Evaluating the immune response from a sublingual vaccine called MV130

A Phase I/II Randomized, Prospective, Double-blind, Placebo-controlled, Single-center Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells

This study is testing if a new sublingual vaccine called MV130 can boost the immune response in healthy volunteers to help protect against infections.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Inmunotek S.L. (industry)
• Locations: 1 site (Madrid)
• Trial ID: NCT05208060 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess whether the sublingual vaccine MV130 can induce trained immunity in peripheral blood cells of healthy volunteers. The study focuses on the immunological effects of MV130, which is designed to provide a safer alternative to live-attenuated vaccines like BCG, particularly for vulnerable populations. Participants will receive either MV130 or a placebo, and the trial will evaluate the expression of trained immunity without targeting any specific disease. The findings could contribute to the development of next-generation vaccines that offer broad protection against infectious diseases.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 65 who can comply with the dosing regimen.

Not a fit: Patients who are immunocompromised, pregnant, or breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of safer vaccines that enhance the immune response against infectious diseases.

How similar studies have performed: While the concept of trained immunity is gaining traction, this specific approach with MV130 is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Madrid

• Hospital Clínico San Carlos — Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Silvia Sánchez-Ramón, MD and PhD — Hospital Clinico San Carlos
• Study coordinator: Miguel Casanovas Verges, MD, PhD

Conditions: Immune Response, Trained immunity, Innate immune system, MV130, Sublingual vaccine, Trained immunity-based vaccines