ASSESSMENT OF THE IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATIC DISEASES
Objective: to investigate the immunogenicity and safety of 23-valent polysaccharide pneumococcal vaccine in patients with rheumatic diseases (RD).Subjects and methods. The prospective open-label comparative study enrolled 133 people (102 (76.7%) women and 31 (23.3%) men) aged 23 to 76 years, includi...
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| Format: | Article |
| Language: | Russian |
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IMA PRESS LLC
2016-02-01
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| Series: | Научно-практическая ревматология |
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| Online Access: | https://rsp.mediar-press.net/rsp/article/view/2147 |
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| author | M. S. Naumtseva B. S. Belov E. N. Aleksandrova G. M. Tarasova A. A. Novikov D. E. Karateev E. L. Luchikhina A. V. Volkov N. N. Yudkina O. A. Antelava A. N. Khelkovskaya-Sergeeva M. V. Cherkasova Yu. V. Muravyev |
| author_facet | M. S. Naumtseva B. S. Belov E. N. Aleksandrova G. M. Tarasova A. A. Novikov D. E. Karateev E. L. Luchikhina A. V. Volkov N. N. Yudkina O. A. Antelava A. N. Khelkovskaya-Sergeeva M. V. Cherkasova Yu. V. Muravyev |
| author_sort | M. S. Naumtseva |
| collection | DOAJ |
| description | Objective: to investigate the immunogenicity and safety of 23-valent polysaccharide pneumococcal vaccine in patients with rheumatic diseases (RD).Subjects and methods. The prospective open-label comparative study enrolled 133 people (102 (76.7%) women and 31 (23.3%) men) aged 23 to 76 years, including 79 patients with rheumatoid arthritis (RA), 16 with systemic sclerosis, and 7 with dermatomyositis/polymyositis, as well as 31 subjects without systemic inflammatory RD (a control group), who had a recent history of at least two cases of lower respiratory tract infections (bronchitis, pneumonia). At their inclusion, all the patients with RD were receiving ant-inflammatory therapy, including 52 taking methotrexate (MT), 14 – leflunomide (LEF), and 13 – MT + tumor necrosis factor-α (TNF-α) inhibitors. The 23-valent polysaccharide pneumococcal vaccine Pneumo-23 (Sanofi Pasteur, France) was administered in a single dose of 0.5 ml subcutaneously during continuous MT or LEF therapy for the underlying disease or 3–4 weeks before the use of TNF-α inhibitors. Clinical examinations of the patients and conventional laboratory studies were performed during control visits (1, 3, and 12 months after vaccination). The serum levels of anti-pneumococcal capsular polysaccharide antibodies were measured in 102 patients by enzyme immunoassay using commercial VaccZymeTM Anti-PCP IgG Enzyme Immunoassay kits (The Binding Site Group Ltd, United Kingdom).Results and discussion. No clinical and radiological symptoms of pneumonia were recorded in any case during the follow-up period of 12 months. The patients with RD and the control group showed a significant, more than double increase in anti-pneumococcal antibodies 12 months following vaccination. Vaccination was well tolerated: 90 (68%) patients displayed no adverse events; 37 (28%) had pain, cutaneous swelling and hyperemia up to 2 cm in diameter at the site of injection for vaccination;6 (4%) had low-grade fever. There were no episodes of a RD exacerbation or any new autoimmune disorders during the follow-up period.Conclusion. The findings were suggestive of the sufficient immunogenicity and good tolerability of 23-valent pneumococcal vaccine in patients with RD. |
| first_indexed | 2024-04-09T22:25:26Z |
| format | Article |
| id | doaj.art-a70c589eac0e4101914a58f3dc6d1cc2 |
| institution | Directory Open Access Journal |
| issn | 1995-4484 1995-4492 |
| language | Russian |
| last_indexed | 2024-04-09T22:25:26Z |
| publishDate | 2016-02-01 |
| publisher | IMA PRESS LLC |
| record_format | Article |
| series | Научно-практическая ревматология |
