hautarztpraxis Dres. Leitz & Kollegen Recruiting
Stuttgart, Baden-Württemberg, Germany, 70178
Contact: Leander Grode, Dr. rer. nat    +49 (0)511 169908-14      
MECS Cottbus GmbH Recruiting
Cottbus, Brandenburg, Germany, 03050
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
Studienzentrum Dr. Keller Recruiting
Frankfurt, Hessen, Germany, 60389
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
Klinische Forschung Hannover Mitte GmbH Recruiting
Hannover, Niedersachsen, Germany, 30159
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
Medizentrum Essen Borbeck Recruiting
Essen, Nordrhein-Westfalen, Germany, 45355
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
BAG Dres. med. Quist PartG Recruiting
Mainz, Rheinland-Pfalz, Germany, 55128
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
SIBAmed GmbH & Co. KG Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Leander Grode, Dr. rer .nat.    +49 (0)511 169908-14      
SocraTec R&D GmbH Recruiting
Erfurt, Thüringen, Germany, 99084
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
emovis GmbH Recruiting
Berlin, Germany, 10629
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
Klinische Forschung Berlin GbR Recruiting
Berlin, Germany, 10787
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
Klinische Forschung Hamburg GmbH Recruiting
Hamburg, Germany, 20253
Contact: Leander Grode, Dr. rer. nat.    +49 (0)511 169908-14      
Sponsors and Collaborators
Vakzine Projekt Management GmbH
FGK Clinical Research GmbH
Investigators
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Study Director: Leander Grode, Dr. rer. nat. Vakzine Projekt Management GmbH
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Responsible Party: Vakzine Projekt Management GmbH
ClinicalTrials.gov Identifier: NCT04435379    
Other Study ID Numbers: VPM1002-DE-3.07CoV
2020-001675-33 ( EudraCT Number )
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vakzine Projekt Management GmbH:
infectious respiratory diseases
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases