Immunogenicity and safety of a two-dose schedule of whole-virion and AS03A-adjuvanted 2009 influenza A (H1N1) vaccines: A randomised, multicentre, age-stratified, head-to-head trial

The Lancet Infectious Diseases

Volumn 11, Issue 2, 2011, Pages 91-101

  Nicholson, Karl G ^a   Abrams, Keith R ^b   Batham, Sally ^a   Clark, Tristan W ^a   Hoschler, Katja ^c   Lim, Wei Shen ^d   Medina, Marie Jo ^a   Nguyen Van Tam, Jonathan S ^e   Read, Robert C ^f   Warren, Fiona C ^b   Zambon, Maria ^c  

^a UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

^b UNIVERSITY OF LEICESTER   (United Kingdom)

^c PUBLIC HEALTH ENGLAND   (United Kingdom)

^d NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^e UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^f UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADJUVANT; ANTIGEN; HEMAGGLUTININ; INFLUENZA VACCINE; OIL; WATER;

ADULT; AGED; ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; BREAST CANCER; CHILL; COMPUTER ANALYSIS; CONTROLLED STUDY; DRUG FEVER; DRUG SAFETY; ESOPHAGUS CANCER; FEMALE; GOVERNMENT; HEADACHE; HEMAGGLUTINATION INHIBITION; HOSPITAL; HUMAN; IMMUNOGENICITY; INFLUENZA A (H1N1); INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE SWELLING; MALAISE; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; NORMAL HUMAN; PANDEMIC INFLUENZA; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; TREATMENT OUTCOME; UNITED KINGDOM; VACCINATION; VIRION; VOMITING;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, VIRAL; FEMALE; GREAT BRITAIN; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; IMMUNIZATION, SECONDARY; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; VACCINATION; VACCINES, INACTIVATED; VACCINES, SUBUNIT; YOUNG ADULT;

EID: 78751704276     PISSN: 14733099     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1473-3099(10)70296-6     Document Type: Article

References (37)

