Chronic Obstructive Pulmonary Disease (COPD)Phase 2/3MV130NCT01842360
Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2/3 study testing MV130 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Inmunotek S.L. at 7 sites in Spain.
Trial summary
The goal of this clinical trial is to learn whether the bacterial vaccine MV130 helps reduce the number of exacerbations in adults with moderate to severe COPD. It will also assess the safety and immune effects of MV130. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- MV130
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 7 sitesSpain
- Study dates
- 6 May 2013to 2 Aug 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Both sexes.
- Age between 35 and 85.
- Must be capable of complying with the dosing regimen.
- Diagnosis of moderate or severe COPD according to GOLD criteria.
- Experienced at least three moderate exacerbations (i.e., those requiring treatment with antibiotics, systemic corticosteroids, or both, as prescribed by their general practitioner or pulmonologist in the standard consultation and/or the Emergency Department of their Clinic) or two exacerbations with at least one requiring hospitalization due to a COPD exacerbation and the other one a moderate exacerbation occurred within the last year.
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- Not changed their medication for the maintenance treatment of COPD within the past 6 months.
- Consumption of 10 or more packs of cigarettes/year. Participants may be or not active smokers.
- Live in the Autonomous Community of Madrid throughout the study period.
- Women of childbearing age women of must use an approved contraceptive method and obtain a negative result in the urine pregnancy test performed during the screening visit.
Who cannot join
- Participants outside allowed age range.
- Participants unable to cooperate and/or have a severe psychiatric disorder.
- Women who are pregnant, breastfeeding, expect to become pregnant during the study (including assisted reproduction), or who refuse to use contraceptives during the study (including barrier methods). Women who become pregnant during the clinical trial will have to discontinue their participation in it.
- Participants who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion.
- Participants diagnosed with asthma based on the guidelines of the American Thoracic Society and the European Respiratory Society. If the investigators are unable to differentiate between COPD and asthma after applying the criteria listed in the following table, a bronchodilator test with inhaled salbutamol must be performed, excluding those subjects with FEV1 changes >400 ml.
- Participants with a diagnosis other than COPD that causes them to have an unstable condition or a life expectancy <3 years.
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- Participants who had an exacerbation within 4 weeks before starting the trial.
- Participants with moderate COPD who required treatment with inhaled corticosteroids in the last 4 weeks.
- Participants with moderate COPD who received systemic corticosteroids (orally, intramuscularly, or intravenously) in the last 4 weeks.
- Participants diagnosed with a Primary or Secondary Immunodeficiency within the 12 months preceding their inclusion in the clinical trial or the trial's baseline visit.
- Participants diagnosed with chronic lymphoproliferative disease.
- Participants diagnosed with chronic infectious disease.
- Participants with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
- Participants diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa.
- Participants with COPD and bronchiectasis diagnosed by CT imaging before the age of 40.
- Participants diagnosed with very severe COPD according to the GOLD classification.
- Participants requiring home oxygen therapy or non-invasive mechanical ventilation.
- Participants with a history of hypersensitivity to any of the vaccine's components.
- Participants receiving immunosuppressive treatment with: azathioprine, methotrexate, ciclosporin, cyclophosphamide, tacrolimus, antimalarial drugs, or gold salts.
- Participants who have been treated with monoclonal antibodies such as rituximab or TNF-alpha inhibitors in the last 6 months.
- Participants receiving chronic treatment with azithromycin or inhaled antibiotics (tobramycin or colistin).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, 28850
Hospital Universitario de Vic
Vic, Barcelona, 08500
About this study
Official title: Randomized Double-blind Placebo-controlled Multicenter Clinical Trial of Bacterial Polyvalent Vaccine (BACTEK®), Administered Sublingually in COPD Patients, to Evaluate Efficacy, Safety, and Immunomodulatory Response.
The goal of this clinical trial is to learn whether the bacterial vaccine MV130 helps reduce the number of exacerbations in adults with moderate to severe COPD. It will also assess the safety and immune effects of MV130. The main questions it aims to answer is: Does MV130 lower the number and severity of COPD flare-ups? Other questions include: Does it reduce the use of healthcare resources and improve quality of life?
Researchers will compare MV130 to a placebo (a similar spray without the active substance; bacterial species) to see how well it works. Participants will use either MV130 or placebo daily under the tongue for 12 months, attend regular clinic visits, and be followed for an additional 6 months to monitor health outcomes and side effects.
