Immune ResponsePhase 1/2NCT05208060
Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells
A Phase 1/2 study testing MV130 in people with Immune Response, run by Inmunotek S.L. at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response
- What is being tested?
- MV130
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
Silvia Sánchez-Ramón, MD and PhD, ssramon@salud.madrid.org
About this study
Official title: 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
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.
Read the 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 not recommended to vaccinate with live-attenuated vaccines, such as BCG, to certain vulnerable populations including immunocompromised patients. This issue can be overcome with inactivated preparations that mediate trained immunity such as MV130. The safety of MV130 in pilot studies in patients with immunodeficiency or solid organ recipients, has been highlighted in recent studies.
Based on the principles of trained immunity, it has recently been suggested that this concept can be further exploited in a next generation of anti-infectious vaccines: Trained immunity-based vaccines (TIbV). Thus, these vaccines may confer a broad protection far beyond to the nominal antigens they contain.
- Conditions
- Immune Response
- Being tested
- MV130, Placebo
- Keywords
- Trained immunity, Innate immune system, MV130, Sublingual vaccine, Trained immunity-based vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MV130Biological
Treatment administered sublingually
PlaceboOther
Treatment administered sublingually
| Study group | Role | What they receive |
|---|---|---|
| MV130 | Experimental | Suspension of 6 inactivated whole bacteria concentrates, that contains 90% of Gram positive bacteria (V104 S. pneumoniae 60%, V102 S. aureus 15%, V101 S. epidermidis 15%) and 10% of Gram negative bacteria (V113 K. pneumoniae 4%, V105 M. catarrhalis 3%, V103 H. influenzae 3%), at a concentration of 300 FTU/mL, equivalent to ~ 10^9 bacteria/mL. Receives: Biological: MV130 |
| Placebo | Placebo comparator | Sodium chloride 9 mg/mL and water for injection s.q. f 1 mL. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase ex vivo in cytokine response
The primary outcome is the increase ex vivo in cytokine response (TNF-alfa, IL-6 and/or IL-1beta) in PBMCs upon secondary restimulation (MV130, lipopolysaccharide [LPS], inactivated Candida albicans, Resiquimod-R848, Poly I:C and/or phytohemagglutinin [PHA]) in MV130 vaccinated subjects compared to placebo group, at days 15, 45 and/or 70, with respect to baseline.
Measured: 70 days
Secondary outcomes (13)
Epigenetic and metabolic changes in purified monocytes from PBMCs, in a subgroup of MV130 vaccinated (n=12) versus placebo (n=12), at day 45 with respect to baseline.
It includes specific miRNA associated to trained immunity (miR155, miR146 and/or miR21, etc.) and histone marks (H3K4me3 and/or H3K27me3, among others), as epigenetic rewiring markers.
It also includes lactate production, glucose consumption and mitochondrial activity as metabolic changes.
Measured: 70 days
Changes in percentages of immune populations in peripheral blood including T and B cells, NK cells and subsets of monocytes, in MV130 group compared to placebo at days 15, 45 and/or 70, with respect to baseline.
Changes in percentages of immune populations in peripheral blood including T and B cells, NK cells and subsets of monocytes, in MV130 group compared to placebo at days 15, 45 and/or 70, with respect to baseline.
Measured: 70 days
Change in MV130 non-specific response (T and B cells from PBMCs) in MV130 treated group compared to placebo.
It includes T cell proliferation (days 15, 45 and/or 70) by labelling T cells with carboxyfluorescein succinimidyl ester (CFSE) prior to restimulation with PHA, inactivated C. albicans and flu antigens. Also, change of cytokine production (such as IFN-gamma, IL-17 and/or IL-10) from T cells upon restimulation (LPS, inactivated Candida albicans, flu antigens and/or PHA) (days 15, 45 and/or 70 with respect to baseline).
It also includes antibody production: cross-reactive serum IgG against viral components. Different viral proteins/peptides will be tested (days 45 and 70 with respect to baseline). Antibody responses against flu antigens (IgG and IgA in serum and IgA in saliva) will be evaluated (days 45 and 70 with respect to baseline).
