Chronic Obstructive Pulmonary DiseaseALTIBPCONCT03804138
Immune Damage and Vaccination in COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial summary
Better understanding of the specificities of the vaccine response in patients with COPD Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Anti-influenza and DTp pertussis vaccinations
- Type of treatment
- Vaccines
- How many people
- 37 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Oct 2018to 3 Feb 2023
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be offered to patients for whom there is a prescription for influenza vaccination and DTp, COPD or non-COPD
Who may be able to join
- Acceptance to participate in the protocol
- Affiliated to a social security scheme
- Age between 40 and 65 years COPD patients
- Diagnosis of moderate to very severe COPD with FEV1 / FVC <0.7 and FEV1 <80% of predicted value, cumulative smoking greater than 10PA
- Indication reminder dTP pertussis when the last booster <5 years Patients without COPD
- FEV / FVC> 0.8
- Indication reminder dTP pertussis when the last booster <5 years
- Indication and patient's wish for an influenza vaccination
Who cannot join
- Refusal to participate in the study
- Progressive cancer and / or treated in the last 5 years, uncontrolled heart failure, connective tissue disease, inflammatory disease of the digestive tract during treatment.
- Exacerbation or any upper or lower respiratory infection in the previous month.
- Any cause of immunodepression, including long-term oral corticosteroids.
- Pregnant or lactating woman
Trial locations and contacts
2 sites in 1 country.
About this study
Better understanding of the specificities of the vaccine response in patients with COPD
Read the detailed description
Chronic obstructive pulmonary disease (COPD) will become the third leading cause of death worldwide in 2020 (3.5 million patients, 16500 deaths in France). Its socio-economic cost is related to the handicap induced by the decline of the respiratory function, as well as to the occurrence of exacerbations, main causes of hospitalization and mortality. Since exacerbations are mostly infectious, a preventive strategy involves routine influenza vaccination. Although it is highly recommended in this population, there is no formal evidence of its effectiveness during COPD. While correlates of influenza vaccine efficacy exist, cellular and humoral responses to this vaccine have been poorly evaluated in these patients. This alteration of the vaccine response could also be integrated into an overall deficit of the response to a vaccine in these patients.
As influenza virus infection is one of the most important causes of death in patients with COPD, and vaccination is the best way to prevent it, it is essential to better understand the immune response in the context of vaccination in this population. The investigator's hypothesis is that there would be a global alteration of the immunological immune response in the COPD patient involving abnormalities of lymphocyte B differentiation and the effector capacity of T lymphocytes, notably through the activation of the PD1 / PDL1 axis.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Anti-influenza and DTp pertussis vaccinations
- 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.
Anti-influenza and DTp pertussis vaccinationsOther
Anti-influenza and DTp pertussis vaccinations will be performed during the visit by the clinical research nurse. The vaccine has been prescribed as part of the care either by the patient's physician (pulmonologist or general practitioner).
| Study group | Role | What they receive |
|---|---|---|
| Patient | patient with COPD Receives: Other: Anti-influenza and DTp pertussis vaccinations | |
| control group | patient without COPD Receives: Other: Anti-influenza and DTp pertussis vaccinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and evolution of specific antibodies and Cellular B vaccine response
Rate and evolution of J30-specific antibodies according to WHO criteria Tetanus: before vaccination a rate> 0.1 IU / ml is considered protective, that is usually at a rate> 1 IU / ml after booster vaccination Influenza: antibody concentrations exceeding 0.15 μg / ml are considered protective Pertussis: anti-pertussis toxin IgG (PT) Cellular B vaccine response (plasmablast on D7)
Measured: 30 days
Secondary outcomes (4)
Type of Cellular T cell response
Cellular T cell response (Tfh, Treg, TCD4 / TCD8 specific)
Measured: 15 days
Transcriptomic analysis
Transcriptomic analysis in the pre- and post-vaccination period (vaccine signature) and comparison with matched subjects
Measured: 30 days
Number of Lymphocyte populations
Analysis of lymphocyte populations B and T
Measured: 7 days
Number of exacerbations
Number of minimal, moderate and severe exacerbations within 6 months of vaccination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start9 Oct 2018
- Primary completion3 Feb 2021
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Boyer, MD, Principal investigator, CHU Henri-Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804138
- Sponsor's protocol ID
- ALTIBPCO
- Other IDs
- 2018-A01719-46
- Acronym
- ALTIBPCO
- Status last verified
- Apr 2023
- First submitted
- 11 Jan 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Damage and Vaccination in COPD Patients
- ClinicalTrials.gov ID
- NCT03804138
- Acronym / sponsor ID
- ALTIBPCO / ALTIBPCO
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 15 Jan 2019 (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.
Better understanding of the specificities of the vaccine response in patients with COPD
Detailed description
Chronic obstructive pulmonary disease (COPD) will become the third leading cause of death worldwide in 2020 (3.5 million patients, 16500 deaths in France). Its socio-economic cost is related to the handicap induced by the decline of the respiratory function, as well as to the occurrence of exacerbations, main causes of hospitalization and mortality. Since exacerbations are mostly infectious, a preventive strategy involves routine influenza vaccination. Although it is highly recommended in this population, there is no formal evidence of its effectiveness during COPD. While correlates of influenza vaccine efficacy exist, cellular and humoral responses to this vaccine have been poorly evaluated in these patients. This alteration of the vaccine response could also be integrated into an overall deficit of the response to a vaccine in these patients.
As influenza virus infection is one of the most important causes of death in patients with COPD, and vaccination is the best way to prevent it, it is essential to better understand the immune response in the context of vaccination in this population. The investigator's hypothesis is that there would be a global alteration of the immunological immune response in the COPD patient involving abnormalities of lymphocyte B differentiation and the effector capacity of T lymphocytes, notably through the activation of the PD1 / PDL1 axis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Anti-influenza and DTp pertussis vaccinationspatient with COPD |
| control group | – | Other: Anti-influenza and DTp pertussis vaccinationspatient without COPD |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be offered to patients for whom there is a prescription for influenza vaccination and DTp, COPD or non-COPD
Key inclusion criteria (8 listed)
- Acceptance to participate in the protocol
- Affiliated to a social security scheme
- Age between 40 and 65 years COPD patients
- Diagnosis of moderate to very severe COPD with FEV1 / FVC <0.7 and FEV1 <80% of predicted value, cumulative smoking greater than 10PA
- Indication reminder dTP pertussis when the last booster <5 years Patients without COPD
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Progressive cancer and / or treated in the last 5 years, uncontrolled heart failure, connective tissue disease, inflammatory disease of the digestive tract during treatment.
- Exacerbation or any upper or lower respiratory infection in the previous month.
- Any cause of immunodepression, including long-term oral corticosteroids.
- Pregnant or lactating woman
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 |
|---|---|---|
| Anti-influenza and DTp pertussis vaccinationsAnti-influenza and DTp pertussis vaccinations will be performed during the visit by the clinical research nurse. The vaccine has been prescribed as part of the care either by the patient's physician (pulmonologist or general practitioner). | Other | Patient, control group |
Primary outcome
Rate and evolution of specific antibodies and Cellular B vaccine response
Time frame: 30 days
Rate and evolution of J30-specific antibodies according to WHO criteria Tetanus: before vaccination a rate> 0.1 IU / ml is considered protective, that is usually at a rate> 1 IU / ml after booster vaccination Influenza: antibody concentrations exceeding 0.15 μg / ml are considered protective Pertussis: anti-pertussis toxin IgG (PT) Cellular B vaccine response (plasmablast on D7)
4 secondary outcomes
Type of Cellular T cell response
Time frame: 15 days
Transcriptomic analysis
Time frame: 30 days
Number of Lymphocyte populations
Time frame: 7 days
Number of exacerbations
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
Laurent Boyer, MD principal investigator
CHU Henri-Mondor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
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 8 inclusion and 5 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 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate and evolution of specific antibodies and Cellular B vaccine response (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2023.