Cell culture (Vero cell) derived whole-virus non-adjuvanted H5N1 influenza vaccine induces long-lasting cross-reactive memory immune response: Homologous or heterologous booster response following two dose or single dose priming

Vaccine

Volumn 30, Issue 43, 2012, Pages 6127-6135

  van der Velden, Maikel V W ^a   Aichinger, Gerald ^a   Pöllabauer, Eva Maria ^a   Löw Baselli, Alexandra ^a   Fritsch, Sandor ^a   Benamara, Karima ^a   Kistner, Otfried ^a   Müller, Markus ^b   Zeitlinger, Markus ^b   Kollaritsch, Herwig ^c   Vesikari, Timo ^d   Ehrlich, Hartmut J ^a   Barrett, P Noel ^a  

^a BAXTER BIOSCIENCE   (Austria)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

^d UNIVERSITY OF TAMPERE MEDICAL SCHOOL   (Finland)

Author keywords

H5N1; Influenza; Pre pandemic; Prime boost; Vero; Whole virus

Indexed keywords

INACTIVATED VIRUS VACCINE; INFLUENZA VACCINE; UNCLASSIFIED DRUG; VERO CELL DERIVED WHOLE VIRUS NON ADJUVANTED H5N1 VACCINE;

ADULT; AGED; ANIMAL CELL; ANTIBODY RESPONSE; ANTIBODY TITER; ARTHRALGIA; ARTICLE; CELL CULTURE; CONTROLLED STUDY; CROSS PRESENTATION; CROSS REACTION; DRUG SAFETY; ECCHYMOSIS; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; HYPERHIDROSIS; IMMUNOGENICITY; IMMUNOLOGICAL MEMORY; INFLUENZA VIRUS A H5N1; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; MALAISE; MALE; MYALGIA; NONHUMAN; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SHIVERING; VACCINATION; VERO CELL; VIRUS STRAIN;

ADULT; ANIMALS; ANTIBODIES, VIRAL; ANTIBODY FORMATION; CERCOPITHECUS AETHIOPS; CROSS REACTIONS; FEMALE; HUMANS; IMMUNIZATION, SECONDARY; IMMUNOLOGIC MEMORY; INFLUENZA A VIRUS, H5N1 SUBTYPE; INFLUENZA VACCINES; MALE; MIDDLE AGED; NEUTRALIZATION TESTS; VERO CELLS; YOUNG ADULT;

EID: 84865752791     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.07.077     Document Type: Article

References (50)

1. Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO 2012, WHO, Available from: http://www.who.int/influenza/human_animal_interface/H5N1_cumulative_table_archives/en/index.html [accessed 11.06.12].
2. Watanabe Y., Ibrahim M.S., Ellakany H.F., Kawashita N., Mizuike R., Hiramatsu H., et al. Acquisition of human-type receptor binding specificity by new H5N1 influenza virus sublineages during their emergence in birds in Egypt. PLoS Pathog 2011, 7:e1002068.
3. Casadevall A., Shenk T. The H5N1 manuscript redaction controversy. MBio 2012, 3:e00022-12.
4. Inglesby T.V. Engineered H5N1: a rare time for restraint in science. Ann Intern Med 2012, 156:460-462.
5. Kawaoka Y. H5N1: flu transmission work is urgent. Nature 2012, 482:155.
6. Keim P.S. The NSABB recommendations: rationale, impact, and implications. MBio 2012, 3:e00021-12.
7. Pavia A.T. Laboratory creation of a highly transmissible H5N1 influenza virus: balancing substantial risks and real benefits. Ann Intern Med 2012, 156:463-465.
8. Racaniello V.R. Science should be in the public domain. MBio 2012, 3:e00004-12.
9. Webster R.G. Mammalian-transmissible H5N1 influenza: the dilemma of dual-use research. MBio 2012, 3:e00005-12.
10. Pandemic influenza preparedness and response: WHO guidance document 2012, WHO, Available from: http://www.who.int/influenza/resources/documents/pandemic_guidance_04_2009/en/ [accessed 07.02.12].
11. Gambotto A., Barratt-Boyes S.M., de Jong M.D., Neumann G., Kawaoka Y. Human infection with highly pathogenic H5N1 influenza virus. Lancet 2008, 371:1464-1475.
12. Abdel-Ghafar A.N., Chotpitayasunondh T., Gao Z., Hayden F.G., Nguyen D.H., de Jong M.D., et al. Update on avian influenza A (H5N1) virus infection in humans. N Engl J Med 2008, 358:261-273.
13. Ungchusak K., Auewarakul P., Dowell S.F., Kitphati R., Auwanit W., Puthavathana P., et al. Probable person-to-person transmission of avian influenza A (H5N1). N Engl J Med 2005, 352:333-340.
14. 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.
15. Responding to the avian influenza pandemic threat: recommended strategic actions 2012, WHO, Available from: http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_2005_8/en/ [accessed 07.02.12].
16. Antigenic and genetic characteristics of influenza A (H5N1) and influenza A (H9N2) viruses for development of candidate vaccines viruses for pandemic preparedness - February 2011. Wkly Epidemiol Rec 2011, 86:93-100.
17. Hehme N., Engelmann H., Kunzel W., Neumeier E., Sanger R. Pandemic preparedness: lessons learnt from H2N2 and H9N2 candidate vaccines. Med Microbiol Immunol 2002, 191:203-208.
18. Talaat K.R., Karron R.A., Callahan K.A., Luke C.J., DiLorenzo S.C., Chen G.L., et al. A live attenuated H7N3 influenza virus vaccine is well tolerated and immunogenic in a phase I trial in healthy adults. Vaccine 2009, 27:3744-3753.
19. Karron R.A., Callahan K., Luke C., Thumar B., McAuliffe J., Schappell E., et al. A live attenuated H9N2 influenza vaccine is well tolerated and immunogenic in healthy adults. J Infect Dis 2009, 199:711-716.
20. Kistner O., Barrett P.N., Mundt W., Reiter M., Schober-Bendixen S., Dorner F. Development of a mammalian cell (Vero) derived candidate influenza virus vaccine. Vaccine 1998, 16:960-968.
21. Wichmann B.A., Hill I.D. Algorithm AS 183: an efficient and portable pseudo-random number generator. Appl Stat 1982, 31:188-190.
22. McLeod A. Remark AS R58: a remark on algorithm AS 183. An efficient and portable pseudo-random number generator. Appl Stat 1985, 34:198-200.
23. Ehrlich H.J., Müller M., Oh H.M., Tambyah P.A., Joukhadar C., Montomoli E., et al. A clinical trial of a whole-virus H5N1 vaccine derived from cell culture. N Engl J Med 2008, 358:2573-2584.
24. Schild G.C., Pereira M.S., Chakraverty P. Single-radial-hemolysis: a new method for the assay of antibody to influenza haemagglutinin. Applications for diagnosis and seroepidemiologic surveillance of influenza. Bull World Health Organ 1975, 52:43-50.
25. Lu B.L., Webster R.G., Hinshaw V.S. Failure to detect hemagglutination-inhibiting antibodies with intact avian influenza virions. Infect Immun 1982, 38:530-535.
26. Wood J.M., Gaines-Das R.E., Taylor J., Chakraverty P. Comparison of influenza serological techniques by international collaborative study. Vaccine 1994, 12:167-174.
