Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells

Inclusion Criteria:

• Subjects that have provided written informed consent.

• Healthy males and females 18 to 65 years, both included, at the time of enrolment.

• Subjects who are able to provide cooperation and comply with dosing regimen.

• Women of childbearing age (from menarche) should submit a urine pregnancy test witha negative result at the time of enrolment in the trial.

Exclusion Criteria:

• Simultaneous participation in another clinical trial.

• Females who are pregnant or breast-feeding, or potential pregnant or breast-feedingfemales.

• Subjects who are allergic to any of the components included in MV130.

• Subjects with any concomitant disease or treatment that, according to theinvestigator criteria, may affect the development of this study, such asimmunodeficiencies, malignancies involving bone marrow or lymphoid systems, medicaltreatment affecting the immune system (including corticosteroids,immunosuppressants, biological agents,...), human immunodeficiency virus, severeallergies, diabetes, hypertension, psychological disorders, etc.

• Subjects who have been vaccinated within 12 months before inclusion (flu or anyother vaccine different from COVID-19 vaccine), or who have planned to be vaccinatedduring the clinical study (excluding the COVID-19 vaccine).

• Subjects who have had an infection that included fever and/or diarrhoea within 3months before inclusion.

• Subjects under metformin treatment during the last month before inclusion in theclinical study or during the clinical trial*.

• Subjects under statins treatment during the last month before inclusion in theclinical trial or during*.

*: these drugs interfere with metabolic pathways involved in trained immunityinduction.

• Subjects who are allergic to any of the components included in the flu vaccine.