BCG Vaccination ReactionBCG-LTNCT05387655
Long Term Effects of BCG Vaccination on Infectious and Immune Mediated Diseases
An observational study of BCG Vaccination Reaction and Infections, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- BCG Vaccination Reaction, Infections, Inflammation
- What is being tested?
- BCG
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,292 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 May 2022to 20 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Completed participation in the BCG-CORONA-ELDERLY or BCG-PRIME study
- Given consent to be approached for further studies
- Age ≥60 years
- Meeting at least one of the following criteria:
- Having a chronic somatic disease*
- Having undergone major surgery**
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- 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
- Adult (≥ 60 years)
- Written informed consent
Who cannot join
- Has received a BCG vaccination after the BCG-CORONA-ELDERLY or BCG-PRIME study
- Fever (>38 ºC) within the past 24 hours
- Suspicion of current active viral or bacterial infection; the requirement to finish an antibiotic course upon discharge is not an exclusion criterion when the infection is controlled in the opinion of the attending physician
- Vaccination with live vaccine in the past four weeks or planned vaccination with live vaccine during the next four weeks
- Severely immunocompromised participants. This exclusion category comprises:
- known infection by the human immunodeficiency virus (HIV-1);
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- neutropenic with less than 500 neutrophils/mm3;
- solid organ transplantation;
- bone marrow transplantation;
- hematological malignancy;
- chemo-, radio- or immunotherapy for solid organ malignancy in the past 6 months;
- primary immunodeficiency;
- severe lymphopenia with less than 400 lymphocytes/mm3;
- treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of >10 mg/day or a cumulative dose of >700 mg prednisone or equivalent for other corticosteroids in the three months prior to enrolment, or probable use of oral or intravenous steroids in the following four weeks;
- receiving chronic renal replacement therapy.
- Known history of a positive Mantoux or active TB; prior BCG vaccination or a positive Mantoux test after BCG vaccination without confirmation of TB are NOT an exclusion criterion.
- Born in a country with high incidence of TB (see supplement B)
- Active participation in another research study that involves BCG administration
- History of documented COVID-19 (self-reported by the participant: either confirmed by a microbiological test or with clinical diagnosis during hospitalization)
- Not able to perform the study procedures as judged by the attending physician
- Legally incapacitated or unwilling to provide informed consent
- Fever (>38 ºC) within the past 24 hours
- Suspicion of current active viral or bacterial infection
- Expected vaccination during the first three months of the study period
- Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks
- Active solid or non-solid malignancy or lymphoma within the prior two years
- Active participation in another research study that involves BCG administration
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525GA
About this study
Official title: Long Term Assessment of Infectious Diseases and Immune Mediated Disorders After BCG (re)Vaccination
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
Read more
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
- Being tested
- BCG, Placebo vaccine
- Medical subject headings
- Infections, Inflammation, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCGBiological
BCG vaccination
Placebo vaccineBiological
Placebo vaccination
| Study group | Role | What they receive |
|---|---|---|
| BCG vaccination | People who received a BCG vaccination in the prior BCG-CORONA-ELDERLY or BCG-PRIME study Receives: Biological: BCG | |
| Placebo vaccination | People who received a placebo vaccination in the prior BCG-CORONA-ELDERLY or BCG-PRIME study Receives: Biological: Placebo vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infectious and inflammatory disease
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start20 May 2022
- Primary completion15 May 2023
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCG Vaccination ReactionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387655
- Sponsor's protocol ID
- 2022-13462
- Acronym
- BCG-LT
- Status last verified
- Apr 2025
- First submitted
- 12 May 2022
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Assessment of Infectious Diseases and Immune Mediated Disorders After BCG (re)Vaccination
- ClinicalTrials.gov ID
- NCT05387655
- Acronym / sponsor ID
- BCG-LT / 2022-13462
- Conditions
- BCG Vaccination Reaction, Infections, Inflammation, COVID-19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,292 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- 20 May 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG vaccination | – | Biological: BCGPeople who received a BCG vaccination in the prior BCG-CORONA-ELDERLY or BCG-PRIME study |
| Placebo vaccination | – | Biological: Placebo vaccinePeople who received a placebo vaccination in the prior BCG-CORONA-ELDERLY or BCG-PRIME study |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Completed participation in the BCG-CORONA-ELDERLY or BCG-PRIME study
- Given consent to be approached for further studies
- Age ≥60 years
- Meeting at least one of the following criteria:
- Adult (≥ 60 years)
Key exclusion criteria (27 listed)
- Has received a BCG vaccination after the BCG-CORONA-ELDERLY or BCG-PRIME study
- Fever (>38 ºC) within the past 24 hours
- Suspicion of current active viral or bacterial infection; the requirement to finish an antibiotic course upon discharge is not an exclusion criterion when the infection is controlled in the opinion of the attending physician
- Vaccination with live vaccine in the past four weeks or planned vaccination with live vaccine during the next four weeks
- Severely immunocompromised participants. This exclusion category comprises:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCGBCG vaccination | Biological | BCG vaccination |
| Placebo vaccinePlacebo vaccination | Biological | Placebo vaccination |
Primary outcome
Incidence of infectious and inflammatory disease
Time frame: 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)
1 secondary outcome
Incidence of various non-communicable diseases
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BCG Vaccination Reaction and Infections, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infectious and inflammatory disease (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.