NCT05387655

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

Long Term Assessment of Infectious Diseases and Immune Mediated Disorders After BCG (re)Vaccination

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,292 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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

• BCG Vaccination Reaction
• Infections
• Inflammation
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BCG	BCG vaccination
BIOLOGICAL	Placebo vaccine	Placebo vaccination

Timeline

• Start date: 2022-05-20
• Primary completion: 2023-05-15
• Completion: 2027-06-20
• First posted: 2022-05-24
• Last updated: 2025-04-20

Locations

1 site across 1 country: Netherlands