1. Dawood FS, Jain S, Finelli L, et al. Emergence of a novel swine origin influenza A virus in humans. N Engl J Med 2009, 360:2605-2615.
2. Recommended viruses for influenza vaccines for use in 2010-2011 northern hemisphere season WHO, (accessed Nov 30, 2010). http://www.who.int/csr/disease/influenza/201002_Recommendation.pdf.
3. Vesikari T, Pellegrini M, Karvonen A, et al. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis 2009, 28:563-571.
4. Bernstein DI, Zahradnik JM, DeAngelis C, et al. Clinical reactions and serologic responses after vaccination with whole-virus or split-virus influenza vaccines in children aged 6 to 36 months. Pediatrics 1982, 69:404-408.
5. Atmar RL, Keitel WA, Patel SM, et al. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza H9N2 vaccine preparations. Clin Infect Dis 2006, 43:1135-1142.
6. Nicholson KG, Colegate AE, Podda A, et al. Safety and antigenicity of non-adjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a randomized trial of two potential vaccines against H5N1 influenza. Lancet 2001, 357:1937-1943.
7. 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.
8. Stephenson I, Nicholson KG, Gluck R, et al. Safety and antigenicity of whole virus and subunit influenza A/Hong Kong/1073/99 (H9N2) vaccine in healthy adults: phase I randomised trial. Lancet 2003, 362:1959-1966.
9. Parkman PD, Hopps HE, Rastogi S, et al. Summary of clinical trials of influenza virus vaccines in adults. J Infect Dis 1977, 136:S722-S730.
10. Barry DW, Mayner RE, Staton E, et al. Comparative trial of influenza vaccine: immunogenicity of whole virus and split product vaccines in man. Am J Epidemiol 1976, 104:34-46.
11. Lin J, Zhang J, Dong X, et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet 2006, 368:991-997.
12. Nolan T, McVernon J, Skeljo M, et al. Immunogenicity of a monovalent 2009 Influenza A (H1N1) vaccine in infants and children: a randomized trial. JAMA 2010, 303:37-46.
13. Clark TW, Pareek M, Hoschler K, et al. Trial of 2009 influenza A H1N1 monovalent MF59-adjuvanted vaccine. N Engl J Med 2009, 361:2424-2435.
14. Greenburg ME, Lai MH, Hartel G, et al. Response to monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med 2009, 361:2405-2410.
15. Zhu FC, Wang H, Fang HH, et al. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med 2009, 361:2414-2423.
16. Liang XF, Wang HQ, Wang JZ, 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.
17. Plennevaux E, Sheldon E, Blatter M, et al. 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.
18. Haaheim L Original antigenic sin: a confounding issue?. Dev Biol (Basel) 2003, 115:49-53.
19. Stephenson I, Heath A, Major D, et al. Reproducibility of serologic assays for influenza virus A (H5N1). Emerg Infect Dis 2009, 15:1252-1259.
20. Waddington CS, Oeser C, Reiner A, et al. Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ 2010, 340:c2649.
21. Rowe T, Abernathy RA, 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.
22. Ellis JS, Zambon MC Molecular investigation of an outbreak of influenza in the United Kingdom. Eur J Epidemiol 1997, 13:369-372.
23. Note for guidance on harmonisation of requirements for influenza vaccines (CPMP/BWP/214/96) Committee for Proprietary Medicinal Products, (accessed Nov 30, 2010). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003945.pdf.
24. Guideline on dossier structure and content for pandemic vaccine marketing authorisation (CPMP/VEG/4717/03) Committee for Proprietary Medicinal Products, (accessed Nov 30, 2010). http://archives.who.int/prioritymeds/report/append/62EMEAguidelines.pdf.
25. Hobson D, Curry RL, Beare AS, Ward-Gardner A The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg (Lond) 1972, 70:767-777.
26. Coudeville L, Bailleux F, Riche B, Megas F, Andre P, Ecochard R Relationship between haemagglutination inhibiting antibody titres and clinical protection against influenza: development and application of a bayesian random-effects model. BMC Med Res Methodol 2010, 10:18.
27. Waddington CS, Andrews N, Hoschler K, et al. Open-label, randomised, parallel group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03B/oil-in-water emulsion-adjuvanted (AS03B) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age. Health Technol Assess 2010, 14:1-130.
28. Hancock K, Veguilla V, Lu X, et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med 2009, 361:1945-1952.
29. Miller E, Hoschler K, Hardelid P, Stanford E, Andrews N, Zambon M Incidence of 2009 pandemic influenza A H1N1 infection in England: a cross-sectional serological study. Lancet 2010, 375:1100-1108.
30. Frey S, Poland G, Percell S, et al. Comparison of the safety, tolerability and immunogenicity of MF59-adjuvanted and non-adjuvanted influenza vaccine in non-elderly adults. Vaccine 2003, 21:4234-4237.
31. Nolan T, Richmond PC, Formica NT, 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.
32. Leroux-Roels I, Roman F, Forgus S, et al. Priming with AS03-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.
33. Sambhara S, McElhany JE Immunosenescence and influenza vaccine efficacy. Curr Top Microbiol Immunol 2009, 333:413-429.
34. Clinical aspects of pandemic 2009 influenza A (H1N1) virus infection. N Engl J Med 2010, 362:1708-1719. Writing Committee of the WHO Consultation on Clinical Aspects of Pandemic (H1N1) 2009 Influenza.
35. Hanquet G, Van Damme P, Brasseur D, et al. Lessons learnt from pandemic A(H1N1) 2009 influenza vaccination: highlights of a European workshop in Brussels (22 March 2010). Vaccine 2010; published online Nov 12. doi:10.1016/j.vaccine.2010.10.079.
36. Influenza update-24 September 2010 WHO, (accessed Nov 30, 2010). http://www.who.int/csr/disease/influenza/2010_09_24_GIP_surveillance/en/index.html.
37. Twenty-second pandemic pharmacovigilance update European Medicines Agency, (accessed Sept 17, 2010). http://www.ema.europa.eu/influenza/updates.html.