Read the detailed description
This was a randomized, double-blind, placebo-controlled, prospective, parallel, multicenter clinical trial designed to evaluate the efficacy, safety, and immunomodulatory effects of a sublingually administered bacterial polyvalent vaccine (BACTEK®, also known as MV130) in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study was conducted by Inmunotek, S.L., and included seven sHospitals across Spain. A total of 198 participants were enrolled and randomized equally into two groups to receive either MV130 or placebo over a period of 12 months, followed by a 6-month observation phase, totaling 18 months of participation per participant.
The investigational product, MV130, consisted of a glycerinated suspension containing six inactivated non-lysate bacterial species: Streptococcus pneumoniae, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae. The product was administered sublingually at a dosage of two sprays (0.2 mL total) per day. The placebo formulation was identical in appearance and composition, excluding the active bacterial components. All study participants received their first dose under supervision at the clinical site and were trained for home administration.
Eligible participants were between 35 and 85 years old, with a diagnosis of moderate or severe COPD according to GOLD guidelines, a history of recurrent exacerbations (≥3 moderate or ≥2 with at least one hospitalization in the past year), and a smoking history of at least 10 pack-years. Subjects were excluded if they had very severe COPD, a history of recent exacerbations or systemic corticosteroid use, concurrent immunodeficiency or serious comorbid conditions, or if they were pregnant, breastfeeding, or unwilling to use contraception during the study.
The primary efficacy endpoint was the total number of COPD exacerbations during the full 18-month period. Secondary endpoints included the severity of exacerbations, time to first exacerbation, healthcare resource usage (hospitalizations, emergency room visits, unscheduled consultations), medication use, health-related quality of life (assessed using the CAT questionnaire), and a pharmacoeconomic evaluation based on healthcare expenditures. In a subset of participants, immunological parameters were also assessed to explore the immunomodulatory response. Safety analysis included all randomized participants.
- Being tested
- Placebo, MV130
- Keywords
- Vaccine, Chronic obstructive pulmonary disease (COPD), Exacerbations, Prevention, Sublingual
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
The participants will receive daily dose of placebo during 12 months sublingually.
MV130Biological
The participants will receive daily dose of MV130 during 12 months sublingually.
| Study group | Role | What they receive |
|---|---|---|
| Active - MV130 | Experimental | The participants will receive daily dose of MV130 during 12 months sublingually. Receives: Biological: MV130 |
| Placebo | Placebo comparator | The participants will receive daily dose of placebo during 12 months sublingually. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of COPD Exacerbations.
Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.
Measured: 18 months
Secondary outcomes (11)
Change in the Rate of COPD Exacerbations.
Incidence is the number of new events per total participants in the sample population.
Measured: 18 months
Change in Severity of COPD Exacerbations.
The severity of exacerbations was to be measured by the consumption of health care resources:
Emergency Department/Hospitalisation/Intensive Care Unit/Consultations visits, as follows:
ICU hospitalisation 4 points Hospitalisation 3 points Emergency room visit 2 points Consultation resulting in change in usual treatment 1 point
Measured: 18 months
Time Elapsed Between Start of Treatment and First COPD Exacerbation.
For reference, median survival or event-free times are reported with the 95% CI of the median.
Measured: 18 months
Use of Drugs (Antibiotics, Corticosteroids, Etc).
The use of drugs will be calculated using the following index:
- antibiotics: 1 point
- inhaled corticosteroids: 2 points
- systemic corticosteroids: 3 points
Measured: 18 months
Number of Hospitalizations Due to a COPD Exacerbation.
The same patient could have more than one hospitalizations.
Measured: 18 months
Days of Hospitalization Due to a COPD Exacerbation.
Number of days of hospitalization per patient were recorded. The same patient could have more than one hospitalization.
Measured: 18 months
Number of Visits to the Emergency Room.
Number of individual visits were recorded per patient. One patient could have multiple visits.
Measured: 18 months
Number of Unscheduled Medical Consultations Due to COPD
Number of consultations per patient. One patient could have multiple consultations.
Measured: 18 months.
Health Related Quality of Life.
COPD Assessment Test per patient determined by an adapted version of the specific COPD Assessment Test. Minimum value is 0 (better) and maximum value is 40 (worse). The change between two or more time points is reported. Change between baseline and 18 months in shown.
