Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults

Vaccine

Volumn 35, Issue 2, 2017, Pages 313-320

  Song, Joon Young ^a   Cheong, Hee Jin ^a   Hyun, Hak Jun ^a   Seo, Yu Bin ^b   Lee, Jacob ^b   Wie, Seong Heon ^c   Choi, Min Joo ^a   Choi, Won Suk ^a   Noh, Ji Yun ^a   Yun, Jae Won ^a   Yun, Jin Gu ^a   Kim, Woo Joo ^a  

^a Korea University College of Medicine   (South Korea)

^b Hallym University College of Medicine   (South Korea)

^c The Catholic University of Korea   (South Korea)

Author keywords

Emulsion adjuvant; Influenza vaccine; MF59; Pneumococcal conjugate vaccine

Indexed keywords

INACTIVATED VACCINE; INFLUENZA VACCINE; MIFAMURTIDE; PNEUMOCOCCUS VACCINE; 13-VALENT PNEUMOCOCCAL VACCINE; IMMUNOLOGICAL ADJUVANT; MF59 OIL EMULSION; POLYSORBATE; SQUALENE;

ADULT; AGED; ANTIBODY RESPONSE; ARTHRALGIA; ARTICLE; CHILL; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG SAFETY; FATIGUE; FEMALE; HEADACHE; HEMAGGLUTINATION INHIBITION; HUMAN; IMMUNOGENICITY; INFLUENZA A (H1N1); INFLUENZA A (H3N2); INFLUENZA B; INFLUENZA VACCINATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE REDNESS; MALAISE; MALE; MULTICENTER STUDY; MYALGIA; NORMAL HUMAN; OPEN STUDY; OPSONIZATION; OPSONOPHAGOCYTIC ACTIVITY ASSAY; PNEUMOCOCCAL INFECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SEROTYPE; VACCINATION REACTION; ADVERSE DRUG REACTION; ANTIBODY PRODUCTION; CLINICAL TRIAL; DRUG INTERACTION; HEMAGGLUTINATION INHIBITION TEST; IMMUNIZATION; IMMUNOLOGY; MIDDLE AGED; PHAGOCYTOSIS; VERY ELDERLY;

ADJUVANTS, IMMUNOLOGIC; AGED; AGED, 80 AND OVER; ANTIBODY FORMATION; DRUG INTERACTIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; IMMUNIZATION SCHEDULE; INFLUENZA VACCINES; MALE; MIDDLE AGED; PHAGOCYTOSIS; PNEUMOCOCCAL VACCINES; POLYSORBATES; SQUALENE; VACCINES, INACTIVATED;

EID: 85007016488     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.11.047     Document Type: Article

References (34)

