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Long Term Effects of BCG Vaccination on Infectious and Immune Mediated Diseases

NCT05387655 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4292

Last updated 2025-04-20

No results posted yet for this study

Summary

Rationale: The effects of BCG vaccination have been only sporadically studied in the elderly, and the long-term effects of the vaccination have not been studied until now. There is evidence that BCG vaccination beneficially influences susceptibility and severity of infectious and inflammatory diseases; however, the specifics, extent and duration of these effects are not known yet. With this observational study we would like to determine the extent of these effects in the elderly.

Objective: To identify any long term effects of BCG vaccination on the incidence of infectious and inflammatory diseases may have in the elderly

Study design: Cohort study with a duration of 5 years

Study population: Older adults who participated in two large randomized BCG vaccination trials in 2020/2021 (BCG-CORONA-OUDEREN, BCG-PRIME), who have consented to be contacted for further studies

Main study parameters/endpoints:

The incidence of infectious and inflammatory diseases in the placebo- vs. BCG-vaccinated individuals

Conditions

Interventions

BIOLOGICAL

BCG

BCG vaccination

BIOLOGICAL

Placebo vaccine

Placebo vaccination

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2023-05-15
Completion
2027-06-20

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT05387655 on ClinicalTrials.gov