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

NCT04435379 | Completed Phase 3 DMC

• 2 other identifiers: VPM1002-DE-3.07CoV2020-001675-33
• Study Type: interventional
• Target: 2,038
• Locations: 1 country
• Sites: 12

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.

Conditions

Infection, Respiratory Tract

Keywords

infectious respiratory diseases

Outcome Measures

Primary Outcomes (1)

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

  From day 0 to day 240

Secondary Outcomes (10)

• Cumulative incidence of hospital admissions

  From day 0 to day 240

• Cumulative incidence of documented SARS-CoV-2 infection

  From day 0 to day 240

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

  From day 0 to day 240

• Number of days with self-reported acute respiratory symptoms

  From day 0 to day 240

• Cumulative incidence of self-reported acute respiratory symptoms

  From day 0 to day 240

Study Arms (2)

VPM1002

EXPERIMENTAL

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (12)

Hautarztpraxis Dres. Leitz & Kollegen

Stuttgart, Baden-Wurttemberg, 70178, Germany

Location

MECS Cottbus GmbH

Cottbus, Brandenburg, 03050, Germany

Location

Studienzentrum Dr. Keller

Frankfurt am Main, Hesse, 60389, Germany

Location

Klinische Forschung Hannover Mitte GmbH

Hanover, Lower Saxony, 30159, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Medizentrum Essen Borbeck

Essen, North Rhine-Westphalia, 45355, Germany

Location

BAG Dres. med. Quist PartG

Mainz, Rhineland-Palatinate, 55128, Germany

Location

SIBAmed GmbH & Co. KG

Leipzig, Saxony, 04103, Germany

Location

SocraTec R&D GmbH

Erfurt, Thuringia, 99084, Germany

Location

emovis GmbH

Berlin, 10629, Germany

Location

Klinische Forschung Berlin GbR

Berlin, 10787, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Related Publications (1)

• 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.

  PMID: 36358012 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

VPM1002 recombinant BCG vaccine

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract 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 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.
• 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: June 16, 2020
• First Posted: June 17, 2020
• Study Start: June 18, 2020
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)