Immunogenicity profile of a 3.75-μg hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: A randomized trial

Journal of Infectious Diseases

Volumn 203, Issue 8, 2011, Pages 1054-1062

  Heijmans, Stéphane ^a   De Meulemeester, Marc ^a   Reynders, Paul ^a   Giet, Didier ^a   Demanet, Etienne ^a   Devresse, Pierre Yves ^a   Icardi, Giancarlo ^c   Dramé, Mamadou ^b   Roman, Francxois ^b   Gillard, Paul ^b  

^a ResearchLink   (Belgium)

^b GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^c UNIVERSITY OF GENOA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

HEMAGGLUTINATION INHIBITING ANTIBODY; INFLUENZA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; NEUTRALIZING ANTIBODY;

ADULT; AGED; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CD4+ T LYMPHOCYTE; CELLULAR IMMUNITY; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG SAFETY; FEMALE; HEMAGGLUTINATION INHIBITION; HUMAN; IMMUNOGENICITY; MALE; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SINGLE DRUG DOSE; UNSPECIFIED SIDE EFFECT;

AGED; AGED, 80 AND OVER; FEMALE; HEMAGGLUTININS; HUMANS; INFLUENZA A VIRUS, H5N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED;

EID: 79953301948     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jiq174     Document Type: Article

References (27)

1. Ferguson NM, Cummings DA, Fraser C, Cajka JC, Cooley PC, Burke DS. Strategies for mitigating an influenza pandemic. Nature 2006; 442:448-52. (Pubitemid 44264793)
2. Germann TC, Kadau K, Longini IM Jr., Macken CA. Mitigation strategies for pandemic influenza in the United States. Proc Natl Acad Sci USA 2006; 103:5935-40.
3. Jennings LC, Monto AS, Chan PK, Szucs TD, Nicholson KG. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infect Dis 2008; 8:650-8.
4. European Committee for Proprietary Medicinal Products. Committee for Medicinal Products for Human Use post-authorisation summary of positive opinion for Prepandrix (EMEA/CHMP/334055/2009). Published London, May 2009. Available at: http://www.emea.europa.eu/pdfs/human/opinion/Prepandrix-33405509en.pdf. Accessed 1 September 2009.
5. Leroux-Roels I, Borkowski A, Vanwolleghem T, et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine. Lancet 2007; 370:580-9. (Pubitemid 47247854)
6. Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine. N Engl J Med 2006; 354:1345-51.
7. Leroux-Roels I, Bernhard R, Gerard P, Drame M, Hanon E, Leroux-Roels G. Broad clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine. PLoS One 2008; 3:e1665.
8. A-adjuvanted H5N1 vaccines in a randomized trial induces strong and broad immune responsiveness to booster vaccination in adults. Vaccine 2009; 27:6284-90.
9. Chu DW, Hwang SJ, Lim FS, et al. Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine 2009; 27:7428-35.
10. Diez-Domingo J, Garcés-Sanchez M, Baldó J-M, et al. Immunogenicity and safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-adjuvanted prepandemic candidate influenza vaccines in children aged 3 to 9 years: a phase II, randomized, open, controlled study. Pediatr Infect Dis J 2010; 29:DOI:10.1097/INF.0b013e3181daf921.
11. Rümke HC, Bayasb JM, de Juanesc JR, et al. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine 2008; 26:2378-88.
12. Weinberger B, Herndler-Brandstetter D, Schwanninger A, Weiskopf D, Grubeck-Loebenstein B. Biology of immune responses to vaccines in elderly persons. Clin Infect Dis 2008; 46:1078-84. (Pubitemid 351589876)
13. Hehme NW, Künzel W, Petschke F, et al. Ten years of experience with the trivalent split-influenza vaccine. Fluarix Clin Drug Invest 2002; 22:751-69. (Pubitemid 35388185)
14. Stephenson I, Heath A, Major D, et al. Reproducibility of serologic assays for influenza virus A (H5N1). Emerg Infect Dis 2009; 15:252-9.
15. Reed LJ, Muench H. A simple method of estimating fifty per cent endpoints. Am J Epidemiol 1938; 27:493-7.
16. Maecker HT, Maino VC, Picker LJ. Immunofluorescence analysis of T-cell responses in health and disease. J Clin Immun 2000; 20:391-9. (Pubitemid 32099703)
17. Hammarlund E, Lewis MW, Hanson SG, et al. Duration of antiviral immunity after smallpox vaccination. Nat Med 2003; 9:1131-7. (Pubitemid 37173696)
18. Chattopadhyay PK, Yu J, Roederer M. A live-cell assay to detect antigen- specific CD4+ T cells with diverse cytokine profiles. Nat Med 2005; 11:1113-7. (Pubitemid 41486835)
19. +T cells specific for defined antigens according to CD154 expresion. Nat Med 2005; 11:1118-24.
20. Gioia C, Castilletti C, Tempestilli M, et al. Cross-subtype immunity against avian influenza in persons recently vaccinated for influenza. Emerg Infect Dis 2008; 14:121-8.
21. Lee LYH, Ha DLA, Simmons C, et al. Memory T cells established by seasonal human influenza A infection cross-react with avian influenza A (H5N1) in healthy individuals. J Clin Invest 2008; 118:3478-90.
22. Roti M, Yang J, Berger DA, Huston L, James EA, Kwok WK. Healthy human subjects have CD4+ T cells directed against H5N1 virus. J Immunol 2008; 180:1758-68.
23. Corti D, Suguitan AL Jr., Pinna D, et al. Heterosubtypic neutralizing antibodies are produced by individuals immunized with a seasonal influenza vaccine. J Clin Invest 2010; 120:1663-73.
24. Rowe T, Abernathy RA, Hu-Primmer J, et al. Detection of anti-body to avian influenza A (H5N1) virus in human serum by using a Q1 combination of serologic assays. J Clin Microbiol 1999; 37:937-43. (Pubitemid 29140593)
25. McElhaney JE, Xie D, Hager WD, et al. T cell responses are better correlates of vaccine protection in the elderly. J Immunol 2006; 176:6333-9.
26. McElhaney JE, Dutz JP. Better influenza vaccines for older people: what will it take? J Infect Dis 2008; 198:632-4.
27. McElhaney JE, Ewen C, Zhou X, et al. Granzyme B: correlates with protection and enhanced CTL response to influenza vaccination in older adults. Vaccine 2009; 27:2418-25.