To study the possible epigenetic modifications in sperm cells after BCG vaccination
ID
Source
Brief title
Condition
- Infections - pathogen unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the change in DNA methylation signatures of sperm cells in
the intervention group, from
baseline to 3 and 6 months after BCG vaccination, in comparison to a
placebo-treated group
Secondary outcome
Functional assessment of immune cell populations in both groups, at all
timepoints.
Background summary
Non-specific protective effects against infections and overall mortality
induced by the BCG vaccination have been
recently proposed to be inheritable. Since the BCG vaccine is known to induce
trained immunity, epigenetic
reprogramming of sperm cells 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
investigate the possibility of cross-generational transmission of resistance to
infection in humans through epigenetic reprogramming
Study objective
To study the possible epigenetic modifications in sperm cells after BCG
vaccination
Study design
The NEXT study is a single-blind, randomized placebo-controlled trial.
Participants will take part in five study visits
over a period of six months, where samples of blood and sperm cells will be
collected.
Intervention
Participants will be randomized 1:1 to receive either a BCG vaccine or a
placebo, administered intradermally. After
this intervention, four more study visits will take place to monitor adverse
events and collect samples
Study burden and risks
This trial does not include groups that are considered vulnerable. The risks to
participants are very low, as the used
vaccine has a well-established safety profile in all age groups, with mainly
locally, mild and spontaneously resolving
side-effects. Although venous puncture has some risks (e.g. formation of a
hematoma), these are considered
negligible. The amount of blood drawn (300ml in 6 months) is not expected to
have any negative consequences.
Collection of sperm cells can be done in the privacy of the participants* own
home.
An import detail is that oligo/azoospermia might be discovered. This will be
discussed with the concerning participant, but is likely to be burdensome and
emotional.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Male
18-25 years old
Healthy
Exclusion criteria
Any systemic disease or condition, or the use of systemic medication
Smoking
Prior BCG vaccination
Other vaccination four weeks prior to trial start or four weeks after the first
study visit
Acute illness 2 weeks prior to trial start
Known allergy or anaphylaxis/serious adverse reaction to any vaccine
Participation in another drug trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05766345 |
| CCMO | NL84471.091.23 |