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http://dx.doi.org/10.3346/jkms.2018.33.e340

Validation of a Multiplexed Opsonophagocytic Assay for 11 Additional Pneumococcal Serotypes and Its Application to Functional Antibody Evaluation Induced by Pneumococcal Polysaccharide Vaccine  

Cha, Jihei (Department of Pediatrics, Ewha Womans University College of Medicine)
Kim, Han Wool (Department of Pediatrics, Ewha Womans University College of Medicine)
Lee, Ji Hyen (Department of Pediatrics, Ewha Womans University College of Medicine)
Lee, Soyoung (Department of Pediatrics, Ewha Womans University College of Medicine)
Kim, Kyung-Hyo (Department of Pediatrics, Ewha Womans University College of Medicine)
Publication Information
Journal of Korean Medical Science / v.33, no.51, 2018 , pp. 340.1-340.14 More about this Journal
Abstract
Background: Various pneumococcal vaccines have been evaluated for immunogenicity by opsonophagocytic assay (OPA). A multiplexed OPA (MOPA) for 13 pneumococcal serotypes was developed by Nahm and Burton, and expanded to 26 serotypes in 2012. The development of new conjugate vaccines with increased valence has necessitated expanded MOPAs to include these additional serotypes. In this study, we validated this expanded MOPA platform and applied to measure antibodies against 11 additional serotypes (2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20B, 22F, and 33F) in human sera. Methods: All materials, including serum, complement, bacterial master stocks, and HL-60 cells, were evaluated for assay optimization. Following optimization, the assay was validated for accuracy, specificity, and intra- and inter-assay precision with sera from adult donors following standard protocols. The assay was applied to evaluate functional antibodies of 42 sera immunized with 23-valent pneumococcal polysaccharide vaccine (PPV23). Results: The expanded MOPA platform was specific for all serotypes, with the exception of serotype 20. The assay results were highly correlated with those obtained from single-serotype OPA, indicating acceptable accuracy. The coefficients of variation were 7%-24% and 13%-39% in tests of intra- and inter-assay precision, respectively, using three quality-control samples. A MOPA that included 11 additional serotypes in the PPV23 was established and validated with respect to accuracy, specificity, and precision. The opsonic indices of immune sera were obtained using this validated assay. Conclusion: The expanded MOPA will be useful for evaluation of the immunogenicity of PPV23 and future conjugate vaccine formulations.
Keywords
Pneumococcal Vaccines; Immunogenicity; Opsonin Proteins; Biologic Assay; Validation Studies;
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1 Klugman KP, Black S, Dagan R, Malley R, Whitney CG. Pneumococcal vaccine. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 6th ed. Philadelphia, PA: Elsevier Health Sciences; 2013, 504-41. A Multiplexed OPA for 11 Additional Pneumococcal Serotypes
2 Fedson DS, Scott JA. The burden of pneumococcal disease among adults in developed and developing countries: what is and is not known. Vaccine 1999;17 Suppl 1:S11-8.
3 Lee H, Nahm MH, Burton R, Kim KH. Immune response in infants to the heptavalent pneumococcal conjugate vaccine against vaccine-related serotypes 6A and 19A. Clin Vaccine Immunol 2009;16(3):376-81.   DOI
4 Kyaw MH, Jones IG, Campbell H. Prevention of pneumococcal disease in children. Pneumococcal conjugate vaccines: their use globally could have a major impact on public health. Acta Paediatr 2001;90(5):473-6.   DOI
5 Ortqvist A. Pneumococcal vaccination: current and future issues. Eur Respir J 2001;18(1):184-95.   DOI
6 Peters TR, Edwards KM. Pneumococcal vaccines: present and future. Pediatr Ann 2002;31(4):261-8.   DOI
7 Butler JC, Breiman RF, Campbell JF, Lipman HB, Broome CV, Facklam RR. Pneumococcal polysaccharide vaccine efficacy. An evaluation of current recommendations. JAMA 1993;270(15):1826-31.   DOI
8 Puumalainen T, Ekstrom N, Zeta-Capeding R, Ollgren J, Jousimies K, Lucero M, et al. Functional antibodies elicited by an 11-valent diphtheria-tetanus toxoid-conjugated pneumococcal vaccine. J Infect Dis 2003;187(11):1704-8.   DOI
9 Rennels MB, Edwards KM, Keyserling HL, Reisinger KS, Hogerman DA, Madore DV, et al. Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants. Pediatrics 1998;101(4 Pt 1):604-11.   DOI
