Trained ImmunityPhase 4NEXTNCT05766345
BCG-induced Epigenetic Modifications in the NEXT Generation
A Phase 4 study testing BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 in people with Trained Immunity and BCG Vaccine, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Non-specific protective effects resulting from the BCG vaccine appear to be paternally inheritable. Since the BCG vaccine is known to induce trained immunity, epigenetics might explain the fathers' contribution to the immune profile of their offspring. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Trained Immunity, BCG Vaccine, Epigenetics
- What is being tested?
- BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Oct 2023to Oct 2024
- Phase
- Phase 4
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Male
- Age 18-25 years (at the moment of trial start)
Who cannot join
- Any systemic disease or conditin, or the use of systemic medication (with the exception of non-threatening alelrgies, e.g. hay fever)
- Smoking or drug use
- Prior BCG vaccination
- Other vaccination four weeks prior to trial start or four weeks after the first study visit (no vaccine in the same arm as the BCG vaccine for three months)
- Acute illness two weeks prior to trial start
- Known allergy or history of anaphylaxis/other serious adverse reaction to any vaccine
- Participation in another drug trial
- Legally incapacitated or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Non-specific protective effects resulting from the BCG vaccine appear to be paternally inheritable. Since the BCG vaccine is known to induce trained immunity, epigenetics might explain the fathers' contribution to the immune profile of their offspring. Epigenetic inheritance in mice has recently been demonstrated, but is not established in humans yet. By studying the DNA methylation profile of sperm cells after BCG vaccination, we aim to gain insight into the possibility of epigenetic inheritance in human males.
- Conditions
- Trained Immunity, BCG Vaccine, Epigenetics
- Being tested
- BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331Biological
Nothing to add
PlaceboBiological
Nothing to add
| Study group | Role | What they receive |
|---|---|---|
| BCG vaccine | Experimental | BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 0.1ml (=0.0075mg) One-time vaccination intradermally Receives: Biological: BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 |
| Placebo vaccine | Placebo comparator | 0.9% NaCl placebo 0.1ml One-time vaccination intradermally Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA methylation profile of sperm cells (first comparison; CHANGE)
Differentially methylated regions (DMRs)
Measured: Comparing T3 to baseline
DNA methylation profile of sperm cells (second comparison; CHANGE)
Differentially methylated regions (DMRs)
Measured: Comparing T4 to baseline
Secondary outcomes (2)
Immunological profile of PBMCs, before and after BCG vaccination (comparison; CHANGE)
Cytokine production assays (e.g. TNFa, IL6, IL1b)
Measured: Comparing T1-T4 to baseline
CHANGE of the epigenetic profile of innate immune cells
Differentially methylated regions (DMRs), ATAC sequencing, RNA sequencing
Measured: Comparing T1-T4 to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start2 Oct 2023
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trained ImmunityStudies 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
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766345
- Sponsor's protocol ID
- 114192
- Other IDs
- 2023-503344-14-00, 2023
- Acronym
- NEXT
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2023
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCG-induced Epigenetic Modifications in the NEXT Generation
- ClinicalTrials.gov ID
- NCT05766345
- Acronym / sponsor ID
- NEXT / 114192
- Conditions
- Trained Immunity, BCG Vaccine, Epigenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Mar 2023 (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.
Non-specific protective effects resulting from the BCG vaccine appear to be paternally inheritable. Since the BCG vaccine is known to induce trained immunity, epigenetics might explain the fathers' contribution to the immune profile of their offspring. Epigenetic inheritance in mice has recently been demonstrated, but is not established in humans yet. By studying the DNA methylation profile of sperm cells after BCG vaccination, we aim to gain insight into the possibility of epigenetic inheritance in human males.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG vaccine | Experimental | Biological: BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 0.1ml (=0.0075mg) One-time vaccination intradermally |
| Placebo vaccine | Placebo comparator | Biological: Placebo0.9% NaCl placebo 0.1ml One-time vaccination intradermally |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Male
- Age 18-25 years (at the moment of trial start)
Key exclusion criteria (8 listed)
- Any systemic disease or conditin, or the use of systemic medication (with the exception of non-threatening alelrgies, e.g. hay fever)
- Smoking or drug use
- Prior BCG vaccination
- Other vaccination four weeks prior to trial start or four weeks after the first study visit (no vaccine in the same arm as the BCG vaccine for three months)
- Acute illness two weeks prior to trial start
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-Vaccine SSI [Statens Serum Institut]) Danish strain 1331Nothing to add | Biological | BCG vaccine |
| PlaceboNothing to add | Biological | Placebo vaccine |
Primary outcome
DNA methylation profile of sperm cells (first comparison; CHANGE)
Time frame: Comparing T3 to baseline
Differentially methylated regions (DMRs)
DNA methylation profile of sperm cells (second comparison; CHANGE)
Time frame: Comparing T4 to baseline
Differentially methylated regions (DMRs)
2 secondary outcomes
Immunological profile of PBMCs, before and after BCG vaccination (comparison; CHANGE)
Time frame: Comparing T1-T4 to baseline
CHANGE of the epigenetic profile of innate immune cells
Time frame: Comparing T1-T4 to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- 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?
A Phase 4 study testing BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 in people with Trained Immunity and BCG Vaccine, 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Apr 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 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. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
DNA methylation profile of sperm cells (first comparison; CHANGE) (time frame: Comparing T3 to baseline). 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?
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 10 Apr 2024.