Measured: 70 days
MV130 specific response (T and B cells responses form PBMCs) in MV130 vaccinated group compared to placebo.
It includes T cell proliferation and cytokine production (IFN-gamma, IL-17 and/or IL-10) following restimulation with MV130 (days 15, 45 and/or 70 with respect to baseline).
It also includes antibody production: MV130 specific IgG and IgA levels in serum and IgA levels in saliva (days 45 and/or 70 with respect to baseline). Individual bacteria contained in MV130 (i.e., S. pneumoniae) will be further tested for specific antibody production.
Measured: 70 days
Change in baseline oral microbiota composition in MV130 treated group (days 45 and 70 with respect to baseline) compared to placebo, based on the 16S rRNA sequence phylogeny.
Change in baseline oral microbiota composition in MV130 treated group (days 45 and 70 with respect to baseline) compared to placebo, based on the 16S rRNA sequence phylogeny.
Measured: 70 days
Rates of adverse events
The overall rate of adverse events in both groups
Measured: 70 days
Classification of the Adverse events
Classification of the Adverse events during the trial
Measured: 70 days
Rates of adverse reactions
The overall rate of adverse reactions in both groups
Measured: 70 days
Classification of the Adverse reactions
Classification of the Adverse reactions during the trial
Measured: 70 days
Percentage by type of adverse events
Percentage by type of adverse events occurred during the trial
Measured: 70 days
Percentage of subject with adverse reactions
Percentage of subject experiencing adverse reactions during the trial
Measured: 70 days
Timing of reaction appearance
Time from the first administration to appearance of the reaction
Measured: 70 days
Classification of the adverse reaction according to the place of appearance
Classification of the adverse reaction in local or systemic, depending on the place of appearance
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Sep 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- More trials run by Inmunotek S.L.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silvia Sánchez-Ramón, MD and PhD, Principal investigator, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208060
- Sponsor's protocol ID
- MV130-SLG-039
- Status last verified
- Sep 2023
- First submitted
- 13 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
PubMed 32132681Sanchez-Ramon S, Conejero L, Netea MG, Sancho D, Palomares O, Subiza JL. Trained Immunity-Based Vaccines: A New Paradigm for the Development of Broad-Spectrum Anti-infectious Formulations. Front Immunol. 2018 Dec 17;9:2936. doi: 10.3389/fimmu.2018.02936. eCollection 2018.
PubMed 30619296Guevara-Hoyer K, Saz-Leal P, Diez-Rivero CM, Ochoa-Grullon J, Fernandez-Arquero M, Perez de Diego R, Sanchez-Ramon S. Trained Immunity Based-Vaccines as a Prophylactic Strategy in Common Variable Immunodeficiency. A Proof of Concept Study. Biomedicines. 2020 Jul 9;8(7):203. doi: 10.3390/biomedicines8070203.
PubMed 32660100Alecsandru D, Valor L, Sanchez-Ramon S, Gil J, Carbone J, Navarro J, Rodriguez J, Rodriguez-Sainz C, Fernandez-Cruz E. Sublingual therapeutic immunization with a polyvalent bacterial preparation in patients with recurrent respiratory infections: immunomodulatory effect on antigen-specific memory CD4+ T cells and impact on clinical outcome. Clin Exp Immunol. 2011 Apr;164(1):100-7. doi: 10.1111/j.1365-2249.2011.04320.x.
PubMed 21391984Garcia Gonzalez LA, Arrutia Diez F. Mucosal bacterial immunotherapy with MV130 highly reduces the need of tonsillectomy in adults with recurrent tonsillitis. Hum Vaccin Immunother. 2019;15(9):2150-2153. doi: 10.1080/21645515.2019.1581537. Epub 2019 Apr 17.
