Rheumatoid ArthritisVACINANCT02547493
Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients
A study testing pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine and Abatacept in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 11 sites in 2 countries.
Trial summary
Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral response) in RA patients treated with abatacept, biotherapy targeting T-cells? The investigator propose to conduct a prospective, multicenter… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine and Abatacept
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 3 Mar 2016to 18 Jan 2021
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA according to American College of Rheumatology (ACR)/European League Against rheumatism (EULAR) 2010 criteria
- Disease Activity Score (DAS) 28 ≥ 3.2
- Initiation of a treatment by sub-cutaneous abatacept in combination with methotrexate (MTX), whatever treatment they were receiving before (apart from rituximab (RTX) in the last year)
- Patient has signed study consent form
Who cannot join
- age < 18 or > 85 year
- dementia
- patients subjects to legal protection measures
- Corticosteroids ≥ 10mg/d the day of inclusion
- Patient who had a pneumococcal vaccination in the previous 3 years
- Last pneumococcal vaccination < 3 year
Show all 22Show fewer
- rituximab in the last year
- History of anaphylactic response to a vaccination
- Contraindications to abatacept or methotrexate
- Pregnancy or pregnancy wish
- Breast feeding
- Patient who currently abuse drugs or alcohol
- Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication.
- Subject who have receive any vaccine within 1 month of the anticipated first dose of the study medication and for all the duration of the study
- Patient with contraindication to intramuscular injections
- Subject with respiratory insufficiency
- Subject at risk for Tuberculosis.
- Blood transfusion within the 3 months previous to the study and for all the duration of the study.
- Concomitant biologic disease-modifying antirheumatic drug (DMARD)
- Within 4 weeks of receiving treatment with any investigational drug.
- Patient positive for hepatitis B surface antigen
- Patient who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
France10 sites
CHU Nord
Amiens, 80054
CHU Pellegrin
Bordeaux, 33076
CHU Montpied
Clermont-Ferrand, 63000
CHU Bicêtre
Le Kremlin-Bicêtre, 94275
CHRU Roger Salengro
Lille, 59037
CHRU de Montpellier
Montpellier, Hérault, 34295
CHU Carémeau
Nîmes, 30029
CHU Orléans
Orléans, 45000
CHU La pitié salpétriere
Paris, 78013
CHU Hautepierre
Strasbourg, 67200
About this study
Official title: Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept
Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral response) in RA patients treated with abatacept, biotherapy targeting T-cells? The investigator propose to conduct a prospective, multicenter (11 centers), randomized, open-label study.
The patients are going to be randomized in 2 groups: patients of the first group will be vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas patients of the second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).
Read the detailed description
The study population will be all the RA patients between 18 and 85 years with instauration of a treatment by sub-cutaneous abatacept in association with methotrexate who agreed to participate to the study.
At the time of their inclusion, patients will be randomized for receiving either pneumococcal polysaccharide vaccine (PPSV) or pneumococcal conjugate vaccine (PCV).
The primary endpoint will be evaluated at one month after vaccination. The total of follow-up will be of 12 months.
For the patients of the group PCV, the prime-boost strategy will be applied in order to be in accordance with the current French recommendation and a revaccination at 2 months after the initial vaccine will be realized with PPSV.
- Conditions
- Rheumatoid Arthritis
- Being tested
- pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, Abatacept
- Keywords
- Vaccination against Pneumococcal, Naïve Abatacept patients
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumococcal polysaccharide vaccineBiological
Also called Pneumo23/Pneumovax
Vaccination with PPSV on first day. NB : PPSV vaccine Pneumo23 has been replaced in September 2017 by the equivalent vaccine Pneumovax because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company.
pneumococcal conjugate vaccineBiological
Also called Prevenar13
Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.
AbataceptDrug
Also called Orencia
Abatacept started on frst day
| Study group | Role | What they receive |
|---|---|---|
| pneumococcal polysaccharide vaccine | Active comparator | Patients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day. Receives: Biological: pneumococcal polysaccharide vaccine; Drug: Abatacept |
| pneumococcal conjugate vaccine | Active comparator | Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.
Abatacept started on frst day. Receives: Biological: pneumococcal conjugate vaccine; Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral response comparison after vaccination (number of patient with at least a two-fold increase of the antibody titer for at least 3 of the 5 serotypes of interest : 1,3 14, 7F, 19A)
To compare the rate of responders, at one month after vaccination, between patients vaccinated with PCV and patient vaccinated with PPSV.