| spelling | doaj.art-a70c589eac0e4101914a58f3dc6d1cc22023-03-22T13:45:50ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922016-02-0153658659010.14412/1995-4484-2015-586-5902027ASSESSMENT OF THE IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATIC DISEASESM. S. Naumtseva0B. S. Belov1E. N. Aleksandrova2G. M. Tarasova3A. A. Novikov4D. E. Karateev5E. L. Luchikhina6A. V. Volkov7N. N. Yudkina8O. A. Antelava9A. N. Khelkovskaya-Sergeeva10M. V. Cherkasova11Yu. V. Muravyev12V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; 34A, Kashirskoe Shosse, Moscow 115522Objective: to investigate the immunogenicity and safety of 23-valent polysaccharide pneumococcal vaccine in patients with rheumatic diseases (RD).Subjects and methods. The prospective open-label comparative study enrolled 133 people (102 (76.7%) women and 31 (23.3%) men) aged 23 to 76 years, including 79 patients with rheumatoid arthritis (RA), 16 with systemic sclerosis, and 7 with dermatomyositis/polymyositis, as well as 31 subjects without systemic inflammatory RD (a control group), who had a recent history of at least two cases of lower respiratory tract infections (bronchitis, pneumonia). At their inclusion, all the patients with RD were receiving ant-inflammatory therapy, including 52 taking methotrexate (MT), 14 – leflunomide (LEF), and 13 – MT + tumor necrosis factor-α (TNF-α) inhibitors. The 23-valent polysaccharide pneumococcal vaccine Pneumo-23 (Sanofi Pasteur, France) was administered in a single dose of 0.5 ml subcutaneously during continuous MT or LEF therapy for the underlying disease or 3–4 weeks before the use of TNF-α inhibitors. Clinical examinations of the patients and conventional laboratory studies were performed during control visits (1, 3, and 12 months after vaccination). The serum levels of anti-pneumococcal capsular polysaccharide antibodies were measured in 102 patients by enzyme immunoassay using commercial VaccZymeTM Anti-PCP IgG Enzyme Immunoassay kits (The Binding Site Group Ltd, United Kingdom).Results and discussion. No clinical and radiological symptoms of pneumonia were recorded in any case during the follow-up period of 12 months. The patients with RD and the control group showed a significant, more than double increase in anti-pneumococcal antibodies 12 months following vaccination. Vaccination was well tolerated: 90 (68%) patients displayed no adverse events; 37 (28%) had pain, cutaneous swelling and hyperemia up to 2 cm in diameter at the site of injection for vaccination;6 (4%) had low-grade fever. There were no episodes of a RD exacerbation or any new autoimmune disorders during the follow-up period.Conclusion. The findings were suggestive of the sufficient immunogenicity and good tolerability of 23-valent pneumococcal vaccine in patients with RD.https://rsp.mediar-press.net/rsp/article/view/2147rheumatoid arthritisautoimmune diseasespneumoniabronchitispneumococcal vaccinevaccinationcoinfectionscomorbidityimmunogenicityefficacytolerability |
| spellingShingle | M. S. Naumtseva B. S. Belov E. N. Aleksandrova G. M. Tarasova A. A. Novikov D. E. Karateev E. L. Luchikhina A. V. Volkov N. N. Yudkina O. A. Antelava A. N. Khelkovskaya-Sergeeva M. V. Cherkasova Yu. V. Muravyev ASSESSMENT OF THE IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATIC DISEASES Научно-практическая ревматология rheumatoid arthritis autoimmune diseases pneumonia bronchitis pneumococcal vaccine vaccination coinfections comorbidity immunogenicity efficacy tolerability |
| title | ASSESSMENT OF THE IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATIC DISEASES |
| title_full | ASSESSMENT OF THE IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATIC DISEASES |
| title_fullStr | ASSESSMENT OF THE IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATIC DISEASES |
| title_full_unstemmed | ASSESSMENT OF THE IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATIC DISEASES |
| title_short | ASSESSMENT OF THE IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATIC DISEASES |
| title_sort | assessment of the immunogenicity and safety of 23 valent polysaccharide pneumococcal vaccine in patients with rheumatic diseases |
| topic | rheumatoid arthritis autoimmune diseases pneumonia bronchitis pneumococcal vaccine vaccination coinfections comorbidity immunogenicity efficacy tolerability |
| url | https://rsp.mediar-press.net/rsp/article/view/2147 |
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