PubMed 30779677Nieto A, Mazon A, Nieto M, Calderon R, Calaforra S, Selva B, Uixera S, Palao MJ, Brandi P, Conejero L, Saz-Leal P, Fernandez-Perez C, Sancho D, Subiza JL, Casanovas M. Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Aug 15;204(4):462-472. doi: 10.1164/rccm.202003-0520OC.
PubMed 33705665Cirauqui C, Benito-Villalvilla C, Sanchez-Ramon S, Sirvent S, Diez-Rivero CM, Conejero L, Brandi P, Hernandez-Cillero L, Ochoa JL, Perez-Villamil B, Sancho D, Subiza JL, Palomares O. Human dendritic cells activated with MV130 induce Th1, Th17 and IL-10 responses via RIPK2 and MyD88 signalling pathways. Eur J Immunol. 2018 Jan;48(1):180-193. doi: 10.1002/eji.201747024. Epub 2017 Sep 14.
PubMed 28799230Vazquez A, Fernandez-Sevilla LM, Jimenez E, Perez-Cabrera D, Yanez R, Subiza JL, Varas A, Valencia J, Vicente A. Involvement of Mesenchymal Stem Cells in Oral Mucosal Bacterial Immunotherapy. Front Immunol. 2020 Nov 19;11:567391. doi: 10.3389/fimmu.2020.567391. eCollection 2020.
PubMed 33329530Del Fresno C, Garcia-Arriaza J, Martinez-Cano S, Heras-Murillo I, Jarit-Cabanillas A, Amores-Iniesta J, Brandi P, Dunphy G, Suay-Corredera C, Pricolo MR, Vicente N, Lopez-Perrote A, Cabezudo S, Gonzalez-Corpas A, Llorca O, Alegre-Cebollada J, Garaigorta U, Gastaminza P, Esteban M, Sancho D. The Bacterial Mucosal Immunotherapy MV130 Protects Against SARS-CoV-2 Infection and Improves COVID-19 Vaccines Immunogenicity. Front Immunol. 2021 Nov 18;12:748103. doi: 10.3389/fimmu.2021.748103. eCollection 2021.
PubMed 34867974Ochoa-Grullon J, Benavente Cuesta C, Gonzalez Fernandez A, Cordero Torres G, Perez Lopez C, Pena Cortijo A, Conejero Hall L, Mateo Morales M, Rodriguez de la Pena A, Diez-Rivero CM, Rodriguez de Frias E, Guevara-Hoyer K, Fernandez-Arquero M, Sanchez-Ramon S. Trained Immunity-Based Vaccine in B Cell Hematological Malignancies With Recurrent Infections: A New Therapeutic Approach. Front Immunol. 2021 Feb 12;11:611566. doi: 10.3389/fimmu.2020.611566. eCollection 2020.
PubMed 33679698Molero-Abraham M, Sanchez-Trincado JL, Gomez-Perosanz M, Torres-Gomez A, Subiza JL, Lafuente EM, Reche PA. Human Oral Epithelial Cells Impair Bacteria-Mediated Maturation of Dendritic Cells and Render T Cells Unresponsive to Stimulation. Front Immunol. 2019 Jun 28;10:1434. doi: 10.3389/fimmu.2019.01434. eCollection 2019.
PubMed 31316504
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05208060
- Acronym / sponsor ID
- MV130-SLG-039
- Conditions
- Immune Response
- Keywords
- Trained immunity, Innate immune system, MV130, Sublingual vaccine, Trained immunity-based vaccines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 not recommended to vaccinate with live-attenuated vaccines, such as BCG, to certain vulnerable populations including immunocompromised patients. This issue can be overcome with inactivated preparations that mediate trained immunity such as MV130. The safety of MV130 in pilot studies in patients with immunodeficiency or solid organ recipients, has been highlighted in recent studies.