10 Shinefield HR, Black S, Ray P, Chang I, Lewis N, Fireman B, et al. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr Infect Dis J 1999;18(9):757-63.   DOI
11 Shinefield HR, Black S. Efficacy of pneumococcal conjugate vaccines in large scale field trials. Pediatr Infect Dis J 2000;19(4):394-7.   DOI
12 Whitney CG, Farley MM, Hadler J, Harrison LH, Bennett NM, Lynfield R, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med 2003;348(18):1737-46.   DOI
13 Esposito S, Tansey S, Thompson A, Razmpour A, Liang J, Jones TR, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine compared to those of a 7-valent pneumococcal conjugate vaccine given as a three-dose series with routine vaccines in healthy infants and toddlers. Clin Vaccine Immunol 2010;17(6):1017-26.   DOI
14 Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J 2009;28(4 Suppl):S109-18.   DOI
15 Harboe ZB, Benfield TL, Valentiner-Branth P, Hjuler T, Lambertsen L, Kaltoft M, et al. Temporal trends in invasive pneumococcal disease and pneumococcal serotypes over 7 decades. Clin Infect Dis 2010;50(3):329-37.   DOI
16 Navarro Torne A, Dias JG, Quinten C, Hruba F, Busana MC, Lopalco PL, et al. European enhanced surveillance of invasive pneumococcal disease in 2010: data from 26 European countries in the post-heptavalent conjugate vaccine era. Vaccine 2014;32(29):3644-50.   DOI
17 Waight PA, Andrews NJ, Ladhani SN, Sheppard CL, Slack MP, Miller E. Effect of the 13-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in England and Wales 4 years after its introduction: an observational cohort study. Lancet Infect Dis 2015;15(5):535-43.   DOI
18 Mendes RE, Costello AJ, Jacobs MR, Biek D, Critchley IA, Jones RN. Serotype distribution and antimicrobial susceptibility of USA Streptococcus pneumoniae isolates collected prior to and post introduction of 13-valent pneumococcal conjugate vaccine. Diagn Microbiol Infect Dis 2014;80(1):19-25.   DOI
19 Rosen JB, Thomas AR, Lexau CA, Reingold A, Hadler JL, Harrison LH, et al. Geographic variation in invasive pneumococcal disease following pneumococcal conjugate vaccine introduction in the United States. Clin Infect Dis 2011;53(2):137-43.   DOI
20 O'Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, McCall N, et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 2009;374(9693):893-902.   DOI
21 van Hoek AJ, Sheppard CL, Andrews NJ, Waight PA, Slack MP, Harrison TG, et al. Pneumococcal carriage in children and adults two years after introduction of the thirteen valent pneumococcal conjugate vaccine in England. Vaccine 2014;32(34):4349-55.   DOI
22 Kawaguchiya M, Urushibara N, Aung MS, Morimoto S, Ito M, Kudo K, et al. Emerging non-PCV13 serotypes of noninvasive Streptococcus pneumoniae with macrolide resistance genes in northern Japan. New Microbes New Infect 2015;9:66-72.
23 Ben-Shimol S, Greenberg D, Givon-Lavi N, Schlesinger Y, Somekh E, Aviner S, et al. Early impact of sequential introduction of 7-valent and 13-valent pneumococcal conjugate vaccine on IPD in Israeli children <5 years: an active prospective nationwide surveillance. Vaccine 2014;32(27):3452-9.   DOI
24 Jodar L, Butler J, Carlone G, Dagan R, Goldblatt D, Kayhty H, et al. Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants. Vaccine 2003;21(23):3265-72.   DOI
25 Golden AR, Adam HJ, Gilmour MW, Baxter MR, Martin I, Nichol KA, et al. Assessment of multidrug resistance, clonality and virulence in non-PCV-13 Streptococcus pneumoniae serotypes in Canada, 2011-13. J Antimicrob Chemother 2015;70(7):1960-4.   DOI
26 Varon E, Cohen R, Bechet S, Doit C, Levy C. Invasive disease potential of pneumococci before and after the 13-valent pneumococcal conjugate vaccine implementation in children. Vaccine 2015;33(46):6178-85.   DOI
27 Skinner JM, Indrawati L, Cannon J, Blue J, Winters M, Macnair J, et al. Pre-clinical evaluation of a 15-valent pneumococcal conjugate vaccine (PCV15-CRM197) in an infant-rhesus monkey immunogenicity model. Vaccine 2011;29(48):8870-6.   DOI
28 Romero-Steiner S, Frasch CE, Carlone G, Fleck RA, Goldblatt D, Nahm MH. Use of opsonophagocytosis for serological evaluation of pneumococcal vaccines. Clin Vaccine Immunol 2006;13(2):165-9.   DOI
29 Rubins JB, Alter M, Loch J, Janoff EN. Determination of antibody responses of elderly adults to all 23 capsular polysaccharides after pneumococcal vaccination. Infect Immun 1999;67(11):5979-84.
