Status:
UNKNOWN
Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells
Lead Sponsor:
Inmunotek S.L.
Conditions:
Immune Response
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Bacillus Calmette-Guérin (BCG) has been postulated as a strategy to prevent transmission and reduce the incidence of infectious diseases due to its ability to induce trained immunity. However, it is n...
Eligibility Criteria
Inclusion
- 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
- 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 study or during the clinical trial\*.
- Subjects under statins treatment during the last month before inclusion in the clinical trial or during\*.
- \*: these drugs interfere with metabolic pathways involved in trained immunity induction.
- Subjects who are allergic to any of the components included in the flu vaccine.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05208060
Start Date
September 1 2023
End Date
December 31 2025
Last Update
September 19 2024
Active Locations (1)
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1
Hospital Clínico San Carlos
Madrid, Spain, 28040