Evaluation of immune response following one dose of an AS03 A-adjuvanted H1N1 2009 pandemic influenza vaccine in Japanese adults 65 years of age or older

Human Vaccines and Immunotherapeutics

Volumn 8, Issue 8, 2012, Pages 1119-1125

  Ikematsu, Hideyuki ^a   Tenjinbaru, Kazuyoshi ^b   Li, Ping ^c   Madan, Anuradha ^c   Vaughn, David ^c  

^a Hara Doi Hospital   (Japan)

^b Development and Medical Affairs Division   (Japan)

^c GLAXOSMITHKLINE   (United States)

Author keywords

Adjuvant; Adults; AS03; Elderly; H1N1; Influenza; Japan; Pandemic

Indexed keywords

HEMAGGLUTININ; IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE;

AGED; ANTIBODY TITER; ARTICLE; DOSE RESPONSE; DRUG SAFETY; FATIGUE; FEMALE; HEADACHE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE PAIN; JAPANESE; LONG TERM CARE; MALE; MYALGIA; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 4 CLINICAL TRIAL; SEROCONVERSION; SINGLE DRUG DOSE; VACCINATION; VIROGENESIS; VIRUS NEUTRALIZATION;

ADJUVANTS, IMMUNOLOGIC; AGED; AGED, 80 AND OVER; ALPHA-TOCOPHEROL; ASIAN CONTINENTAL ANCESTRY GROUP; FEMALE; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; OILS; SQUALENE;

EID: 84866117691     PISSN: None     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.21081     Document Type: Article

References (37)

1. Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, et al.; Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. [Erratum in: N Engl J Med 2009; 361:102]. N Engl J Med 2009; 360:2605-15; PMID:19423869; http://dx.doi.org/10.1056/NEJMoa0903810.
2. Garten RJ, Davis CT, Russell CA, Shu B, Lindstrom S, Balish A, et al. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science 2009; 325:197-201; PMID:19465683; http://dx.doi.org/10.1126/science.1176225.
3. Katz J, Hancock K, Veguilla V, Zhong W, Lu XH, Sun H, et al.; Centers for Disease Control and Prevention (CDC). Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine. MMWR Morb Mortal Wkly Rep 2009; 58:521-4; PMID:19478718.
4. Hancock K, Veguilla V, Lu X, Zhong W, Butler EN, Sun H, et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med 2009; 361:1945-52; PMID:19745214; http://dx.doi.org/10.1056/ NEJMoa0906453.
5. Centers for Disease Control and Prevention (CDC). Updated estimates of 2009 H1N1 influenza cases, hospitalizations and deaths in the United States, April 2009 - April 10, 2010. Available at: http://www.cdc.gov/h1n1flu/estimates- 2009-h1n1.htm. Accessed on February 16, 2012.
6. Wada K, Nishiura H, Kawana A. An epidemiological analysis of severe cases of the influenza A (H1N1) 2009 virus infection in Japan. Influenza Other Respi Viruses 2010; 4:179-86; PMID:20836793; http://dx.doi.org/10.1111/j.1750-2659. 2010.00143.x.
7. Ministry of Health. Labour and Welfare (MHLW); Press Release (August 11, 2010). Available at: http://www.mhlw.go.jp/kinkyu/kenkou/influenza/houdou/2010/ 08/dl/infuh0811-01.pdf. Accessed on February 16, 2012. Japanese.
8. Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 2009; 361:2424-35; PMID:19745215; http://dx.doi.org/10.1056/NEJMoa0907650.
9. Liang XF, Wang HQ, Wang JZ, Fang HH, Wu J, Zhu FC, et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet 2010; 375:56-66; PMID:20018364; http://dx.doi.org/10.1016/S0140-6736(09)62003-1.
10. Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet 2010; 375:49-55; PMID:20018367; http://dx.doi.org/10.1016/S0140-6736(09)62039-0.
11. World Health Organization (WHO). Global Alert and Response (GAR). Pandemic influenza A (H1N1) 2009 virus vaccine - conclusions and recommendations from the October 2009 meeting of the immunization Strategic Advisory Group of Experts, December 04, 2009. Available at: http://www.who.int/csr/disease/ swineflu/meetings/sage-oct-2009/en/. Accessed on February 16, 2012.
12. World Health Organization (WHO). WHO recommendations on pandemic (H1N1) 2009 vaccines. Pandemic (H1N1) 2009: briefing note 2. Available at: http://www.who.int/csr/disease/swineflu/notes/h1n1-vaccine-20090713/en/index. html. Accessed on February 16, 2012.
13. World Health Organization (WHO). Global Advisory Committee on Vaccine Safety, 16-17 June 2010. Wkly Epidemiol Rec 2010; 85:285-92.
14. Manzoli L, De Vito C, Salanti G, D'Addario M, Villari P, Ioannidis JPA. Meta-analysis of the immunogenicity and tolerability of pandemic influenza A 2009 (H1N1) vaccines. PLoS One 2011; 6:e24384; http://dx.doi.org/10.1371/ journal.pone.0024384; PMID:21915319.
15. Yin JK, Khandaker G, Rashid H, Heron L, Ridda I, Booy R. Immunogenicity and safety of pandemic influenza A (H1N1) 2009 vaccine: systematic review and meta-analysis. Influenza Other Respi Viruses 2011; 5:299-305; http://dx.doi.org/10.1111/j.1750-2659.2011.00229.x; PMID:21668694.
16. Chu DWS, Hwang SJ, Lim FS, Oh HML, Thongcharoen P, Yang PC, et al.; H5N1 Flu Study Group for Hong Kong, Singapore, Taiwan and Thailand. 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; PMID:19683087; http://dx.doi.org/10.1016/j.vaccine.2009.07.102.
17. Nagai H, Ikematsu H, Tenjinbaru K, Maeda A, Dramé M, Roman FP. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis 2010; 10:338; PMID:21108818; http://dx.doi.org/10.1186/ 1471-2334-10-338.
18. Leroux-Roels I, Bernhard R, Gérard P, Dramé 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; PMID:18301743; http://dx.doi.org/10.1371/journal.pone.0001665.
19. Roman F, Vaman T, Gerlach B, Markendorf A, Gillard P, Devaster JM. 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 2010; 28:1740-5; PMID:20034605; http://dx.doi.org/10.1016/j.vaccine.2009.12.014.
20. Roman F, Clément F, Dewé W, Walravens K, Maes C, Willekens J, et al. 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. Clin Vaccine Immunol 2011; 18:835-43; PMID:21450978; http://dx.doi.org/10.1128/CVI.00480-10.
21. A)-adjuvanted H1N1 2009 pandemic influenza vaccine in adults in Japan. Hum Vaccin 2010; 6:888-93; PMID:20980795; http://dx.doi.org/10.4161/hv.6.11.12851.
22. A-adjuvanted 2009 influenza A (H1N1) vaccines: a randomised, multicentre, age-stratified, head-to-head trial. Lancet Infect Dis 2011; 11:91-101; PMID:21168369; http://dx.doi.org/10.1016/S1473-3099(10)70296-6.
23. Ferguson M, Risi G, Davis M, Sheldon E, Baron M, Li P, et al. Safety and long-term humoral immune response in adults after vaccination with an H1N1 2009 pandemic influenza vaccine with or without AS03 adjuvant. J Infect Dis 2012; 205:733-44; PMID:22315336; http://dx.doi.org/10.1093/infdis/jir641.
24. Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, et al. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis 2010; 202:1327-37; PMID:20874515; http://dx.doi.org/10.1086/656601.
25. Ihara T. Evaluation of alum-adjuvanted whole virus influenza vaccine and future aspects of influenza A (H1N1) 2009 vaccine. Uirusu 2010; 60:69-78; http://www.flutrackers.com/forum/showthread.php?t=152740;PMID:20848866; http://dx.doi.org/10.2222/jsv.60.69.
26. Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, et al. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA 2010; 303:37-46; PMID:20026597; http://dx.doi.org/10.1001/jama.2009.1911.
27. Nolan T, Richmond PC, Formica NT, Höschler K, Skeljo MV, Stoney T, et al. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine 2008; 26:6383-91; PMID:18801398; http://dx.doi.org/10.1016/j.vaccine.2008.08.046.
28. Leroux-Roels G. Prepandemic H5N1 influenza vaccine adjuvanted with AS03: a review of the preclinical and clinical data. Expert Opin Biol Ther 2009; 9:1057-71; PMID:19555313; http://dx.doi.org/10.1517/14712590903066695.
29. Saitoh A, Tamura S, Nagai A, Tsuchida N, Sako M, Maekawa T, et al. Clinical evaluation of an AS03-adjuvanted pandemic influenza H1N1 2009 vaccine in children (Preliminary report). [Japanese.]. J Jap Pediatr Soc. 2011; 115:578-84.
30. Andrews NJ, Walker WT, Finn A, Heath PT, Pollard AJ, Snape MD, et al. Predictor of immune response and reactogenicity to AS03B- adjyuvanted split virion and non-adjuvanted whole virion H1N1. Vaccine 2011; 29:7913-9; PMID:21875635; http://dx.doi.org/10.1016/j.vaccine.2011.08.076.
31. Hirota Y, Kaji M. History of influenza vaccination programs in Japan. Vaccine 2008; 26:6451-4; PMID:18573292; http://dx.doi.org/10.1016/j.vaccine. 2008.06.042.
32. Hehme NW, Künzel W, Petschke F, Gisela T, Carmen R, Christian Van H, et al. Ten years of experience with the trivalent split-influenza vaccine, Fluarix™. Clin Drug Investig 2002; 22:751-69; http://dx.doi.org/10.2165/ 00044011-200222110-00004.
33. Leroux-Roels I, Borkowski A, Vanwolleghem T, Dramé M, Clement F, Hons E, et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007; 370:580-9; PMID:17707753; http://dx.doi.org/10.1016/S0140-6736(07) 61297-5.
34. Baras B, de Waal L, Stittelaar KJ, Jacob V, Giannini S, Kroeze EJ, et al. Pandemic H1N1 vaccine requires the use of an adjuvant to protect against challenge in naïve ferrets. Vaccine 2011; 29:2120-6; PMID:21238573; http://dx.doi.org/10.1016/j.vaccine.2010.12.125.
35. Reed LT, Muench H. A simple method of calculating fifty percent end point. Am J Hyg 1938; 27:493-8.
36. European Committee for Proprietary Medicinal Products (CHMP). Guideline on influenza vaccine prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context (EMEA/CHMP/VWP/263499/2006). European Agency for the Evaluation of Medicinal Products, January 24, 2007. Available at: http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2009/09/WC500003872.pdf
37. US Food and Drug Administration. (FDA) Guidance for Industry. Clinical data needed to support the licensure of pandemic influenza vaccines. US Food and Drug Administration May 2007. Available at: http://www.fda.gov/cber/gdlns/ panfluvac.htm