BCG Vaccination Reaction, COVID-19, Infections, Inflammation
Conditions
Brief 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
Interventions
BIOLOGICALBCG
BCG vaccination
BIOLOGICALPlacebo vaccine
Placebo vaccination
Sponsors
UMC Utrecht
Radboud University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Completed participation in the BCG-CORONA-ELDERLY or BCG-PRIME study * Given consent to be approached for further studies
Exclusion criteria
* Has received a BCG vaccination after the BCG-CORONA-ELDERLY or BCG-PRIME study Inclusion Criteria from BCG-PRIME: * Age ≥60 years * Meeting at least one of the following criteria: 1. Having a chronic somatic disease\* 2. Having undergone major surgery\*\* 3. Planned to be discharged from the hospital or discharged from the hospital less than 6 weeks ago; a hospital admission is defined as an overnight stay. Departments of interest are those that in the opinion of the principle investigator admit mostly vulnerable elderly and include but are not limited to: cardiology, pulmonology, internal medicine, neurology. 4. Attending the thrombosis care service \* Chronic somatic diseases do not include risk factors such as hypertension or obesity unless the participant receives medication targeted against the risk factor. * Major surgery is any invasive operative procedure in which a more extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of infectious and inflammatory disease | One year after the end of participation in the BCG-CORONA-ELDERLY or BCG-PRIME study; the questions in the questionnaire are about events 'in the last year' (so from the moment of sending the questionnaire) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of various non-communicable diseases | One year after the end of participation in the BCG-CORONA-ELDERLY or BCG-PRIME study; the questions in the questionnaire are about events 'in the last year' (so from the moment of sending the questionnaire) |
Other
| Measure | Time frame |
|---|---|
| Use of antibiotics | One year after the end of participation in the BCG-CORONA-ELDERLY or BCG-PRIME study; the questions in the questionnaire are about events 'in the last year' (so from the moment of sending the questionnaire) |
| Vaccination status | One year after the end of participation in the BCG-CORONA-ELDERLY or BCG-PRIME study; the questions in the questionnaire are about events 'in the last year' (so from the moment of sending the questionnaire) |
| Incidence of infectious and inflammatory diseases | One year since last questionnaire (so between 1-2 years after completion of original BCG trial) |
| Incidence of various non-communicable diseases | One year since last questionnaire (so between 1-2 years after completion of original BCG trial) |
Countries
Netherlands
Outcome results
None listed