Based on the principles of trained immunity, it has recently been suggested that this concept can be further exploited in a next generation of anti-infectious vaccines: Trained immunity-based vaccines (TIbV). Thus, these vaccines may confer a broad protection far beyond to the nominal antigens they contain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MV130 | Experimental | Biological: MV130Suspension of 6 inactivated whole bacteria concentrates, that contains 90% of Gram positive bacteria (V104 S. pneumoniae 60%, V102 S. aureus 15%, V101 S. epidermidis 15%) and 10% of Gram negative bacteria (V113 K. pneumoniae 4%, V105 M. catarrhalis 3%, V103 H. influenzae 3%), at a concentration of 300 FTU/mL, equivalent to ~ 10^9 bacteria/mL. |
| Placebo | Placebo comparator | Other: PlaceboSodium chloride 9 mg/mL and water for injection s.q. f 1 mL. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MV130Treatment administered sublingually | Biological | MV130 |
| PlaceboTreatment administered sublingually | Other | Placebo |
Primary outcome
Increase ex vivo in cytokine response
Time frame: 70 days
The primary outcome is the increase ex vivo in cytokine response (TNF-alfa, IL-6 and/or IL-1beta) in PBMCs upon secondary restimulation (MV130, lipopolysaccharide [LPS], inactivated Candida albicans, Resiquimod-R848, Poly I:C and/or phytohemagglutinin [PHA]) in MV130 vaccinated subjects compared to placebo group, at days 15, 45 and/or 70, with respect to baseline.
13 secondary outcomes
Epigenetic and metabolic changes in purified monocytes from PBMCs, in a subgroup of MV130 vaccinated (n=12) versus placebo (n=12), at day 45 with respect to baseline.
Time frame: 70 days
Changes in percentages of immune populations in peripheral blood including T and B cells, NK cells and subsets of monocytes, in MV130 group compared to placebo at days 15, 45 and/or 70, with respect to baseline.
Time frame: 70 days
Change in MV130 non-specific response (T and B cells from PBMCs) in MV130 treated group compared to placebo.
Time frame: 70 days
MV130 specific response (T and B cells responses form PBMCs) in MV130 vaccinated group compared to placebo.
Time frame: 70 days
Change in baseline oral microbiota composition in MV130 treated group (days 45 and 70 with respect to baseline) compared to placebo, based on the 16S rRNA sequence phylogeny.
Time frame: 70 days
Rates of adverse events
Time frame: 70 days
Classification of the Adverse events
Time frame: 70 days
Rates of adverse reactions
Time frame: 70 days
Classification of the Adverse reactions
Time frame: 70 days
Percentage by type of adverse events
Time frame: 70 days
Percentage of subject with adverse reactions
Time frame: 70 days
Timing of reaction appearance
Time frame: 70 days
Classification of the adverse reaction according to the place of appearance
Time frame: 70 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 32132681Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
- Background: PubMed 30619296Sanchez-Ramon S, Conejero L, Netea MG, Sancho D, Palomares O, Subiza JL. Trained Immunity-Based Vaccines: A New Paradigm for the Development of Broad-Spectrum Anti-infectious Formulations. Front Immunol. 2018 Dec 17;9:2936. doi: 10.3389/fimmu.2018.02936. eCollection 2018.
- Background: PubMed 32660100Guevara-Hoyer K, Saz-Leal P, Diez-Rivero CM, Ochoa-Grullon J, Fernandez-Arquero M, Perez de Diego R, Sanchez-Ramon S. Trained Immunity Based-Vaccines as a Prophylactic Strategy in Common Variable Immunodeficiency. A Proof of Concept Study. Biomedicines. 2020 Jul 9;8(7):203. doi: 10.3390/biomedicines8070203.
- Background: PubMed 21391984Alecsandru D, Valor L, Sanchez-Ramon S, Gil J, Carbone J, Navarro J, Rodriguez J, Rodriguez-Sainz C, Fernandez-Cruz E. Sublingual therapeutic immunization with a polyvalent bacterial preparation in patients with recurrent respiratory infections: immunomodulatory effect on antigen-specific memory CD4+ T cells and impact on clinical outcome. Clin Exp Immunol. 2011 Apr;164(1):100-7. doi: 10.1111/j.1365-2249.2011.04320.x.
