Effect on cellular and humoral immune responses of the AS03 adjuvant system in an A/H1N1/2009 influenza virus vaccine administered to adults during two randomized controlled trials

Clinical and Vaccine Immunology

Volumn 18, Issue 5, 2011, Pages 835-843

  Roman, François ^a   Clément, Frédéric ^b   Dewé, Walthère ^a   Walravens, Karl ^a   Maes, Cathy ^b   Willekens, Julie ^b   De Boever, Fien ^b   Hanon, Emmanuel ^a   Leroux Roels, Geert ^b  

^a GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^b GHENT UNIVERSITY HOSPITAL   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

HEMAGGLUTINATION INHIBITING ANTIBODY; IMMUNOLOGICAL ADJUVANT; IMMUNOLOGICAL ADJUVANT AS03; INFLUENZA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; UNCLASSIFIED DRUG;

2009 H1N1 INFLUENZA; ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; CELLULAR IMMUNITY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG SAFETY; FATIGUE; FEMALE; FLU LIKE SYNDROME; HEMAGGLUTINATION INHIBITION; HUMAN; HUMORAL IMMUNITY; IMMUNOGENICITY; INFLUENZA VACCINATION; INFLUENZA VIRUS A H1N1; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALAISE; MALE; MYALGIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ANTIBODIES, VIRAL; CALIFORNIA; CD4-POSITIVE T-LYMPHOCYTES; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; IMMUNIZATION, SECONDARY; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; MALE; MIDDLE AGED; TOCOPHEROLS; VACCINATION; YOUNG ADULT;

EID: 79955717327     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00480-10     Document Type: Article

References (41)

