Safety and Immunogenicity of Pneumococcal Vaccine in Patients with Systemic Sclerosis and Healthy Controls

Johanna Nagel¹, Tore Saxne², Pierre Geborek³, Lillemor Scattum⁴, Roger Hesselstrand⁵ and Meliha C. Kapetanovic³, ¹Department of Clinical Sciences, Lund, Section of Rheumatology, Lund University and Skåne University Hospital, Lund, Sweden, Lund, Sweden, ²Dept of Clinical Sciences, Lund, Section of Rheumatology, Lund University, Lund, Sweden, ³Department of Clinical Sciences Lund, Section of Rheumatology Lund University and Skåne University Hospital, Lund, Sweden, ⁴Department of Laboratory Medicine, Section of Microbiology, Immunology and Glycobiology, Lund University, Lund, Sweden, ⁵Department of Clinical Sciences, Section of Rheumatology, Lund University, Lund, Sweden

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Systemic sclerosis and vaccines

Session Information

Date: Sunday, November 8, 2015

Title: Systemic Sclerosis, Fibrosing Syndromes and Raynaud's - Clinical Aspects and Therapeutics Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Studies investigating the immunogenicity of pneumococcal vaccine in patients with systemic sclerosis (SSc) are scarce. We aim to investigate the impact of SSs disease and treatment with disease modifying antirheumatic drugs (DMARDs) on antibody response elicited by either 13-valent pneumococcal conjugate vaccine (PCV13) or 23-valent pneumococcal polysaccharide vaccine (PPV23) in patients with SSc compared to healthy controls (HC).

Methods: In total, 44 SSc patients receiving standard of care treatment and 49 HC were vaccinated with a single dose of either PCV13 or PPV23. of 44, 12 SSc patients received DMARDs (mycophenolate mofetil=7; azathioprine=4 and azathioprine+hydroxychloroquine=1). Response to two pneumococcal capsular polysaccharides (6B and 23F) were measured in serum before and 4-6 weeks after vaccination using standard ELISA. Geometric mean levels (GML) were calculated from log transformed pre- and postvaccination antibody levels and then compared using paired T-test. Antibody responses between vaccines were also compared.

Results: Both vaccines were generally well tolerated. Number of patients, percentage female (%), mean age and mean disease duration (years) at vaccination were: 32, 94%, 57.5 and 11.4 years in SSs without DMARDs; 12, 100%, 55.5 and 6.2 years in SSc patients on DMARDs and 49, 63% and 50.6 years in HC. Numbers of patients immunized with PCV13 or PPV23 and GML (95% CI) for both serotypes tested are shown in Table. Prevaccination antibody levels to both serotypes did not differ between three groups (Mann-Whitney U-test). Prevaccination antibody levels for both serotypes increased significantly in SSc without DMARDs and HC (p<0.001) but not in SSc patients on DMARDs (p=0.115 for 6B and p= 0.091 for 23F). Compared to HC and SSc without DMARDs patients with SSc treated with DMARDs had lower postvaccination antibody levels for both serotypes. There were no significant differences in antibody levels between SSc patients without DMARDs and HC. When pre- and postvaccination antibody levels for 6B and 23F were compered between individuals immunised with PCV13 and those immunised with PPV23, no significant difference was seen within the same treatment group or within the whole study population.

Conclusion: Pneumococcal vaccination using either PCV13 or PPV23 yielded satisfactory antibody response in SSc patients not treated with DMARDs but decreased levels in patients treated with synthetic DMARDs suggesting a need of vaccination before start of treatment. Type of pneumococcal vaccine (conjugate vs polysaccharide) did not have a significant impact on the vaccination response.

ClinicalTrials.gov Identifier: NCT02240888

Table. Numbers of patients immunized with PCV13 or PPV23 and GML (95% CI) for serotypes 6B and 23F

13-valent PCV

antibody levels

GML (95% CI)

23-valent PPV

antibody levels

GML (95% CI)

Treatment groups (number of patients)

Serotypes

before vaccination

after vaccination

before vaccination

after vaccination

SSc without DMARDs

(n=32)*

23F

0.7 (0.3-1.6)

0.5 (0.3-0.9)

2.8 (1.6-4.9)

1.4 (0.7-2.8)

0.4 (0.1-1.4)

0.4 (0.1-2.5)

3.1(0.7-14)

7.3 (2.7-20)

SSC on DMARD

(n=12)**

23F

0.3 (0-3.4)

0.3 (0.1-0.7)

1.5 (0.4-5.8)

0.8 (0.2-3.5)

0.5 (0.1-4.0)

0.5 (0-9.3)

0.6 (0-15)

0.6 (0-18)

Healthy controls

(n=49)***

23F

0.9 (0.5-1.6)

0.6 (0.4-1.0)

2.8 (1.7-4.8)

3.4 (2.0-5.7)

0.3 (0.1-0.7)

0.5 (0.1-3.3)

5.9 (0.9-40)

3.1 (0.2-45)

*25 patients received PCV13 and 7 patients received PPV23; **SSC 6 patients received PCV13 and 6 patients received PPV23; *** 44 patients received PCV13 and 5 patients received PPV23

Disclosure: J. Nagel, None; T. Saxne, None; P. Geborek, None; L. Scattum, None; R. Hesselstrand, None; M. C. Kapetanovic, None.

To cite this abstract in AMA style:

Nagel J, Saxne T, Geborek P, Scattum L, Hesselstrand R, Kapetanovic MC. Safety and Immunogenicity of Pneumococcal Vaccine in Patients with Systemic Sclerosis and Healthy Controls [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/safety-and-immunogenicity-of-pneumococcal-vaccine-in-patients-with-systemic-sclerosis-and-healthy-controls/. Accessed .

« Back to 2015 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-immunogenicity-of-pneumococcal-vaccine-in-patients-with-systemic-sclerosis-and-healthy-controls/