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CompletedNCT03296423ACTIVATEUpdated Jan 11, 2021

Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly

A Phase 4 interventional study of Vaccination and Placebo in Infection, Hospitalization and Mortality, sponsored by Hellenic Institute for the Study of Sepsis. Completed at 1 site in Greece. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by Hellenic Institute for the Study of Sepsis · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study summary

One small recent trial in elderly volunteers showed that BCG vaccination can protect against infectious complications, while several studies have demonstrated an increased capacity of innate immune responses to react against pathogens. This process, also called trained immunity, generates the hypothesis that BCG vaccination can prevent or delay new infections in the elderly patients and is studied in the ACTIVATE trial

Read the detailed description

In an era of antimicrobial resistance, where the already existing antimicrobials are not sufficient, the development of new strategies for the prevention and treatment of infections is of great interest. This approach becomes more and more mandatory in our current era of the financial crisis where bacterial infections by multidrug-resistant emerge and impose heavily on the financial burden of the disease. These infections occur more frequently among elderly patients leading to prolonged hospitalization where unfavorable outcome is not infrequent1. Vaccination is the traditional approach of infection prevention. A classic example focusing on the need to prevent morbid re-infection is vaccination with pneumococcal vaccine the incidence of pneumococcal pneumonia and bacteremia is enormously increasing among the elderly2. The principle of vaccination is to develop memory B-lymphocytes so that early and adequate antibody titers are produced upon re-exposure to the same antigen. This is called the memory function of the adaptive immune system.

Well before adaptive immunity develops proper recognition of a bacterial pathogen is done through binding of well-preserved structures known as pathogen-associated molecular patterns (PAMPs) on pattern-recognition receptors (PRRs) of the innate immune system and mainly of blood monocytes and tissue macrophages. Through a series of experiments in cell systems and animals, it was found that exposure of macrophages to small amounts of PAMPs like the β-glucan of Candida albicans and constituents of Mycobacterium tuberculosis may prevent death upon re-exposure to lethal bacterial challenges like C.albicans and Staphylococcus aureus3-6. Initial exposure to small amounts of PAMPs leads to epigenetic changes that induce the capacity of macrophages and monocytes to produce high amounts of pro-inflammatory cytokines like tumour necrosis factor-alpha (TNFα) and interferon-gamma (IFNγ) that clear efficiently the pathogen3. This enhancement of the immune cells reaction after appropriate priming to stimuli totally different from the initial ones is called trained immunity and it could be a potential pathway of preventing serious infections without having severe adverse effects.

The concept has also been tested in healthy volunteers that were vaccinated with placebo or BCG (Baccillus Calmette Guérin) vaccine. These volunteers were injected 14 days latter a tri-valent influenza A vaccine. Volunteers previous vaccinated by BCG developed significantly greater titers against hemagglutinin A of the influenza A virus whereas their circulating monocytes were more potent for the production of IFNγ7. Finally, a small study has recently reported that BCG vaccination of the elderly may protect against infections8, but larger studies are necessary to confirm these findings. This generates hopes that vaccination by BCG may increase immune resistance and/or tolerance of elderly patients upon exposure to bacterial infections.

This generates hopes that vaccination by BCG may increase immune tolerance of elderly patients upon exposure to bacterial diseases.

The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of elderly patients with BCG vaccine may modulate their disease susceptibility for bacterial diseases. This will be validated using both clinical and immunological criteria.

02

Conditions studied

  • Infection
  • Hospitalization
  • Mortality

Keywords

  • BCG vaccination
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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female
  • Age more than or equal to 65 years based on the precise date of birth
  • Discharge from hospital after hospitalization for a medical cause. All medical causes make patients eligible for enrolment with the only exception of medical causes mentioned in the exclusion criteria

Exclusion criteria

Exclusion Criteria:

  • Failure to obtain written informed consent
  • Solid organ malignancy or lymphoma diagnosed the last five years
  • Treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
  • Severely immunocompromised patients. This exclusion category comprises: a) patients with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic patients with less than 500 neutrophils/mm3; c) patients with solid organ transplantation; d) patients with bone marrow transplantation; e) patients under chemotherapy; f) patients with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies
  • Positive Interferon-gamma Release Assay (IGRA)
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    One intradermal injection of 0.1ml of sodium chloride 0.9%

