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

NCT05387655 | Active Not Recruiting

• 1 other identifier: 2022-13462
• Study Type: observational
• Target: 4,292
• Locations: 1 country
• Sites: 1

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

Conditions

BCG Vaccination Reaction; Infections; Inflammation; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (18)

• 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)

Study Arms (2)

BCG vaccination

People who received a BCG vaccination in the prior BCG-CORONA-ELDERLY or BCG-PRIME study

Biological: BCG

Placebo vaccination

People who received a placebo vaccination in the prior BCG-CORONA-ELDERLY or BCG-PRIME study

Biological: Placebo vaccine

Interventions

BCG BIOLOGICAL

BCG vaccination

BCG vaccination

Placebo vaccine BIOLOGICAL

Placebo vaccination

Placebo vaccination

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of participants who previsouly participated in the BCG-CORONA-ELDERLY or BCG-PRIME study and gave consent for further participation. All former participants will receive an invitation to join this LongTerm study.

You may qualify if:

• Completed participation in the BCG-CORONA-ELDERLY or BCG-PRIME study
• Given consent to be approached for further studies

You may not qualify if:

• Has received a BCG vaccination after the BCG-CORONA-ELDERLY or BCG-PRIME study
• Age ≥60 years
• Meeting at least one of the following criteria:
• Having a chronic somatic disease\*
• Having undergone major surgery\*\*
• 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.
• 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
• Fever (\>38 ºC) within the past 24 hours
• Vaccination with live vaccine in the past four weeks or planned vaccination with live vaccine during the next four weeks
• known infection by the human immunodeficiency virus (HIV-1);
• neutropenic with less than 500 neutrophils/mm3;
• solid organ transplantation;
• bone marrow transplantation;
• hematological malignancy;

Sponsors & Collaborators

• Radboud University Medical Center: lead
• UMC Utrecht: collaborator

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Infections; Inflammation; COVID-19

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 24, 2022
• Study Start: May 20, 2022
• Primary Completion: May 15, 2023
• Study Completion (Estimated): June 20, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)