Measured: 18 months
Healthcare Resource Utilization During COPD Exacerbations
Healthcare resource utilization was assessed as the sum of:
- Complementary tests
- Programmed visits to the specialist
- Total number of visits to the specialist
- Non-programmed visits to the specialist
- ICU hospitalization days
- Visits to the emergency room
- Days hospitalized
- Sum of antibiotics
- Number of visits to General Practitioner
- Sum of oral corticosteroids
- Number of telephone calls to the GP
- Sum of inhalers
- Home visits
- Sum of antipyretics
Total number of healthcare resources used during COPD exacerbation episodes. Data were summarized per treatment group and reported as total counts and percent differences. No baseline or monetary data were collected
Measured: 18 months
Adverse Events and Overall Tolerability (Adverse Reactions).
Total number of adverse events in Active (MV130) and Placebo groups were compared.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study start6 May 2013
- Primary completion29 Jul 2019
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo Fernández Cruz, MD, PhD, Study director, Hospital General Universitario Gregorio MarañonJavier de Miguel Díez, MD, PhD, Principal investigator, Hospital General Universitario Gregorio MarañonJosé Luis Álvarez-Sala, MD, PhD, Principal investigator, Hospital San Carlos, MadridMaría J Buendía, MD, Principal investigator, Hospital Universitario Infanta LeonorCarlos J Álvarez, MD, PhD, Principal investigator, Hospital Universitario 12 de OctubreSoledad Alonso, MD, Principal investigator, Hospital Universitario de Torrejón, MadridFrancisco García, MD, PhD, Principal investigator, Hospital Universitario La PazJoan Serra, MD, Principal investigator, Hospital de Universitario Vic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842360
- Sponsor's protocol ID
- MV130-SLG-001
- Other IDs
- 2012-003253-28
- Acronym
- MV130
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2013
- Last updated
- 2 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maestu LP, Rubio MC, Benedetti P, Matute WIG, Hermosa JLR, Alvarez-Sala JL, Martinez CJA, Garcia MJB, Battles JS, Rio FG, de Pedro JG, Fernandez-Perez C, Rodriguez-Sainz C, Perez JG, de Miguel Diez J, Caballero R, Casanovas M, Subiza JL, Fernandez-Cruz E. Prevention of COPD exacerbations with a mucosal trained immunity-based vaccine (MV130): a randomised phase 3 trial. Eur Respir J. 2026 Jul 23:2600027. doi: 10.1183/13993003.00027-2026. Online ahead of print.
PubMed 42492956
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo-controlled Multicenter Clinical Trial of Bacterial Polyvalent Vaccine (BACTEK®), Administered Sublingually in COPD Patients, to Evaluate Efficacy, Safety, and Immunomodulatory Response.
- ClinicalTrials.gov ID
- NCT01842360
- Acronym / sponsor ID
- MV130 / MV130-SLG-001
- Keywords
- Vaccine, Chronic obstructive pulmonary disease (COPD), Exacerbations, Prevention, Sublingual
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- 6 May 2013 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Posted 2 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether the bacterial vaccine MV130 helps reduce the number of exacerbations in adults with moderate to severe COPD. It will also assess the safety and immune effects of MV130. The main questions it aims to answer is: Does MV130 lower the number and severity of COPD flare-ups? Other questions include: Does it reduce the use of healthcare resources and improve quality of life?
Researchers will compare MV130 to a placebo (a similar spray without the active substance; bacterial species) to see how well it works. Participants will use either MV130 or placebo daily under the tongue for 12 months, attend regular clinic visits, and be followed for an additional 6 months to monitor health outcomes and side effects.
Detailed description
This was a randomized, double-blind, placebo-controlled, prospective, parallel, multicenter clinical trial designed to evaluate the efficacy, safety, and immunomodulatory effects of a sublingually administered bacterial polyvalent vaccine (BACTEK®, also known as MV130) in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study was conducted by Inmunotek, S.L., and included seven sHospitals across Spain. A total of 198 participants were enrolled and randomized equally into two groups to receive either MV130 or placebo over a period of 12 months, followed by a 6-month observation phase, totaling 18 months of participation per participant.
The investigational product, MV130, consisted of a glycerinated suspension containing six inactivated non-lysate bacterial species: Streptococcus pneumoniae, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae. The product was administered sublingually at a dosage of two sprays (0.2 mL total) per day. The placebo formulation was identical in appearance and composition, excluding the active bacterial components. All study participants received their first dose under supervision at the clinical site and were trained for home administration.
