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Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy

Nived, Per LU ; Nagel, Johanna LU ; Saxne, Tore LU ; Geborek, Pierre LU ; Jönsson, Göran LU ; Skattum, Lillemor LU and Kapetanovic, Meliha C. LU (2017) In Vaccine 35(29). p.3639-3646
Abstract

Aim: To study the effect of standard of care therapy on antibody response and functionality following immunization with 13-valent pneumococcal conjugate vaccine (PCV13) in patients with primary systemic vasculitis compared to healthy controls. Methods: 49 patients with vasculitis and 49 controls received a single dose (0.5. ml) PCV13 intramuscularly. Ongoing treatments: azathioprine (AZA; n = 11), cyclophosphamide (CYC; n = 6), methotrexate (MTX; n = 9), rituximab (n = 3); anti-TNF (n = 2), mycophenolate mofetil (n = 2), prednisolone alone (n = 15) and no active treatment (n = 2). Specific antibody concentrations for serotypes 6B and 23F were determined using ELISA and opsonophagocytic activity (OPA) assay (23F) was performed, on serum... (More)

Aim: To study the effect of standard of care therapy on antibody response and functionality following immunization with 13-valent pneumococcal conjugate vaccine (PCV13) in patients with primary systemic vasculitis compared to healthy controls. Methods: 49 patients with vasculitis and 49 controls received a single dose (0.5. ml) PCV13 intramuscularly. Ongoing treatments: azathioprine (AZA; n = 11), cyclophosphamide (CYC; n = 6), methotrexate (MTX; n = 9), rituximab (n = 3); anti-TNF (n = 2), mycophenolate mofetil (n = 2), prednisolone alone (n = 15) and no active treatment (n = 2). Specific antibody concentrations for serotypes 6B and 23F were determined using ELISA and opsonophagocytic activity (OPA) assay (23F) was performed, on serum samples taken immediately before and 4-6. weeks after vaccination. Proportion of individuals with putative protective antibody concentration (≥1.0. μg/mL) and positive antibody response (≥2-fold increase from prevaccination concentration) for both serotypes were calculated and groups were compared. Results: At baseline, 6 patients (12%) and 12 controls (24%) had protective antibody levels for both serotypes. After vaccination, antibodies increased for both serotypes in patients and controls (p <. 0.001), 32 patients (65%) and 35 controls (71%) reached protective level for 6B, and 32 patients (65%) and 37 controls (76%) for 23. F. Compared to controls, patients had lower prevaccination geometric mean concentration (23F, p = 0.01) and a numerical trend towards lower prevaccination level (6B) and postvaccination levels (both serotypes). Patients with prednisolone alone had lower prevaccination OPA (p <. 0.01) compared to controls. OPA increased after vaccination in both patients and controls (p <. 0.001), but improvement was better in controls (p = 0.001). AZA, CYC or MTX, but not prednisolone alone, tended towards a lower proportion of patients reaching protective antibody levels (p = 0.06), compared to controls. Conclusions: Pneumococcal conjugate vaccine was safe and immunogenic in patients with established vasculitis. Treatment with DMARDs, mostly AZA, CYC and MTX but not systemic prednisolone may impair antibody response. Trial registration. ClinicalTrials.gov Identifier: NCT02240888. Registered 4 September, 2014.

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author
organization
publishing date
type
Contribution to journal
publication status
published
keywords
Pneumococcal conjugate vaccine, Pneumococcal vaccination, Systemic vasculitis
in
Vaccine
volume
35
issue
29
pages
3639 - 3646
publisher
Elsevier
external identifiers
  • scopus:85019906869
  • wos:000404323200003
ISSN
0264-410X
DOI
10.1016/j.vaccine.2017.05.044
language
English
LU publication?
yes
id
81e990bf-2fe5-46d3-8540-02d08c085065
date added to LUP
2017-06-16 12:13:57
date last changed
2018-04-15 04:44:34
@article{81e990bf-2fe5-46d3-8540-02d08c085065,
  abstract     = {<p>Aim: To study the effect of standard of care therapy on antibody response and functionality following immunization with 13-valent pneumococcal conjugate vaccine (PCV13) in patients with primary systemic vasculitis compared to healthy controls. Methods: 49 patients with vasculitis and 49 controls received a single dose (0.5. ml) PCV13 intramuscularly. Ongoing treatments: azathioprine (AZA; n = 11), cyclophosphamide (CYC; n = 6), methotrexate (MTX; n = 9), rituximab (n = 3); anti-TNF (n = 2), mycophenolate mofetil (n = 2), prednisolone alone (n = 15) and no active treatment (n = 2). Specific antibody concentrations for serotypes 6B and 23F were determined using ELISA and opsonophagocytic activity (OPA) assay (23F) was performed, on serum samples taken immediately before and 4-6. weeks after vaccination. Proportion of individuals with putative protective antibody concentration (≥1.0. μg/mL) and positive antibody response (≥2-fold increase from prevaccination concentration) for both serotypes were calculated and groups were compared. Results: At baseline, 6 patients (12%) and 12 controls (24%) had protective antibody levels for both serotypes. After vaccination, antibodies increased for both serotypes in patients and controls (p &lt;. 0.001), 32 patients (65%) and 35 controls (71%) reached protective level for 6B, and 32 patients (65%) and 37 controls (76%) for 23. F. Compared to controls, patients had lower prevaccination geometric mean concentration (23F, p = 0.01) and a numerical trend towards lower prevaccination level (6B) and postvaccination levels (both serotypes). Patients with prednisolone alone had lower prevaccination OPA (p &lt;. 0.01) compared to controls. OPA increased after vaccination in both patients and controls (p &lt;. 0.001), but improvement was better in controls (p = 0.001). AZA, CYC or MTX, but not prednisolone alone, tended towards a lower proportion of patients reaching protective antibody levels (p = 0.06), compared to controls. Conclusions: Pneumococcal conjugate vaccine was safe and immunogenic in patients with established vasculitis. Treatment with DMARDs, mostly AZA, CYC and MTX but not systemic prednisolone may impair antibody response. Trial registration. ClinicalTrials.gov Identifier: NCT02240888. Registered 4 September, 2014.</p>},
  author       = {Nived, Per and Nagel, Johanna and Saxne, Tore and Geborek, Pierre and Jönsson, Göran and Skattum, Lillemor and Kapetanovic, Meliha C.},
  issn         = {0264-410X},
  keyword      = {Pneumococcal conjugate vaccine,Pneumococcal vaccination,Systemic vasculitis},
  language     = {eng},
  month        = {06},
  number       = {29},
  pages        = {3639--3646},
  publisher    = {Elsevier},
  series       = {Vaccine},
  title        = {Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy},
  url          = {http://dx.doi.org/10.1016/j.vaccine.2017.05.044},
  volume       = {35},
  year         = {2017},
}