Immunogenicity And Safety Of The 13-Valent Pneumococcal Conjugate Vaccine In Patients With Monoclonal Gammopathy Of Undetermined Significance – Relationship With Selected Immune And Clinical Parameters

References

• Babel N, Schwarzmann F, Pruss A, Volk HD, Reinke P. Monoclonal gammopathy of undetermined significance (MGUS) is associated with an increased frequency of Epstein-Barr Virus (EBV) latently infected B lymphocytes in long-term renal transplant patients. Transplant Proc. 2004;36(9):2679–2682. doi:10.1016/j.transproceed.2004.09.04615621122
   PubMed Web of Science ®Google Scholar
• Tete SM, Bijl M, Sahota SS, Bos NA. Immune defects in the risk of infection and response to vaccination in monoclonal gammopathy of undetermined significance and multiple myeloma. Front Immunol. 2014;5:257. doi:10.3389/fimmu.2014.0025724917865
   PubMed Web of Science ®Google Scholar
• Kyle RA, Therneau TM, Rajkumar SV, et al. Prevalence of monoclonal gammopathy of undetermined significance. N Engl J Med. 2006;354(13):1362–1369. doi:10.1056/NEJMoa05449416571879
   PubMed Web of Science ®Google Scholar
• Blade J, Rosinol L, Cibeira MT, de Larrea CF. Pathogenesis and progression of monoclonal gammopathy of undetermined significance. Leukemia. 2008;22(9):1651–1657. doi:10.1038/sj.leu.240488918668131
   PubMed Web of Science ®Google Scholar
• Kristinsson SY, Tang M, Pfeiffer RM, et al. Monoclonal gammopathy of undetermined significance and risk of infections: a population-based study. Haematologica. 2012;97(6):854–858. doi:10.3324/haematol.2011.05401522180421
   PubMed Web of Science ®Google Scholar
• Isturiz RE, Schmoele-Thoma B, Scott DA, et al. Pneumococcal conjugate vaccine use in adults. Expert Rev Vaccines. 2016;15(3):279–293. doi:10.1586/14760584.2016.113217126651847
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Human medicine European public assessment report (EPAR): Prevenar 13. Amsterdam, The Netherlands: European Medicines Agency; 2009 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/001104/WC500152448.pdf. Accessed 1220, 2018.
   Google Scholar
• Bonten M, Bolkenbaas M, Huijts S, et al. Community acquired pneumonia immunisation trial in adults (CAPiTA). Pneumonia. 2014;3(ISPPD special issue):95.
   Google Scholar
• Pasiarski M, Rolinski J, Grywalska E, et al. Antibody and plasmablast response to 13-valent pneumococcal conjugate vaccine in chronic lymphocytic leukemia patients – preliminary report. PLoS One. 2014;9(12):e114966. doi:10.1371/journal.pone.011496625506837
   PubMed Web of Science ®Google Scholar
• Kyle RA, Durie BG, Rajkumar SV, et al.; for International Myeloma Working Group. Monoclonal gammopathy of undetermined significance (MGUS) and smoldering (asymptomatic) multiple myeloma: IMWG consensus perspectives risk factors for progression and guidelines for monitoring and management. Leukemia. 2010;24(6):1121–1127. doi:10.1038/leu.2010.179.20410922
   PubMed Web of Science ®Google Scholar
• Cabrera Q, Macro M, Hebert B, Cornet E, Collignon A, Troussard X. Epidemiology of monoclonal gammopathy of undetermined significance (MGUS): the experience from the specialized registry of hematologic malignancies of Basse-Normandie (France). Cancer Epidemiol. 2014;38(4):354–356. doi:10.1016/j.canep.2014.04.00624880205
   PubMed Web of Science ®Google Scholar
• Rajkumar SV. Updated diagnostic criteria and staging system for multiple myeloma. Am Soc Clin Oncol Educ Book. 2016;35:e418–23. doi:10.1200/EDBK_15900927249749
   PubMedGoogle Scholar