Measured: 1 month after vaccination
Secondary outcomes (5)
Side Effect frequency (number of side effect at each patient's visit for both groups)
Comparison of the frequency of side effects between the 2 groups at 1, 2, 6 and 12 months
Measured: 1, 2,6 ans 12 months after inclusion
Prime boost strategy efficacity evaluation (number of responder in the PCV group)
Calculation of the rate of responders, in the PCV group, at 4 month after re-vaccination by a dose of PPSV
Measured: 6 months after inclusion
Long term immune response after vaccination
Comparison between the 2 groups of the rate of responders at 6 and 12 months after vaccination
Measured: 6 and 12 months after vaccination
Comparison between the 2 groups of the opsonophagocytosis activity of the antibodies produced
Comparison between the 2 groups of the opsonophagocytic titers (OPA) at 1, 2, 6 and 12 months after vaccination
Measured: 1, 2, 6 and 12 months after vaccination
Pneumococcal vaccination predictive factor identification
Analysis of the collected date to search for predictive factors of immune response after pneumococcal vaccination by comparison of the rates of responders within each group, according to age, gender, RA activity, MTX dosage, corticosteroid, dosage, therapeutical history
Measured: 12 month after last patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start3 Mar 2016
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Jacques Morel, MD PhD, Principal investigator, CHRU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547493
- Sponsor's protocol ID
- 9419
- Acronym
- VACINA
- Status last verified
- Dec 2021
- First submitted
- 7 Sep 2015
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept
- ClinicalTrials.gov ID
- NCT02547493
- Acronym / sponsor ID
- VACINA / 9419
- Conditions
- Rheumatoid Arthritis
- Keywords
- Vaccination against Pneumococcal, Naïve Abatacept patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 11 Sep 2015 (estimated)
- 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.
Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral response) in RA patients treated with abatacept, biotherapy targeting T-cells? The investigator propose to conduct a prospective, multicenter (11 centers), randomized, open-label study.
The patients are going to be randomized in 2 groups: patients of the first group will be vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas patients of the second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).
Detailed description
The study population will be all the RA patients between 18 and 85 years with instauration of a treatment by sub-cutaneous abatacept in association with methotrexate who agreed to participate to the study.
At the time of their inclusion, patients will be randomized for receiving either pneumococcal polysaccharide vaccine (PPSV) or pneumococcal conjugate vaccine (PCV).
The primary endpoint will be evaluated at one month after vaccination. The total of follow-up will be of 12 months.
For the patients of the group PCV, the prime-boost strategy will be applied in order to be in accordance with the current French recommendation and a revaccination at 2 months after the initial vaccine will be realized with PPSV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pneumococcal polysaccharide vaccine | Active comparator | Biological: pneumococcal polysaccharide vaccine, Drug: AbataceptPatients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day. |
| pneumococcal conjugate vaccine | Active comparator | Biological: pneumococcal conjugate vaccine, Drug: AbataceptPatients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later. Abatacept started on frst day. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- RA according to American College of Rheumatology (ACR)/European League Against rheumatism (EULAR) 2010 criteria
- Disease Activity Score (DAS) 28 ≥ 3.2
- Initiation of a treatment by sub-cutaneous abatacept in combination with methotrexate (MTX), whatever treatment they were receiving before (apart from rituximab (RTX) in the last year)
- Patient has signed study consent form
Key exclusion criteria (22 listed)
- age < 18 or > 85 year
- dementia
- patients subjects to legal protection measures
- Corticosteroids ≥ 10mg/d the day of inclusion
- Patient who had a pneumococcal vaccination in the previous 3 years
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 |
|---|---|---|
| pneumococcal polysaccharide vaccineAlso: Pneumo23/PneumovaxVaccination with PPSV on first day. NB : PPSV vaccine Pneumo23 has been replaced in September 2017 by the equivalent vaccine Pneumovax because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company. | Biological | pneumococcal polysaccharide vaccine |
| pneumococcal conjugate vaccineAlso: Prevenar13Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later. | Biological | pneumococcal conjugate vaccine |
| AbataceptAlso: OrenciaAbatacept started on frst day | Drug | pneumococcal conjugate vaccine, pneumococcal polysaccharide vaccine |
Primary outcome
Humoral response comparison after vaccination (number of patient with at least a two-fold increase of the antibody titer for at least 3 of the 5 serotypes of interest : 1,3 14, 7F, 19A)
Time frame: 1 month after vaccination
To compare the rate of responders, at one month after vaccination, between patients vaccinated with PCV and patient vaccinated with PPSV.
5 secondary outcomes
Side Effect frequency (number of side effect at each patient's visit for both groups)
Time frame: 1, 2,6 ans 12 months after inclusion
Prime boost strategy efficacity evaluation (number of responder in the PCV group)
Time frame: 6 months after inclusion
Long term immune response after vaccination
Time frame: 6 and 12 months after vaccination
Comparison between the 2 groups of the opsonophagocytosis activity of the antibodies produced
Time frame: 1, 2, 6 and 12 months after vaccination
Pneumococcal vaccination predictive factor identification
Time frame: 12 month after last patient inclusion
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 3 Jan 2022.
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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.
Jacques Morel, MD PhD principal investigator
CHRU de Montpellier
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine and Abatacept in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 11 sites in 2 countries.
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 22 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Monaco. 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?
Humoral response comparison after vaccination (number of patient with at least a two-fold increase of the antibody titer for at least 3 of the 5 serotypes of interest : 1,3 14, 7F, 19A) (time frame: 1 month after vaccination). 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 3 Jan 2022.