NCT03296423

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2.9 years

First QC Date

September 20, 2017

Last Update Submit

January 8, 2021

Conditions

InfectionHospitalizationMortality

Keywords

BCG vaccination

Outcome Measures

Primary Outcomes (1)

  • Time to first infection

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

    12 months

Secondary Outcomes (9)

  • Hospitalization

    Month 12

  • Time to first infection or sepsis episode

    Month 12

  • Total number of infections

    Month 12

  • Time to first hospitalization

    Month 12

  • Number of antibiotic administrations

    Month 12

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One intradermal injection of 0.1ml of sodium chloride 0.9%

Biological: Placebo

Vaccination

ACTIVE COMPARATOR

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

Biological: Vaccination

Interventions

VaccinationBIOLOGICAL

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

Also known as: BCG, Intervax
Vaccination
PlaceboBIOLOGICAL

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

Also known as: Saline
Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male or female
  • Age more than or equal to 65 years based on the precise date of birth

You may not qualify if:

  • 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
  • Positive Interferon-gamma Release Assay (IGRA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, Attica, 12462, Greece

Location

Related Publications (3)

  • 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.

    PMID: 26071565BACKGROUND

  • 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.

    PMID: 26150551BACKGROUND

  • 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.

    PMID: 32941801DERIVED

MeSH Terms

Conditions

Infections

Interventions

VaccinationSodium Chloride

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public HealthChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Antonios Papadopoulos, MD, PhD

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients vaccinated with placebo or BCG
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 28, 2017

Study Start

September 21, 2017

Primary Completion

August 31, 2020

Study Completion

November 30, 2020

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)