    Biological: Placebo

  • Active comparator
    Vaccination

    One intradermal injection of 0.1ml of BCG (BCG vaccine Bulgaria strain 1331; Intervax)

    Biological: Vaccination

Interventions

  • BiologicalVaccination

    Patients discharged from hospital will be vaccinated with one intradermal injection of 0.1ml of BCG vaccine

    Also known as: BCG, Intervax

  • BiologicalPlacebo

    Patients discharged from hospital will be vaccinated with one intradermal injection of 0.1ml of sodium chloride 0.9%

    Also known as: Saline

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What researchers measure

Primary outcomes

  1. Time to first infection

    The time interval to the first infection post hospital discharge between the two groups of treatment.

    Time frame: 12 months

Secondary outcomes

  1. Hospitalization

    The rate of hospitalizations will be compared between the two groups of treatment

    Time frame: Month 12

  2. Time to first infection or sepsis episode

    The time to first infection or sepsis episode will be compared between the two groups of treatment

    Time frame: Month 12

  3. Total number of infections

    The total number of infections will be compared between the two groups of treatment

    Time frame: Month 12

  4. Time to first hospitalization

    The time to first hospitalization will be compared between the two groups of treatment

    Time frame: Month 12

  5. Number of antibiotic administrations

    The number of antibiotic administrations will be compared between the two groups of treatment

    Time frame: Month 12

  6. Mortality

    Mortality will be compared between the two groups of treatment

    Time frame: Month 12

  7. Cytokine stimulation

    Cytokine stimulation from peripheral blood monuclear cells will be compared between the two groups of treatment

    Time frame: Month 3

  8. Epigenetic changes

    Epigenetic changes of circulating monocytes will be compared between the two groups of treatment

    Time frame: Month 3

  9. Cost of treatment

    The effect of BCG vaccination on cost of treatment for infections will be compared between the two groups of treatment

    Time frame: Month 12

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Study locations

1 site
  • 4th Department of Internal Medicine, ATTIKON University Hospital
    Athens, Attiki 12462, Greece
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References and documents

Publications

  • Leentjens J, Kox M, Stokman R, Gerretsen J, Diavatopoulos DA, van Crevel R, Rimmelzwaan GF, Pickkers P, Netea MG. BCG Vaccination Enhances the Immunogenicity of Subsequent Influenza Vaccination in Healthy Volunteers: A Randomized, Placebo-Controlled Pilot Study. J Infect Dis. 2015 Dec 15;212(12):1930-8. doi: 10.1093/infdis/jiv332. Epub 2015 Jun 12. PubMed 26071565 ↗
  • Blok BA, Arts RJ, van Crevel R, Benn CS, Netea MG. Trained innate immunity as underlying mechanism for the long-term, nonspecific effects of vaccines. J Leukoc Biol. 2015 Sep;98(3):347-56. doi: 10.1189/jlb.5RI0315-096R. Epub 2015 Jul 6. PubMed 26150551 ↗
  • Giamarellos-Bourboulis EJ, Tsilika M, Moorlag S, Antonakos N, Kotsaki A, Dominguez-Andres J, Kyriazopoulou E, Gkavogianni T, Adami ME, Damoraki G, Koufargyris P, Karageorgos A, Bolanou A, Koenen H, van Crevel R, Droggiti DI, Renieris G, Papadopoulos A, Netea MG. Activate: Randomized Clinical Trial of BCG Vaccination against Infection in the Elderly. Cell. 2020 Oct 15;183(2):315-323.e9. doi: 10.1016/j.cell.2020.08.051. Epub 2020 Sep 1. PubMed 32941801 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03296423
Lead sponsor
Hellenic Institute for the Study of Sepsis
Collaborators
Radboud University Medical Center
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Sep 21, 2017
Primary completion
Aug 31, 2020
Completion
Nov 30, 2020
Last update
Jan 11, 2021

Study contacts

Antonios Papadopoulos, MD, PhD
principal investigator · National and Kapodistrian University of Athens

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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