BCG VaccinationEarly Phase 1NCT06628544

Trained Immunity in Fungal Infection and Its Mechanism

A Early Phase 1 study testing BCG vaccination, Metformin is administered on the day 0 and Metformin is administered on the day 9 in people with BCG Vaccination, run by Zhongnan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: BCG Vaccination
What is being tested?: BCG vaccination, Metformin is administered on the day 0 and Metformin is administered on the day 9
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 1 siteChina
Study dates: 1 Sep 2020to 1 Dec 2023
Phase: Early Phase 1
Are there results?: None posted in the registry

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 20 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy BCG-naive participants.
The ages range from 20 to 45.
Participants without any infections or immune deficiencies.

Who cannot join

Participants when infections or other illnesses occurred during the clinical trial.
Participants who have a fever of unknown causes during the clinical trial.
Participants who have gotten other vaccines during the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Wuhan University
Wuhan, Hubei, China, 430072

Other trials in China

About this study

Official title: The Role of Trained Immunity in Fungal Infection and the Mechanism Behind it

Investigator vaccinated 76 healthy BCG-naive participant with BCG, while 3 participants received. Half of BCG-vaccinated participants (n = 38) received an incremental dose of metformin for 6 days (up to 1,000 mg twice daily on day 6). On the day 0 (total 20; n = 10 for BCG vaccination, n = 10 for BCG vaccination plus taking metformin), day 14 (total 30; n=15 for BCG vaccination, n = 15 for BCG vaccination plus taking metformin), day 90 (total 26; n = 13 for BCG vaccination, n=13 for BCG vaccination plus taking metformin) of BCG vaccination, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis.

Conditions: BCG Vaccination
Being tested: BCG vaccination, Metformin is administered on the day 0, Placebo, Metformin is administered on the day 9, Metformin is administered on the day 85
Keywords: immunity, metformin, BCG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BCG vaccinationBiological
BCG vaccination
Metformin is administered on the day 0Drug
Metformin is administered on the day 0
PlaceboOther
Placebo
Metformin is administered on the day 9Drug
Metformin is administered on the day 9
Metformin is administered on the day 85Drug
Metformin is administered on the day 85

Study groups in NCT06628544
Study group	Role	What they receive
BCG vaccination with taking metformin on the day 85	Experimental	Not described Receives: Biological: BCG vaccination; Drug: Metformin is administered on the day 85
BCG vaccination without metformin	Experimental	Not described Receives: Biological: BCG vaccination
Placebo	Placebo comparator	Not described Receives: Other: Placebo
BCG vaccination with taking metformin on the day 0	Experimental	Not described Receives: Biological: BCG vaccination; Drug: Metformin is administered on the day 0
BCG vaccination with taking metformin on the day 9	Experimental	Not described Receives: Biological: BCG vaccination; Drug: Metformin is administered on the day 9

What is being measured

The primary outcome is the main question the study is designed to answer.

The level of IL-6
After 5 days of continuous medication, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis. And the level of cytokines were determined by Elisa.
Measured: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis
The level of TGF-alpha
After 5 days of continuous medication, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis. And the level of cytokines were determined by Elisa.
Measured: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20201 Dec 2023

First posted8 Oct 2024
Study start1 Sep 2020
Primary completion31 Aug 2023
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BCG VaccinationStudies of the same condition, open and under way.
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: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Vaccines (BCG) and Drugs (Metformin)
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06628544
Sponsor's protocol ID: 2020005
Status last verified: Oct 2024
First submitted: 27 Sep 2024
Last updated: 8 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All BCG Vaccination trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Trained Immunity in Fungal Infection and the Mechanism Behind it
ClinicalTrials.gov ID: NCT06628544
Acronym / sponsor ID: 2020005
Conditions: BCG Vaccination
Keywords: immunity, metformin, BCG
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Zhongnan HospitalUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: 31 Aug 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 8 Oct 2024 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
Model description: Vaccines (BCG) and Drugs (Metformin)

Arm	Type	Receives
BCG vaccination with taking metformin on the day 85	Experimental	Biological: BCG vaccination, Drug: Metformin is administered on the day 85
BCG vaccination without metformin	Experimental	Biological: BCG vaccination
Placebo	Placebo comparator	Other: Placebo
BCG vaccination with taking metformin on the day 0	Experimental	Biological: BCG vaccination, Drug: Metformin is administered on the day 0
BCG vaccination with taking metformin on the day 9	Experimental	Biological: BCG vaccination, Drug: Metformin is administered on the day 9

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy BCG-naive participants.
The ages range from 20 to 45.
Participants without any infections or immune deficiencies.

Key exclusion criteria (3 listed)

Participants when infections or other illnesses occurred during the clinical trial.
Participants who have a fever of unknown causes during the clinical trial.
Participants who have gotten other vaccines during the clinical trial.

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
BCG vaccinationBCG vaccination	Biological	BCG vaccination with taking metformin on the day 0, BCG vaccination with taking metformin on the day 85, BCG vaccination with taking metformin on the day 9, BCG vaccination without metformin
Metformin is administered on the day 0Metformin is administered on the day 0	Drug	BCG vaccination with taking metformin on the day 0
PlaceboPlacebo	Other	Placebo
Metformin is administered on the day 9Metformin is administered on the day 9	Drug	BCG vaccination with taking metformin on the day 9
Metformin is administered on the day 85Metformin is administered on the day 85	Drug	BCG vaccination with taking metformin on the day 85

Primary outcome

The level of IL-6
Time frame: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis
After 5 days of continuous medication, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis. And the level of cytokines were determined by Elisa.
The level of TGF-alpha
Time frame: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis
After 5 days of continuous medication, PBMCs were isolated, restimulated with C. albicans or Mycobacterium tuberculosis. And the level of cytokines were determined by Elisa.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Individual participant dataSharing planned: No

Related trials for BCG Vaccination

Recruiting
ID93/GLA-SE Vaccination + BCG Challenge
Tuberculosis
RecruitingPhase 4
Antibiotics and Vaccine Immune Responses Study
Vaccine Response Impaired
Active, not recruitingPhase 2
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Diabetes Mellitus, Type 1, Diabetes type1
Active, not recruitingPhase 2
Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
Diabetes Mellitus, Type 1 Diabetes
Active, not recruitingPhase 2
Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes
Diabetes Mellitus, Type One, Diabetes Mellitus, Type I

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?

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Oct 2024. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The level of IL-6 (time frame: Five days of continuous medication+24 hours restimulation of C.albicans or Mycobacterium tuberculosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06628544.

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 8 Oct 2024.