27. Committee for Proprietary Medicinal Products. Note for guidance on harmonisation of requirements for influenza vaccines. London, UK: European Agency for the Evaluation of Medicinal Products (EMEA), 1997 March 12. Report No.: CPMP/BWP/214/96.
28. Howard M.K., Sabarth N., Savidis-Dacho H., Portsmouth D., Kistner O., Kreil T.R., et al. H5N1 whole-virus vaccine induces neutralizing antibodies in humans which are protective in a mouse passive transfer model. PLoS One 2011, 6:e23791.
29. Germann T.C., Kadau K., Longini I.M., Macken C.A. Mitigation strategies for pandemic influenza in the United States. Proc Natl Acad Sci USA 2006, 103:5935-5940.
30. Ehrlich H.J., Müller M., Fritsch S., Zeitlinger M., Berezuk G., Löw-Baselli A., et al. A cell culture (Vero)-derived H5N1 whole-virus vaccine induces cross-reactive memory responses. J Infect Dis 2009, 200:1113-1118.
31. Crowe B.A., Brühl P., Gerencer M., Schwendinger M.G., Pilz A., Kistner O., et al. Evaluation of the cellular immune responses induced by a non-adjuvanted inactivated whole virus A/H5N1/VN/1203 pandemic influenza vaccine in humans. Vaccine 2010, 29:166-173.
32. Banzhoff A., Gasparini R., Laghi-Pasini F., Staniscia T., Durando P., Montomoli E., et al. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One 2009, 4:e4384.
33. Fragapane E., Gasparini R., Schioppa F., Laghi-Pasini F., Montomoli E., Banzhoff A. A heterologous MF59-adjuvanted H5N1 prepandemic influenza booster vaccine induces a robust, cross-reactive immune response in adults and the elderly. Clin Vaccine Immunol 2010, 17:1817-1819.
34. Galli G., Medini D., Borgogni E., Zedda L., Bardelli M., Malzone C., et al. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci USA 2009, 106:3877-3882.
35. Goji N.A., Nolan C., Hill H., Wolff M., Noah D.L., Williams T.B., et al. Immune responses of healthy subjects to a single dose of intramuscular inactivated influenza A/Vietnam/1203/2004 (H5N1) vaccine after priming with an antigenic variant. J Infect Dis 2008, 198:635-641.
36. Leroux-Roels I., Roman F., Forgus S., Maes C., De Boever F., Dramé M., et al. Priming with AS03A-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.
37. Risi G., Frenette L., Langley J.M., Li P., Riff D., Sheldon E., et al. Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months. Vaccine 2011, 29:6408-6418.
38. Zangwill K.M., Treanor J.J., Campbell J.D., Noah D.L., Ryea J. Evaluation of the safety and immunogenicity of a booster (third) dose of inactivated subvirion H5N1 influenza vaccine in humans. J Infect Dis 2008, 197:580-583.
39. Klein J. Responses dominated by B lymphocytes. In immunology. The science of self-nonself discrimination 1982, John Wiley & Sons, New York, p. 507-74.
40. Siegrist C. Vaccine immunology. Vaccines 2008, 17-36. Elsevier. 5th ed. S. Plotkin, W. Orenstein, P. Offit (Eds.).
41. Heyzer-Williams M., Okitsu S., Wang N., Heyzer-Williams L. Molecular programming of B cell memory. Nat Rev Immunol 2012, 12:24-34.
42. Pelletier N., McHeyzer-Williams L.J., Wong K.A., Urich E., Fazilleau N., Heyzer-Williams M.G. Plasma cells negatively regulate the follicular helper T cell program. Nat Immunol 2010, 11:1110-1118.
43. Schwarz T.F., Horacek T., Knuf M., Damman H.G., Roman F., Dramé M., et al. Single dose vaccination with AS03-adjuvanted H5N1 vaccines in a randomized trial induces strong and broad immune responsiveness to booster vaccination in adults. Vaccine 2009, 27:6284-6290.
44. Tambyah P.A., Wilder-Smith A., Pavlova B.G., Barrett P.N., Oh H.M., Hui D.S., et al. Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine. Vaccine 2012, 30:329-335.
45. Epstein S.L. Prior H1N1 influenza infection and susceptibility of Cleveland Family Study participants during the H2N2 pandemic of 1957: an experiment of nature. J Infect Dis 2006, 193:49-53.
46. Langley J.M., Risi G., Caldwell M., Gilderman L., Berwald B., Fogarty C., 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.
47. Bresson J.L., Perronne C., Launay O., Gerdil C., Saville M., Wood J., 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.
48. Leroux-Roels I., Borkowski A., Vanwolleghem T., Drame 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, 370:580-589.
49. Lin J., Zhang J., Dong X., Fang H., Chen J., Su N., 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.
50. 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.