1. Banzhoff, A., et al. 2009. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One 4:e4384.
2. Baras, B., et al. 2008. Crossprotection against lethal H5N1 challenge in ferrets with an adjuvanted pandemic influenza vaccine. PLoS One 3:e1401.
3. Bresson, J. L., et al. 2006. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 367:1657-1664.
4. Carrat, F., and A. Flahault. 2007. Influenza vaccine: the challenge of antigenic drift. Vaccine 25:6852-6862. (Pubitemid 47398929)
5. Chattopadhyay, P. K., J. Yu, and M. Roederer. 2005. A live-cell assay to detect antigen-specific CD4+ T cells with diverse cytokine profiles. Nat. Med. 11:1113-1117.
6. Chu, D. W., et al. 2009. Immunogenicity and tolerability of an AS03-adjuvanted prepandemic influenza vaccine. A phase III study in a large population of Asian adults. Vaccine 27:7428-7435.
7. Clark, T. W., et al. 2009. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N. Engl. J. Med. 361:2424-2435.
8. Cowling, B. J., et al. 2010. Protective efficacy of seasonal influenza vaccination against seasonal and pandemic influenza virus infection during 2009 in Hong Kong. Clin. Infect. Dis. 51:1370-1379.
9. European Committee for Proprietary Medicinal Products. 24 January 2007, posting date. Guideline on influenza vaccine prepared from viruses with the potential to cause a pandemic and intended for use outside the core dossier context (EMEA/CHMP/VWP/263499/2006). European Agency for the Evaluation of Medicinal Products, London, United Kingdom.
10. FDA. 2007. Vaccines and related biological products advisory committee presentation on Sanofi Pasteur's H5N1 vaccine, p. 20. U.S. Food and Drug Administration. http://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4282S1 -6.ppt. Accessed 13 April 2010.
11. Frentsch, M., et al. 2005. Direct access to CD4+ T cells specific for defined antigens according to CD154 expression. Nat. Med. 11:1118-1124.
12. Garçon, N., P. Chomez, and M. Van Mechelen. 2007. GlaxoSmithKline adjuvant systems in vaccines: concepts, achievements and perspectives. Expert Rev. Vaccines 6:723-739. (Pubitemid 47607848)
13. Garten, R. J., et al. 2009. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science 325: 197-201.
14. Goodwin, K., C. Viboud, and L. Simonsen. 2006. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine 24:1159-1169. (Pubitemid 43202262)
15. Greenbaum, J. A., et al. 2009. Pre-existing immunity against swine-origin H1N1 influenza viruses in the general human population. Proc. Natl. Acad. Sci. U. S. A. 106:20365-20370.
16. Greenberg, M. E., et al. 2009. Response to a monovalent 2009 influenza A (H1N1) vaccine. N. Engl. J. Med. 2009. 361:2405-2413.
17. Hancock, K., et al. 2009. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N. Engl. J. Med. 361:1945-1952.
18. Harandi, A. M., G. Davies, and O. F. Olesen. 2009. Vaccine adjuvants: scientific challenges and strategic initiatives. Expert Rev. Vaccines 8:293-298.
19. Hehme, N. W., et al. 2002. Ten years of experience with the trivalent split-influenza vaccine, Fluarix™. Clin. Drug Invest. 22:751-769.
20. Kirchhoff, D., et al. 2007. Identification and isolation of murine antigen-reactive T cells according to CD154 expression. Eur. J. Immunol. 37:2370-2377.
21. Leroux-Roels, I., et al. 2008. Broad clade 2 cross-reactive immunity induced by an adjuvanted clade 1 rH5N1 pandemic influenza vaccine. PLoS One 3:e1665.
22. Leroux-Roels, I., et al. 2007. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine. Lancet 370:580-589. (Pubitemid 47247854)
23. A-adjuvanted H5N1 influenza vaccine improves the kinetics, magnitude and durability of the immune response after a heterologous booster vaccination: an open non-randomised extension of a double-blind randomized primary study. Vaccine 28:849-857.
24. Levie, K., et al. 2008. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J. Infect. Dis. 198:642-649.
25. Maecker, H. T., V. C. Maino, and L. J. Picker. 2000. Immunofluorescence analysis of T-cell responses in health and disease. J. Clin. Immunol. 20:391-399.
26. McElhaney, J. E. 2009. Prevention of infectious diseases in older adults through immunization: the challenge of the senescent immune response. Expert Rev. Vaccines 8:593-606.
27. McElhaney, J. E., and J. P. Dutz. 2008. Better influenza vaccines for older people: what will it take? J. Infect. Dis. 198:632-634.
28. Nolan, T., et al. 2008. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine 26:6383-6391.
29. Plennevaux, E., E. Sheldon, M. Blatter, M. K. Reeves-Hoché, and M. Denis. 2010. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet 375:41-48.
30. Roman, F., et al. 2010. Immunogenicity and safety in adults of one dose of influenza A H1N1v 2009 vaccine formulated with and without AS03A-adjuvant: preliminary report of an observer-blind, randomised trial. Vaccine 28:1740-1745.
31. Roman, F., T. Vaman, F. Kafeja, E. Hanon, and P. Van Damme. 2010. AS03A-adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age. Clin. Infect. Dis. 51:668-677.
32. Rümke, H. C., et al. 2008. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine 26:2378-2388.
33. Schwarz, T. F., et al. 2009. Single dose vaccination with AS03-adjuvanted H5N1 vaccines in a randomized trial induces strong and broad immune responsiveness to booster vaccination in adults. Vaccine 27:6284-6290.
34. Thompson, W. W., et al. 2004. Influenza-associated hospitalizations in the United States. JAMA 292:1333-1340. (Pubitemid 39223224)
35. Thompson, W. W., et al. 2003. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 289:179-186. (Pubitemid 36068705)
36. Treanor, J. J., J. D. Campbell, K. M. Zangwill, T. Rowe, and M. Wolff. 2006. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N. Engl. J. Med. 354:1345-1351.
37. Vogel, F. R., C. Caillet, I. C. Kusters, and J. Haensler. 2009. Emulsion based adjuvants for influenza vaccines. Expert Rev. Vaccines 8:483-492.
38. Waldrop, S. L., K. A. Davis, V. C. Maino, and L. J. Picker. 1998. Normal human CD4+ memory T-cells display broad heterogeneity in their activation threshold for cytokine synthesis. J. Immunol. 161:5284-5295.
39. Weinberger, B., D. Herndler-Brandstetter, A. Schwanninger, D. Weiskopf, and B. Grubeck-Loebenstein. 2008. Biology of immune responses to vaccines in elderly persons. Clin. Infect. Dis. 46:1078-1084.
40. World Health Organization. 27 May 2009, posting date. Availability of a candidate reassortant vaccine virus for the novel influenza A (H1N1) vaccine development X-179A. World Health Organization, Geneva, Switzerland. http://www.who.int/csr/resources/publications/swineflu/candidates-X-179a/en /.Accessed 13 April 2010.
41. Wrammert, J., et al. 2008. Rapid cloning of high-affinity human monoclonal antibodies against influenza virus. Nature 453:667-671. (Pubitemid 351769295)