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Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly

NCT03296423 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-01-11

No results posted yet for this 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

Conditions

Interventions

BIOLOGICAL

Vaccination

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2020-08-31
Completion
2020-11-30

Countries

  • Greece

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296423 on ClinicalTrials.gov