Eligible participants were between 35 and 85 years old, with a diagnosis of moderate or severe COPD according to GOLD guidelines, a history of recurrent exacerbations (≥3 moderate or ≥2 with at least one hospitalization in the past year), and a smoking history of at least 10 pack-years. Subjects were excluded if they had very severe COPD, a history of recent exacerbations or systemic corticosteroid use, concurrent immunodeficiency or serious comorbid conditions, or if they were pregnant, breastfeeding, or unwilling to use contraception during the study.
The primary efficacy endpoint was the total number of COPD exacerbations during the full 18-month period. Secondary endpoints included the severity of exacerbations, time to first exacerbation, healthcare resource usage (hospitalizations, emergency room visits, unscheduled consultations), medication use, health-related quality of life (assessed using the CAT questionnaire), and a pharmacoeconomic evaluation based on healthcare expenditures. In a subset of participants, immunological parameters were also assessed to explore the immunomodulatory response. Safety analysis included all randomized participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active - MV130 | Experimental | Biological: MV130The participants will receive daily dose of MV130 during 12 months sublingually. |
| Placebo | Placebo comparator | Biological: PlaceboThe participants will receive daily dose of placebo during 12 months sublingually. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent.
- Both sexes.
- Age between 35 and 85.
- Must be capable of complying with the dosing regimen.
- Diagnosis of moderate or severe COPD according to GOLD criteria.
Key exclusion criteria (21 listed)
- Participants outside allowed age range.
- Participants unable to cooperate and/or have a severe psychiatric disorder.
- Women who are pregnant, breastfeeding, expect to become pregnant during the study (including assisted reproduction), or who refuse to use contraceptives during the study (including barrier methods). Women who become pregnant during the clinical trial will have to discontinue their participation in it.
- Participants who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion.
- Participants diagnosed with asthma based on the guidelines of the American Thoracic Society and the European Respiratory Society. If the investigators are unable to differentiate between COPD and asthma after applying the criteria listed in the following table, a bronchodilator test with inhaled salbutamol must be performed, excluding those subjects with FEV1 changes >400 ml.
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 |
|---|---|---|
| PlaceboThe participants will receive daily dose of placebo during 12 months sublingually. | Biological | Placebo |
| MV130The participants will receive daily dose of MV130 during 12 months sublingually. | Biological | Active - MV130 |
Primary outcome
Number of COPD Exacerbations.
Time frame: 18 months
Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.
11 secondary outcomes
Change in the Rate of COPD Exacerbations.
Time frame: 18 months
Change in Severity of COPD Exacerbations.
Time frame: 18 months
Time Elapsed Between Start of Treatment and First COPD Exacerbation.
Time frame: 18 months
Use of Drugs (Antibiotics, Corticosteroids, Etc).
Time frame: 18 months
Number of Hospitalizations Due to a COPD Exacerbation.
Time frame: 18 months
Days of Hospitalization Due to a COPD Exacerbation.
Time frame: 18 months
Number of Visits to the Emergency Room.
Time frame: 18 months
Number of Unscheduled Medical Consultations Due to COPD
Time frame: 18 months.
Health Related Quality of Life.
Time frame: 18 months
Healthcare Resource Utilization During COPD Exacerbations
Time frame: 18 months
Adverse Events and Overall Tolerability (Adverse Reactions).
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42492956Maestu LP, Rubio MC, Benedetti P, Matute WIG, Hermosa JLR, Alvarez-Sala JL, Martinez CJA, Garcia MJB, Battles JS, Rio FG, de Pedro JG, Fernandez-Perez C, Rodriguez-Sainz C, Perez JG, de Miguel Diez J, Caballero R, Casanovas M, Subiza JL, Fernandez-Cruz E. Prevention of COPD exacerbations with a mucosal trained immunity-based vaccine (MV130): a randomised phase 3 trial. Eur Respir J. 2026 Jul 23:2600027. doi: 10.1183/13993003.00027-2026. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Eduardo Fernández Cruz, MD, PhD study director
Hospital General Universitario Gregorio Marañon
Javier de Miguel Díez, MD, PhD principal investigator
Hospital General Universitario Gregorio Marañon
José Luis Álvarez-Sala, MD, PhD principal investigator
Hospital San Carlos, Madrid
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MV130 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Inmunotek S.L. at 7 sites 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 10 inclusion and 21 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: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of COPD Exacerbations. (time frame: 18 months). 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 NCT01842360, which also lists 1 linked publication.
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 2 Oct 2025.