Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy |
| |
| Affiliation: | 1. Department of Clinical Sciences Lund, Section of Rheumatology, Lund University, Skåne University Hospital, SE-221 85 Lund, Sweden;2. Department of Infectious Diseases, Central Hospital Kristianstad, J A Hedlunds väg 5, SE-291 85 Kristianstad, Sweden;3. Department of Clinical Sciences Lund, Section of Infectious Diseases, Lund University, Skåne University Hospital, SE-221 85 Lund, Sweden;4. Department of Laboratory Medicine, Section of Microbiology, Immunology and Glycobiology, Lund University, Lund, and Clinical Immunology and Transfusion Medicine, Region Skåne, Sweden;1. Wayne State University School of Medicine, Detroit, MI, United States;2. Central Michigan University College of Medicine, Mt. Pleasant/Saginaw, MI, United States;3. Central Michigan University College of Medicine, Mt. Pleasant, MI, United States;1. Department of Poultry Diseases, Faculty of Veterinary Medicine, Mansoura University, Mansoura, Egypt;2. Department of Pathology, Faculty of Veterinary Medicine, Mansoura University, Mansoura, Egypt;3. Department of Pharmacology, Faculty of Veterinary Medicine, Mansoura University, Mansoura, Egypt;1. Wayne State University School of Medicine, United States;2. Yale School of Medicine, United States;1. Faculty of Health Sciences, Ben-Gurion University of the Negev, POB 151, Beer-Sheva 84101, Israel;2. Pfizer Pharma GmbH, Linkstrasse 10, 10785 Berlin, Germany;3. inVentiv Health Clinical, 504 Carnegie Center, Princeton, NJ 08540, USA;4. Pfizer Inc, 500 Arcola Road, Collegeville, PA 14926, USA;5. Pediatric Infectious Disease Unit, Soroka University Medical Center, POB 151, Beer-Sheva 84101, Israel;6. Pfizer Inc, 401 N. Middletown Road, Pearl River, NY 10965, USA |
| |
| Abstract: | AimTo 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.Methods49 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.ResultsAt 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.ConclusionsPneumococcal 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 |
| |
| Keywords: | Systemic vasculitis Pneumococcal vaccination Pneumococcal conjugate vaccine |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
