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| ID | Type | Description | Link |
|---|---|---|---|
| Vaccimil | Other Identifier | Vaccimil |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccinated patients | Active Comparator | patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m. |
|
| vaccinated controls | Active Comparator | healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m. |
|
| seasonal influenza vaccine | Active Comparator | patients with different inflammatory rheumatic diseases immunized with 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0,5 mg Prevenar i.m. | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| antibody response following vaccination | measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains | 4-6 weeks after pneumococcal and influenza vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| long-term immunity following pneumococcal vaccination | measurement of antibody levels against different pneumococcal capsular serotypes | 3 years after pneumococcal vaccination |
| long-term immunity after vaccination with pneumococcal conjugate vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| The occurence of severe pneumococcal infections in immunized patients | Analysis of the occurence of severe pneumococcal infections in immunized patients compared to matched not-immunized controls | within 5 years after pneumococcal vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meliha C Kapetanovic, MD, PhD | Region Skane | Principal Investigator |
| Jehns Martineus, MD | Skåne Universitets sjukhus, dept of rheumatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University hospital, Dept of rheumatology | Lund | SE-22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30886963 | Derived | 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. | |
| 29325173 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 11, 2018 | |
| Reset | Mar 21, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 11, 2018 | Mar 21, 2019 |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D045743 | Scleroderma, Diffuse |
| D013577 | Syndrome |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
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| 0,5 mg seasonal influenza vaccine i.m. | Biological |
|
measurement of antibody levels against different pneumococcal polysaccharide serotypes
| 5 years after vaccination |
| Hesselstrand 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. |
| 28552512 | Derived | Nived 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. |
| 28081972 | Derived | Kapetanovic 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. |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |