Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in… (NCT05208060) | Clinical Trial Compass
UnknownPhase 1/2
Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells
Spain48 participantsStarted 2023-09-01
Plain-language summary
A mechanistic clinical trial with the aim to evaluate whether MV130 can induce the expression of a particular immune response (trained immunity) in peripheral blood cells. Therefore, the investigators are not evaluating efficacy in any disease or medical condition but rather assessing the immunological effect in immunogenicity of MV130 in healthy volunteers.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 with a 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-feeding females.
* Subjects who are allergic to any of the components included in MV130.
* Subjects with any concomitant disease or treatment that, according to the investigator criteria, may affect the development of this study, such as immunodeficiencies, malignancies involving bone marrow or lymphoid systems, medical treatment affecting the immune system (including corticosteroids, immunosuppressants, biological agents,…), human immunodeficiency virus, severe allergies, diabetes, hypertension, psychological disorders, etc.
* Subjects who have been vaccinated within 12 months before inclusion (flu or any other vaccine different from COVID-19 vaccine), or who have planned to be vaccinated during the clinical study (excluding the COVID-19 vaccine).
* Subjects who have had an infection that included fever and/or diarrhoea within 3 months before inclusion.
* Subjects under metformin treatment during the last month before inclusion in the clinical s…