RAVaccimilNCT02240888
Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response
A study testing 0,5 mg Prevenar i.m. and 0,5 mg seasonal influenza vaccine i.m. in people with RA and SLE, run by Region Skane at 1 site in Sweden.
Trial summary
The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RA, SLE, Vasculitis
- What is being tested?
- 0,5 mg Prevenar i.m. and 0,5 mg seasonal influenza vaccine i.m.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to 31 May 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage, smoking habits and alcohol consumption.
Who cannot join
- age <18 years;
- pregnancy,
- known intolerance of vaccine,
- ongoing infection
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.
- Conditions
- RA, SLE, Vasculitis, Scleroderma, Sjögrens, Syndrome
- Being tested
- 0,5 mg Prevenar i.m., 0,5 mg seasonal influenza vaccine i.m.
- Keywords
- pneumococcal, vaccination, antibody, response, immunosuppressive, treatment, inflammatory, rheumatic, disease
- Medical subject headings
- Vasculitis, Scleroderma, Diffuse, Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0,5 mg Prevenar i.m.Biological
0,5 mg seasonal influenza vaccine i.m.Biological
| Study group | Role | What they receive |
|---|---|---|
| vaccinated patients | Active comparator | patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m. Receives: Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m. |
| vaccinated controls | Active comparator | healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m. Receives: Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m. |
| seasonal influenza vaccine | Active comparator | patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m. Receives: Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m. |
| non-vaccinated controls | Active comparator | healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m. Receives: Biological: 0,5 mg Prevenar i.m.; Biological: 0,5 mg seasonal influenza vaccine i.m. |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibody response following vaccination
measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains
Measured: 4-6 weeks after pneumococcal and influenza vaccination
Secondary outcomes (2)
long-term immunity following pneumococcal vaccination
measurement of antibody levels against different pneumococcal capsular serotypes
Measured: 3 years after pneumococcal vaccination
long-term immunity after vaccination with pneumococcal conjugate vaccine
measurement of antibody levels against different pneumococcal polysaccharide serotypes
Measured: 5 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startOct 2011
- Primary completion31 Dec 2017
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RAStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, meliha crnkic kapetanovic, Region Skane
- Investigators
- Meliha C Kapetanovic, MD, PhD, Principal investigator, Region SkaneJehns Martineus, MD, Study director, Skåne Universitets sjukhus, dept of rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240888
- Sponsor's protocol ID
- 2011/341
- Other IDs
- Vaccimil
- Acronym
- Vaccimil
- Status last verified
- Oct 2018
- First submitted
- 4 Sep 2014
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Nived P, Saxne T, Geborek P, Mandl T, Skattum L, Kapetanovic MC. Antibody response to 13-valent pneumococcal conjugate vaccine is not impaired in patients with rheumatoid arthritis or primary Sjogren's syndrome without disease modifying treatment. BMC Rheumatol. 2018 Apr 5;2:12. doi: 10.1186/s41927-018-0019-6. eCollection 2018.
PubMed 30886963Hesselstrand R, Nagel J, Saxne T, Geborek P, Skattum L, Kapetanovic MC. Immunogenicity and safety of pneumococcal vaccination in patients with systemic sclerosis. Rheumatology (Oxford). 2018 Apr 1;57(4):625-630. doi: 10.1093/rheumatology/kex471.
PubMed 29325173Nived P, Nagel J, Saxne T, Geborek P, Jonsson G, Skattum L, Kapetanovic MC. Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy. Vaccine. 2017 Jun 22;35(29):3639-3646. doi: 10.1016/j.vaccine.2017.05.044. Epub 2017 May 25.
PubMed 28552512Kapetanovic MC, Nagel J, Nordstrom I, Saxne T, Geborek P, Rudin A. Methotrexate reduces vaccine-specific immunoglobulin levels but not numbers of circulating antibody-producing B cells in rheumatoid arthritis after vaccination with a conjugate pneumococcal vaccine. Vaccine. 2017 Feb 7;35(6):903-908. doi: 10.1016/j.vaccine.2016.12.068. Epub 2017 Jan 9.
