Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: A phase IV, randomized, open-label, controlled study

Vaccine

Volumn 33, Issue 24, 2015, Pages 2800-2807

  Izurieta, Patricia ^a   Kim, Woo Joo ^b   Wie, Seong Heon ^c   Lee, Jacob ^d   Lee, Jin Soo ^e   Dramé, Mamadou ^f   Vaughn, David W ^f   Schuind, Anne ^f  

^a GSK   (Belgium)

^b Korea University College of Medicine   (South Korea)

^c The Catholic University of Korea College of Medicine   (South Korea)

^d Hallym University College of Medicine   (South Korea)

^e Inha University School of Medicine   (South Korea)

^f GLAXOSMITHKLINE   (United States)

Author keywords

AS03; H5N1 vaccine; Korean adults; Pandemic influenza

Indexed keywords

HEMAGGLUTINATION INHIBITING ANTIBODY; INFLUENZA VACCINE; ALPHA TOCOPHEROL; ASO3B ADJUVANT; DRUG COMBINATION; IMMUNOLOGICAL ADJUVANT; INACTIVATED VACCINE; POLYSORBATE; SQUALENE; VIRUS ANTIBODY;

ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CONTROLLED STUDY; DRUG SAFETY; DYSPEPSIA; FEMALE; GASTROENTERITIS; HUMAN; IMMUNOGENICITY; INFLUENZA A (H5N1); INFLUENZA VACCINATION; INJECTION SITE PRURITUS; MALE; MULTICENTER STUDY; PHARYNGITIS; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RHINORRHEA; SEROCONVERSION; ADOLESCENT; ANTIBODY PRODUCTION; BLOOD; CLINICAL TRIAL; DRUG COMBINATION; HEMAGGLUTINATION INHIBITION TEST; IMMUNIZATION; IMMUNOLOGY; INFLUENZA A VIRUS (H5N1); INFLUENZA, HUMAN; MIDDLE AGED; NORTH KOREA; PANDEMICS; VACCINATION; YOUNG ADULT;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ALPHA-TOCOPHEROL; ANTIBODIES, VIRAL; ANTIBODY FORMATION; DEMOCRATIC PEOPLE'S REPUBLIC OF KOREA; DRUG COMBINATIONS; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; IMMUNIZATION SCHEDULE; INFLUENZA A VIRUS, H5N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; PANDEMICS; POLYSORBATES; SQUALENE; VACCINATION; VACCINES, INACTIVATED; YOUNG ADULT;

EID: 84929262391     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.04.027     Document Type: Article

References (37)

