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Long Term Effects of BCG Vaccination on Infectious and Immune Mediated Diseases (BCG-LT)

NCT05387655 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsorRadboud University Medical Center
StatusACTIVE_NOT_RECRUITING
Enrolment4292
Start dateFri May 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionSun Jun 20 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Netherlands