• Chovancova Z, Vlkova M, Litzman J, Lokaj J, Thon V. Antibody forming cells and plasmablasts in peripheral blood in CVID patients after vaccination. Vaccine. 2011;29(24):4142–4150. doi:10.1016/j.vaccine.2011.03.08721473955
   PubMed Web of Science ®Google Scholar
• He XS, Sasaki S, Narvaez CF, et al. Plasmablast-derived polyclonal antibody response after influenza vaccination. J Immunol Methods. 2011;365(1–2):67–75. doi:10.1016/j.jim.2010.12.00821182843
   PubMed Web of Science ®Google Scholar
• Camous X, Visan L, Ying CTT, et al. Healthy elderly Singaporeans show no age-related humoral hyporesponsiveness nor diminished plasmablast generation in response to influenza vaccine. Immun Ageing. 2018;15:28. doi:10.1186/s12979-018-0137-430455722
   PubMed Web of Science ®Google Scholar
• Ju CH, Blum LK, Kongpachith S, et al. Plasmablast antibody repertoires in elderly influenza vaccine responders exhibit restricted diversity but increased breadth of binding across influenza strains. Clin Immunol. 2018;193:70–79. doi:10.1016/j.clim.2018.01.01129410330
   PubMed Web of Science ®Google Scholar
• Obermoser G, Presnell S, Domico K, et al. Systems scale interactive exploration reveals quantitative and qualitative differences in response to influenza and pneumococcal vaccines. Immunity. 2013;38(4):831–844. doi:10.1016/j.immuni.2012.12.00823601689
   PubMed Web of Science ®Google Scholar
• Rahman A, Rashu R, Bhuiyan TR, et al. Antibody-secreting cell responses after Vibrio cholerae O1 infection and oral cholera vaccination in adults in Bangladesh. Clin Vaccine Immunol. 2013;20(10):1592–1598. doi:10.1128/CVI.00347-1323945156
   PubMedGoogle Scholar
• Lavinder JJ, Wine Y, Giesecke C, et al. Identification and characterization of the constituent human serum antibodies elicited by vaccination. Proc Natl Acad Sci USA. 2014;111(6):2259–2264. doi:10.1073/pnas.131779311124469811
   PubMed Web of Science ®Google Scholar
• van Mens SP, Meijvis SC, Endeman H, et al. Longitudinal analysis of pneumococcal antibodies during community-acquired pneumonia reveals a much higher involvement of Streptococcus pneumoniae than estimated by conventional methods alone. Clin Vaccine Immunol. 2011;18(5):796–801. doi:10.1128/CVI.00007-1121367978
   PubMedGoogle Scholar
• Pauksens K, Nilsson AC, Caubet M, et al. Randomized controlled study of the safety and immunogenicity of pneumococcal vaccine formulations containing PhtD and detoxified pneumolysin with alum or adjuvant system AS02V in elderly adults. Clin Vaccine Immunol. 2014;21(5):651–660. doi:10.1128/CVI.00807-1324599529
   PubMed Web of Science ®Google Scholar
• Kitchin N, Remich SA, Peterson J, et al. A phase 2 study evaluating the safety, tolerability, and immunogenicity of two 3-dose regimens of a clostridium difficile vaccine in healthy US adults aged 65 to 85 years. Clin Infect Dis. 2019; ciz153 Epub 2019 May 24. doi10.1093/cid/ciz153.31125055
   PubMed Web of Science ®Google Scholar
• Huang L, Chen Z, Hu Y, et al. Safety, immunogenicity, and lot-to-lot consistency of live attenuated varicella vaccine in 1-3 years old children: a double-blind, randomized phase III trial. Hum Vaccin Immunother. 2019;15(4):822–827. doi:10.1080/21645515.2018.155170130481106
   PubMed Web of Science ®Google Scholar
• Vanderkooi OG, Scheifele DW, Girgenti D, et al.; for Canadian PCV13 Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada. Pediatr Infect Dis J. 2012;31(1):72–77. doi:10.1097/INF.0b013e318233049d.21960186
   PubMed Web of Science ®Google Scholar
• Nelson LS, Steussy B, Morris CS, Krasowski MD. Effect of specimen type on free immunoglobulin light chains analysis on the Roche Diagnostics cobas 8000 analyzer. Springerplus. 2015;4:760. doi:10.1186/s40064-015-1546-x26682113
