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

Launched by INMUNOTEK S.L. · Jan 12, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a substance called MV130 to see if it can help boost the body's immune response by training immune cells. It's important to note that this study is not looking at how MV130 works for any specific illnesses; instead, it's focused on how it affects healthy volunteers' immune systems. The researchers are currently recruiting healthy adults aged 18 to 65 who can give their consent and follow the study's instructions.

To participate, you'll need to meet certain criteria, such as being in good health, not being pregnant or breastfeeding, and having no significant medical conditions that could interfere with the study. Participants will receive MV130 and will be monitored to understand how their immune system responds. It's also important for potential volunteers to know that they should not be involved in any other clinical trials or have recently received certain vaccinations. If you meet the eligibility requirements, you could help contribute to important research on immune responses!

Gender

ALL

Eligibility criteria

• 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 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.