30 Burton RL, Nahm MH. Development and validation of a fourfold multiplexed opsonization assay (MOPA4) for pneumococcal antibodies. Clin Vaccine Immunol 2006;13(9):1004-9.   DOI
31 Gallagher R, Collins S, Trujillo J, McCredie K, Ahearn M, Tsai S, et al. Characterization of the continuous, differentiating myeloid cell line (HL-60) from a patient with acute promyelocytic leukemia. Blood 1979;54(3):713-33.
32 Findlay JW, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal 2000;21(6):1249-73.   DOI
33 Romero-Steiner S, Libutti D, Pais LB, Dykes J, Anderson P, Whitin JC, et al. Standardization of an opsonophagocytic assay for the measurement of functional antibody activity against Streptococcus pneumoniae using differentiated HL-60 cells. Clin Diagn Lab Immunol 1997;4(4):415-22.
34 Burton RL, Nahm MH. Development of a fourfold multiplexed opsonophagocytosis assay for pneumococcal antibodies against additional serotypes and discovery of serological subtypes in Streptococcus pneumoniae serotype 20. Clin Vaccine Immunol 2012;19(6):835-41.   DOI
35 Calix JJ, Porambo RJ, Brady AM, Larson TR, Yother J, Abeygunwardana C, et al. Biochemical, genetic, and serological characterization of two capsule subtypes among Streptococcus pneumoniae serotype 20 strains: discovery of a new pneumococcal serotype. J Biol Chem 2012;287(33):27885-94.   DOI
36 Henckaerts I, Durant N, De Grave D, Schuerman L, Poolman J. Validation of a routine opsonophagocytosis assay to predict invasive pneumococcal disease efficacy of conjugate vaccine in children. Vaccine 2007;25(13):2518-27.   DOI
37 Gijzen K, Liu WM, Visontai I, Oftung F, van der Werf S, Korsvold GE, et al. Standardization and validation of assays determining cellular immune responses against influenza. Vaccine 2010;28(19):3416-22.   DOI
38 Li G, Liang Q, Shi J, Hu Y, Li H, Wei W, et al. Safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine in 2 to 70 year old healthy people in China: a phase III double blind, randomized clinical trial. Hum Vaccin Immunother 2015;11(3):699-703.   DOI
39 Fleck RA, Romero-Steiner S, Nahm MH. Use of HL-60 cell line to measure opsonic capacity of pneumococcal antibodies. Clin Diagn Lab Immunol 2005;12(1):19-27.   DOI
40 Lee S, Kim HW, Lee JH, Kim KH. Functional immune responses to 11 non-PCV13 serotypes after immunization with a 23-valent pneumococcal polysaccharide vaccine in older adults. Vaccine 2017;35(37):4960-5.   DOI
41 Pilishvili T, Lexau C, Farley MM, Hadler J, Harrison LH, Bennett NM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis 2010;201(1):32-41.   DOI
42 McFetridge R, Meulen AS, Folkerth SD, Hoekstra JA, Dallas M, Hoover PA, et al. Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults. Vaccine 2015;33(24):2793-9.   DOI
43 Burton RL, Antonello J, Cooper D, Goldblatt D, Kim KH, Plikaytis BD, et al. Assignment of opsonic values to pneumococcal reference serum 007sp for use in opsonophagocytic assays for 13 serotypes. Clin Vaccine Immunol 2017;24(2):e00457-00516.