1. World Health Organization Cumulative number of confirmed human cases for avian influenza A(H5N1) reported to WHO, 2003-2014 2014, 27 July.
2. Food and Drug Administration FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza 2013, 〈http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376444.htm〉 [accessed 20 November 2014].
3. US Food and Drug Administration H5N1 Influenza Virus Vaccine, manufactured by Sanofi Pasteur, Inc. Questions and Answers 2013, 〈http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm080753.htm〉 [accessed 20 November 2014].
4. Chu D.W., Hwang S.J., Lim F.S., 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, 27:7428-7435. 10.1016/j.vaccine.2009.07.102.
5. Díez-Domingo J., Garcés-Sanchez M., Baldó J.-M., et al. Immunogenicity and safety of H5N1 A/Vietnam/1194/2004 (clade 1) AS03-adjuvanted pre-pandemic candidate influenza vaccines in children aged 3 to 9 years: a phase II, randomized, open, controlled study. Pediatr Infect Dis J 2010, 29:e35-e46. 10.1097/INF.0b013e3181daf921.
6. Langley J.M., Frenette L., Ferguson L., et al. Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults. J Infect Dis 2010, 201:1644-1653. 10.1016/j.vaccine.2012.03.046.
7. Langley J.M., Risi G., Caldwell M., et al. Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study. J Infect Dis 2011, 203:1729-1738. 10.1093/infdis/jir172.
8. Leroux-Roels I., Borkowski A., Vanwolleghem T., et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007, 370:580-589. 10.1016/S0140-6736(07)61297-5.
9. Nolan T., Izurieta P., Lee B.W., et al. Heterologous Prime-boost vaccination using an AS03B-adjuvanted influenza A(H5N1) vaccine in infants and children <3 years of age. J Infect Dis 2014, 210:1800-1810. 10.1093/infdis/jiu359.
10. Vaughn D., Seifert H., Hepburn A., et al. Safety of AS03-adjuvanted inactivated split virion A(H1N1)pdm09 and H5N1 influenza virus vaccines administered to adults: Pooled analysis of 28 clinical trials. Hum Vaccines Immunother 2014, 10:2942-2957. Published online: 21 Nov. 10.4161/21645515.2014.972149.
11. 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. 10.1371/journal.pone.0001665.
12. Gillard P., Chu D.W., Hwang S.J., et al. Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults. BMC Infect Dis 2014, 14:142. 10.1186/1471-2334-14-142.
13. European Medicines Agency. European Committee for Proprietary Medicinal Products. Note for guidance on harmonisation of requirements for influenza vaccines. 〈http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003945.pdf〉 [accessed 20 November 2014]. in press.
14. Kendal A., Pereira M., Skehel J. Hemagglutination inhibition. Concepts and procedures for laboratory-based influenza surveillance 1982, B17-B35. Centers for Disease Control and Prevention and Pan-American Health Organization, Atlanta, GA. A.P. Kendal, M.S. Pereira, J.J. Skehel (Eds.).
15. Rowe T., Abernathy R.A., Hu-Primmer J., et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 1999, 37:937-943.
16. Stephenson I., Wood J.M., Nicholson K.G., Charlett A., Zambon M.C. Detection of anti-H5 responses in human sera by HI using horse erythrocytes following MF59-adjuvanted influenza A/Duck/Singapore/97 vaccine. Virus Res 2004, 103:91-95. doi: S0168170204001182.
17. Hehme N., Künzel W., Petschke F., Türk G., Raderecht C., van Hoecke C., et al. Ten years of experience with the trivalent split-influenza vaccine, Fluarix™. Clin Drug Invest 2002, 22:751-769.
18. US Food and Drug Administration Clinical data needed to support the licensure of pandemic influenza vaccines 2007, 〈http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074794.htm〉 [accessed 20 November 2014].
19. Yang P.C., Yu C.J., Chang S.C., et al. Safety and immunogenicity of a split-virion AS03A-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine in Taiwanese adults. J Formos Med Assoc 2012, 111:333-339. 10.1016/j.jfma.2011.02.006.
20. Bresson J.L., Perronne C., Launay O., et al. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 2006, 367:1657-1664. 10.1016/S0140-6736(06)68656-X.
21. Treanor J.J., Campbell J.D., Zangwill K.M., Rowe T., Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006, 354:1343-1351. 10.1056/NEJMoa055778.
22. Rumke H.C., Bayas J.M., de Juanes J.R., et al. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine 2008, 26:2378-2388. 10.1016/j.vaccine.2008.02.068.
23. Ferguson N.M., Cummings D.A., Fraser C., Cajka J.C., Cooley P.C., Burke D.S. Strategies for mitigating an influenza pandemic. Nature 2006, 442:448-452. 10.1038/nature04795.
24. Jennings L.C., Monto A.S., Chan P.K., Szucs T.D., Nicholson K.G. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infect Dis 2008, 8:650-658. 10.1016/S1473-3099(08)70232-9.
25. Godeaux O., Izurieta P., Madariaga M., Drame M., Li P., Vaughn D.W. Immunogenicity and safety of AS03-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years. Vaccine 2015, 33:2189-2195. Jul 30 [Epub ahead of print]. 10.1016/j.vaccine.2014.07.062.
26. Gillard P., Caplanusi A., Knuf M., et al. An assessment of prime-boost vaccination schedules with AS03A -adjuvanted prepandemic H5N1 vaccines: a randomized study in European adults. Influenza Other Respir Viruses 2013, 7:55-65. 10.1111/j.1750-2659.2012.00349.x.
27. Leroux-Roels I., Roman F., Forgus S., et al. Priming with AS03(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 randomised primary study. Vaccine 2010, 28:849-857. Epub 2009 Oct 14. 10.1016/j.vaccine.2009.10.017.
28. Nolan T., Richmond P.C., Formica N.T., et al. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine 2008, 26:6383-6391. 10.1016/j.vaccine.2008.08.046.
29. Plennevaux E., Sheldon E., Blatter M., Reeves-Hoche M.K., Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet 2010, 375:41-48. 10.1016/S0140-6736(09)62026-2.
30. Roman F., Vaman T., Kafeja F., Hanon E., Van Damme P. AS03(A)-adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age. Clin Infect Dis 2010, 51:668-677. 10.1086/655830.
31. Kwon D., Lee J.Y., Choi W., Choi J.H., Chung Y.S., Lee N.J., et al. Avian influenza a (H5N1) virus antibodies in poultry cullers, South Korea, 2003-2004. Emerg Infect Dis 2012, 18:986-988. 10.3201/eid1806.111631.
32. Toner E.S., Adalja A.A., Nuzzo J.B., Inglesby T.V., Henderson D.A., Burke D.S. Assessment of serosurveys for H5N1. Clin Infect Dis 2013, 56:1206-1212. 10.1093/cid/cit047.
33. Duffy J., Weintraub E., Vellozzi C., DeStefano F. Narcolepsy and influenza A(H1N1) pandemic 2009 vaccination in the United States. Neurology 2014, 83:1823-1830. 10.1212/WNL.0000000000000987.
34. European Centre for Disease Control and Prevention Narcolepsy in association with pandemic vaccination; a multi-country European epidemiological investigation 2012, 〈http://www.ecdc.europa.eu/en/publications/Publications/Vaesco%20report%20FINAL%20with%20cover.pdf〉 [accessed 13 March 2015].
35. Miller E., Andrews N., Stellitano L., Stowe J., Winstone A.M., Shneerson J., et al. Risk of narcolepsy in children and young people receiving AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine: retrospective analysis. BMJ 2013, 346:f794. 10.1136/bmj.f794.
36. Nohynek H., Jokinen J., Partinen M., Vaarala O., Kirjavainen T., Sundman J., et al. AS03 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland. PLoS ONE 2012, 7:e33536. 10.1371/journal.pone.0033536.
37. Partinen M., Saarenpaa-Heikkila O., Ilveskoski I., Hublin C., Linna M., Olsen P., et al. Increased incidence and clinical picture of childhood narcolepsy following the 2009 H1N1 pandemic vaccination campaign in Finland. PLoS ONE 2012, 7:e33723. 10.1371/journal.pone.0033723.