1. [1] Fedson, D.S., Nicolas-Spony, L., Klemets, P., van der Linden, M., Marques, A., Salleras, L., et al. Pneumococcal polysaccharide vaccination for adults: new perspectives for Europe. Expert Rev Vaccines 10 (2011), 1143–1167.
2. [2] Song, J.Y., Cheong, H.J., Heo, J.Y., Noh, J.Y., Seo, Y.B., Kim, I.S., et al. Outpatient-based pneumococcal vaccine campaign and survey of perceptions about pneumococcal vaccination in patients and doctors. Yonsei Med J 54 (2013), 469–475.
3. [3] Song, J.Y., Cheong, H.J., Tsai, T.F., Chang, H.A., Choi, M.J., Jeon, J.H., et al. Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults. Vaccine 33 (2015), 4647–4652.
4. [4] Tomczyk, S., Bennett, N.M., Stoecker, C., Gierke, R., Moore, M.R., Whitney, C.G., et al. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ⩾65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 63 (2014), 822–825.
5. [5] Dagan, R., Poolman, J., Siegrist, C.A., Glycoconjugate vaccines and immune interference: a review. Vaccine 28 (2010), 5513–5523.
6. [6] Frenck, R.W. Jr, Gurtman, A., Rubino, J., Smith, W., van Cleeff, M., Jayawardene, D., et al. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol 19 (2012), 1296–1303.
7. [7] Schwarz, T.F., Flamaing, J., Rümke, H.C., Penzes, J., Juergens, C., Wenz, A., et al. A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged ⩾65 years. Vaccine 29 (2011), 5195–5202.
8. [8] Schwarz, T.F., Schmoele-Thoma, B., Assessment of functional antibacterial opsonophagocytic antibodies elicited by 13-valent pneumococcal conjugate vaccine administered concomitantly with trivalent influenza vaccine in a randomized clinical trial in adults aged ⩾65 years. Vaccine 31 (2013), 291–294.
9. [9] Manzoli, L., Ioannidis, J.P., Flacco, M.E., De Vito, C., Villari, P., Effectiveness and harms of seasonal and pandemic influenza vaccines in children, adults and elderly: a critical review and re-analysis of 15 meta-analyses. Hum Vaccine Immunother 8 (2012), 851–862.
10. [10] Kelvin, D.J., Farooqui, A., Extremely low vaccine effectiveness against influenza H3N2 in the elderly during the 2012/2013 flu season. J Infect Dev Ctries 7 (2013), 299–301.
11. [11] Treanor, J.J., Talbot, H.K., Ohmit, S.E., Coleman, L.A., Thompson, M.G., Cheng, P.Y., et al. Effectiveness of seasonal influenza vaccines in the United States during a season with circulation of all three vaccine strains. Clin Infect Dis 55 (2012), 951–959.
12. [12] Fry, A.M., Kim, I.K., Reed, C., Thompson, M., Chaves, S.S., Finelli, L., et al. Modeling the effect of different vaccine effectiveness estimates on the number of vaccine-prevented influenza-associated hospitalizations in older adults. Clin Infect Dis 59 (2014), 406–409.
13. [13] Del Giudice, G., Rappuoli, R., Inactivated and adjuvanted influenza vaccines. Curr Top Microbiol Immunol 386 (2015), 151–180.
14. [14] Frey, S.E., Reyes, M.R., Reynales, H., Bermal, N.N., Nicolay, U., Narasimhan, V., et al. Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine 32 (2014), 5027–5034.
15. [15] Mannino, S., Villa, M., Apolone, G., Weiss, N.S., Groth, N., Aquino, I., et al. Effectiveness of adjuvanted influenza vaccination in elderly subjects in northern Italy. Am J Epidemiol 176 (2012), 527–533.
16. [16] Seo, Y.B., Choi, W.S., Lee, J., Song, J.Y., Cheong, H.J., Kim, W.J., Comparison of the immunogenicity and safety of the conventional subunit, MF59-adjuvanted, and intradermal influenza vaccines in the elderly. Clin Vaccine Immunol 21 (2014), 989–996.
17. [17] Spadea, A., Unim, B., Colamesta, V., Meneghini, A., D'Amici, A.M., Giudiceandrea, B., et al. Is the adjuvanted influenza vaccine more effective than the trivalent inactivated vaccine in the elderly population? Results of a case-control study. Vaccine 32 (2014), 5290–5294.
18. [18] Cox, N.J., Ziegler, T., Influenza viruses. Murray, P.R., Baron, E.J., American Society for Microbiology, (eds.) Manual of clinical microbiology, 8th ed., 2003, ASM Press, Washington, D.C., 1360–1365.
19. [19] Committee for Proprietary Medicinal Products. Note for guidance on harmonisation of requirements for influenza vaccines (CPMP/BWP/214/96). Available at: < http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003945.pdf> [accessed 17 August 2010].
20. [20] Cooper, D., Yu, X., Sidhu, M., Nahm, M.H., Fernsten, P., Jansen, K.U., The 13-valent pneumococcal conjugate vaccine (PCV13) elicits cross-functional opsonophagocytic killing responses in humans to Streptococcus pneumoniae serotypes 6C and 7A. Vaccine 29 (2011), 7207–7211.
21. [21] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Available at: < https://www.federalregister.gov/articles/2007/09/27/E7-19155/guidance-for-industry-toxicity-grading-scale-for-healthy-adult-and-adolescent-volunteers-enrolled-in> [accessed 17 August 2010].
22. [22] Joseph, C., Togawa, Y., Shindo, N., Bacterial and viral infections associated with influenza. Influenza Other Respir Viruses 7:Suppl. 2 (2013), 105–113.
23. [23] VaiWpp-N. Releve epidemiologique hebdomadaire/Section d'hygiene du Secretariat de la Societe des Nations = Weekly epidemiological record/Health Section of the Secretariat of the League of Nations 2012;87:461–76.
24. [24] McCullers, J.A., Rehg, J.E., Lethal synergism between influenza virus and Streptococcus pneumoniae: characterization of a mouse model and the role of platelet-activating factor receptor. J Infect Dis 186 (2002), 341–350.
25. [25] Walter, N.D., Taylor, T.H., Shay, D.K., Thompson, W.W., Brammer, L., Dowell, S.F., et al. Influenza circulation and the burden of invasive pneumococcal pneumonia during a non-pandemic period in the United States. Clin Infect Dis 50 (2010), 175–183.
26. [26] Gilchrist, S.A., Nanni, A., Levine, O., Benefits and effectiveness of administering pneumococcal polysaccharide vaccine with seasonal influenza vaccine: an approach for policymakers. Am J Publ Health 102 (2012), 596–605.
27. [27] Christenson, B., Lundbergh, P., Hedlund, J., Ortqvist, A., Effects of a large-scale intervention with influenza and 23-valent pneumococcal vaccines in adults aged 65 years or older: a prospective study. Lancet 357 (2001), 1008–1011.
28. [28] Christenson, B., Hedlund, J., Lundbergh, P., Ortqvist, A., Additive preventive effect of influenza and pneumococcal vaccines in elderly persons. Eur Respir J 23 (2004), 363–368.
29. [29] Dominguez, A., Castilla, J., Godoy, P., Delgado-Rodriguez, M., Saez, M., Soldevila, N., et al. Effectiveness of vaccination with 23-valent pneumococcal polysaccharide vaccine in preventing hospitalization with laboratory confirmed influenza during the 2009–2010 and 2010–2011 seasons. Hum Vaccine Immunother 9 (2013), 865–873.
30. [30] Geno, K.A., Gilbert, G.L., Song, J.Y., Skovsted, I.C., Klugman, K.P., Jones, C., et al. Pneumococcal capsules and their types: past, present, and future. Clin Microbiol Rev 28 (2015), 871–899.
31. [31] Clutterbuck, E.A., Lazarus, R., Yu, L.M., Bowman, J., Bateman, E.A., Diggle, L., et al. Pneumococcal conjugate and plain polysaccharide vaccines have divergent effects on antigen-specific B cells. J Infect Dis 205 (2012), 1408–1416.
32. [32] Destefano, F., Goodman, R.A., Noble, G.R., Mcclary, G.D., Smith, S.J., Broome, C.V., Simultaneous administration of influenza and pneumococcal vaccines. JAMA 247 (1982), 2551–2554.
33. [33] Tsai, T.F., Fluad®-MF59®-adjuvanted influenza vaccine in older adults. Infect Chemother 45 (2013), 159–174.
34. [34] O'Hagan, D.T., Ott, G.S., De Gregorio, E., Seubert, A., The mechanism of action of MF59 – an innately attractive adjuvant formulation. Vaccine 30 (2012), 4341–4348.