- Background: PubMed 30779677Garcia Gonzalez LA, Arrutia Diez F. Mucosal bacterial immunotherapy with MV130 highly reduces the need of tonsillectomy in adults with recurrent tonsillitis. Hum Vaccin Immunother. 2019;15(9):2150-2153. doi: 10.1080/21645515.2019.1581537. Epub 2019 Apr 17.
- Background: PubMed 33705665Nieto A, Mazon A, Nieto M, Calderon R, Calaforra S, Selva B, Uixera S, Palao MJ, Brandi P, Conejero L, Saz-Leal P, Fernandez-Perez C, Sancho D, Subiza JL, Casanovas M. Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Aug 15;204(4):462-472. doi: 10.1164/rccm.202003-0520OC.
- Background: PubMed 28799230Cirauqui C, Benito-Villalvilla C, Sanchez-Ramon S, Sirvent S, Diez-Rivero CM, Conejero L, Brandi P, Hernandez-Cillero L, Ochoa JL, Perez-Villamil B, Sancho D, Subiza JL, Palomares O. Human dendritic cells activated with MV130 induce Th1, Th17 and IL-10 responses via RIPK2 and MyD88 signalling pathways. Eur J Immunol. 2018 Jan;48(1):180-193. doi: 10.1002/eji.201747024. Epub 2017 Sep 14.
- Background: PubMed 33329530Vazquez A, Fernandez-Sevilla LM, Jimenez E, Perez-Cabrera D, Yanez R, Subiza JL, Varas A, Valencia J, Vicente A. Involvement of Mesenchymal Stem Cells in Oral Mucosal Bacterial Immunotherapy. Front Immunol. 2020 Nov 19;11:567391. doi: 10.3389/fimmu.2020.567391. eCollection 2020.
- Background: PubMed 34867974Del Fresno C, Garcia-Arriaza J, Martinez-Cano S, Heras-Murillo I, Jarit-Cabanillas A, Amores-Iniesta J, Brandi P, Dunphy G, Suay-Corredera C, Pricolo MR, Vicente N, Lopez-Perrote A, Cabezudo S, Gonzalez-Corpas A, Llorca O, Alegre-Cebollada J, Garaigorta U, Gastaminza P, Esteban M, Sancho D. The Bacterial Mucosal Immunotherapy MV130 Protects Against SARS-CoV-2 Infection and Improves COVID-19 Vaccines Immunogenicity. Front Immunol. 2021 Nov 18;12:748103. doi: 10.3389/fimmu.2021.748103. eCollection 2021.
- Background: PubMed 33679698Ochoa-Grullon J, Benavente Cuesta C, Gonzalez Fernandez A, Cordero Torres G, Perez Lopez C, Pena Cortijo A, Conejero Hall L, Mateo Morales M, Rodriguez de la Pena A, Diez-Rivero CM, Rodriguez de Frias E, Guevara-Hoyer K, Fernandez-Arquero M, Sanchez-Ramon S. Trained Immunity-Based Vaccine in B Cell Hematological Malignancies With Recurrent Infections: A New Therapeutic Approach. Front Immunol. 2021 Feb 12;11:611566. doi: 10.3389/fimmu.2020.611566. eCollection 2020.
- Background: PubMed 31316504Molero-Abraham M, Sanchez-Trincado JL, Gomez-Perosanz M, Torres-Gomez A, Subiza JL, Lafuente EM, Reche PA. Human Oral Epithelial Cells Impair Bacteria-Mediated Maturation of Dendritic Cells and Render T Cells Unresponsive to Stimulation. Front Immunol. 2019 Jun 28;10:1434. doi: 10.3389/fimmu.2019.01434. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Sánchez-Ramón, MD and PhD principal investigator
Hospital Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MV130 in people with Immune Response, run by Inmunotek S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Casanovas Verges, MD, PhD (664277223, mcasanovas@inmunotek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase ex vivo in cytokine response (time frame: 70 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05208060, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.