PubMed 28081972
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response
- ClinicalTrials.gov ID
- NCT02240888
- Acronym / sponsor ID
- Vaccimil / 2011/341
- Conditions
- RA, SLE, Vasculitis, Scleroderma, Sjögrens, Syndrome
- Keywords
- pneumococcal, vaccination, antibody, response, immunosuppressive, treatment, inflammatory, rheumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 16 Sep 2014 (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.
The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vaccinated patients | Active comparator | Biological: 0,5 mg Prevenar i.m., Biological: 0,5 mg seasonal influenza vaccine i.m.patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m. |
| vaccinated controls | Active comparator | Biological: 0,5 mg Prevenar i.m., Biological: 0,5 mg seasonal influenza vaccine i.m.healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m. |
| seasonal influenza vaccine | Active comparator | Biological: 0,5 mg Prevenar i.m., Biological: 0,5 mg seasonal influenza vaccine i.m.patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m. |
| non-vaccinated controls | Active comparator | Biological: 0,5 mg Prevenar i.m., Biological: 0,5 mg seasonal influenza vaccine i.m.healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage, smoking habits and alcohol consumption.
Key exclusion criteria (4 listed)
- age <18 years;
- pregnancy,
- known intolerance of vaccine,
- ongoing infection
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 |
|---|---|---|
| 0,5 mg Prevenar i.m. | Biological | non-vaccinated controls, seasonal influenza vaccine, vaccinated controls, vaccinated patients |
| 0,5 mg seasonal influenza vaccine i.m. | Biological | non-vaccinated controls, seasonal influenza vaccine, vaccinated controls, vaccinated patients |
Primary outcome
antibody response following vaccination
Time frame: 4-6 weeks after pneumococcal and influenza vaccination
measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains
2 secondary outcomes
long-term immunity following pneumococcal vaccination
Time frame: 3 years after pneumococcal vaccination
long-term immunity after vaccination with pneumococcal conjugate vaccine
Time frame: 5 years after vaccination
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 Oct 2018.
- Derived from this study: PubMed 30886963Nived P, Saxne T, Geborek P, Mandl T, Skattum L, Kapetanovic MC. Antibody response to 13-valent pneumococcal conjugate vaccine is not impaired in patients with rheumatoid arthritis or primary Sjogren's syndrome without disease modifying treatment. BMC Rheumatol. 2018 Apr 5;2:12. doi: 10.1186/s41927-018-0019-6. eCollection 2018.
- Derived from this study: PubMed 29325173Hesselstrand R, Nagel J, Saxne T, Geborek P, Skattum L, Kapetanovic MC. Immunogenicity and safety of pneumococcal vaccination in patients with systemic sclerosis. Rheumatology (Oxford). 2018 Apr 1;57(4):625-630. doi: 10.1093/rheumatology/kex471.
- Derived from this study: PubMed 28552512Nived P, Nagel J, Saxne T, Geborek P, Jonsson G, Skattum L, Kapetanovic MC. Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy. Vaccine. 2017 Jun 22;35(29):3639-3646. doi: 10.1016/j.vaccine.2017.05.044. Epub 2017 May 25.
- Derived from this study: PubMed 28081972Kapetanovic MC, Nagel J, Nordstrom I, Saxne T, Geborek P, Rudin A. Methotrexate reduces vaccine-specific immunoglobulin levels but not numbers of circulating antibody-producing B cells in rheumatoid arthritis after vaccination with a conjugate pneumococcal vaccine. Vaccine. 2017 Feb 7;35(6):903-908. doi: 10.1016/j.vaccine.2016.12.068. Epub 2017 Jan 9.
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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.
Meliha C Kapetanovic, MD, PhD principal investigator
Region Skane
Jehns Martineus, MD study director
Skåne Universitets sjukhus, dept of rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0,5 mg Prevenar i.m. and 0,5 mg seasonal influenza vaccine i.m. in people with RA and SLE, run by Region Skane at 1 site in Sweden.
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 1 inclusion and 4 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 Oct 2018. 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 Sweden. 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?
antibody response following vaccination (time frame: 4-6 weeks after pneumococcal and influenza vaccination). 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 NCT02240888, which also lists 4 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 3 Oct 2018.