   PubMedGoogle Scholar
• Hartkamp A, Mulder AH, Rijkers GT, van Velzen-Blad H, Biesma DH. Antibody responses to pneumococcal and haemophilus vaccinations in patients with B-cell chronic lymphocytic leukaemia. Vaccine. 2001;19(13–14):1671–1677. doi:10.1016/s0264-410x(00)00409-611166890
   PubMed Web of Science ®Google Scholar
• Safdar A, Rodriguez GH, Rueda AM, et al. Multiple-dose granulocyte-macrophage-colony-stimulating factor plus 23-valent polysaccharide pneumococcal vaccine in patients with chronic lymphocytic leukemia: a prospective, randomized trial of safety and immunogenicity. Cancer. 2008;113(2):383–387. doi:10.1002/cncr.2356118470901
   PubMed Web of Science ®Google Scholar
• Bida JP, Kyle RA, Therneau TM, et al. Disease associations with monoclonal gammopathy of undetermined significance: a population-based study of 17,398 patients. Mayo Clin Proc. 2009;84(8):685–693. doi:10.4065/84.8.68519648385
   PubMed Web of Science ®Google Scholar
• Landgren O, Rapkin JS, Mellemkjaer L, Gridley G, Goldin LR, Engels EA. Respiratory tract infections in the pathway to multiple myeloma: a population-based study in Scandinavia. Haematologica. 2006;91(12):1697–1700.17145609
   PubMed Web of Science ®Google Scholar
• Rajkumar SV, Dimopulos MA, Palumbo A, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014;15(12):538–548. doi:10.1016/S1470-2045(13)70510-2
   PubMed Web of Science ®Google Scholar
• Shah D, Mustafa S, Bress J, Jamshed S. Comparison of response to vaccination with PCV 13 in patients with multiple myeloma versus healthy controls. Blood. 2017;130(Suppl 1):5418.
   Google Scholar
• Hayward S, Thompson LA, McEachern A. Is 13-valent Pneumococcal Conjugate Vaccine (PCV13) combined with 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) superior to PPSV23 alone for reducing incidence or severity of pneumonia in older adults? A clin-IQ. J Patient Cent Res Rev. 2016;3(2):111–115. doi:10.17294/2330-0698.121427376105
   PubMedGoogle Scholar
• Gregersen H, Madsen KM, Sørensen HT, Schønheyder HC, Ibsen JS, Dahlerup JF. The risk of bacteremia in patients with monoclonal gammopathy of undetermined significance. Eur J Haematol. 1998;61(2):140–144. doi:10.1111/j.1600-0609.1998.tb01075.x9714528
   PubMed Web of Science ®Google Scholar
• Karlsson J, Andréasson B, Kondori N, et al. Comparative study of immune status to infectious agents in elderly patients with multiple myeloma, Waldenstrom’s macroglobulinemia, and monoclonal gammopathy of undetermined significance. Clin Vaccine Immunol. 2011;18(6):969–977. doi:10.1128/CVI.00021-1121508164
   PubMedGoogle Scholar
• Augustson BM, Begum G, Dunn JA, et al. Early mortality after diagnosis of multiple myeloma: analysis of patients entered onto the United Kingdom Medical Research Council trials between 1980 and 2002–Medical Research Council Adult Leukaemia Working Party. J Clin Oncol. 2005;23(36):9219–9226. doi:10.1200/JCO.2005.03.208616275935
   PubMed Web of Science ®Google Scholar
• Terpos E, Chari A, Rifkin RM, et al. Uncovering the blind spot of clinical trials: first report of baseline characteristics of Newly Diagnosed (ND) and Relapsed/Refractory (RR) Multiple Myeloma (MM) Patients (Pts) in Insight-MM, a Global, Prospective, Observational Study. Blood. 2017;130(Suppl 1):5419.
   Google Scholar
• Merlini G, Palladini G. Differential diagnosis of monoclonal gammopathy of undetermined significance. Hematology Am Soc Hematol Educ Program. 2012;2012:595–603.23233640
   PubMed Web of Science ®Google Scholar