A live attenuated H7N3 influenza virus vaccine is well tolerated and immunogenic in a Phase I trial in healthy adults

Vaccine

Volumn 27, Issue 28, 2009, Pages 3744-3753

  Talaat, Kawsar R ^a   Karron, Ruth A ^a   Callahan, Karen A ^a   Luke, Catherine J ^b   DiLorenzo, Susan C ^a   Chen, Grace L ^b   Lamirande, Elaine W ^b   Jin, Hong ^c   Coelingh, Kathy L ^c   Murphy, Brian R ^b   Kemble, George ^c   Subbarao, Kanta ^b  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^c MEDIMMUNE   (United States)

Author keywords

Avian; H7N3 vaccine; Influenza

Indexed keywords

H7N3 VACCINE; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; INFLUENZA VACCINE; UNCLASSIFIED DRUG;

ABSCESS; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIBODY RESPONSE; ARTICLE; CLINICAL TRIAL; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; HEMAGGLUTINATION INHIBITION; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INFLUENZA; INFLUENZA VACCINATION; INFLUENZA VIRUS A; INFLUENZA VIRUS A H7N3; MALE; MYALGIA; NORMAL HUMAN; NOSE CONGESTION; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; RHINORRHEA; SIDE EFFECT; VIRUS REPLICATION; VIRUS SHEDDING; VIRUS TITRATION; VIRUS VIRULENCE; VOLUNTEER;

ADMINISTRATION, INTRANASAL; ADOLESCENT; ADULT; ANIMALS; ANTIBODIES, VIRAL; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; IMMUNIZATION, SECONDARY; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; INFLUENZA A VIRUS; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; NEUTRALIZATION TESTS; VACCINES, ATTENUATED; YOUNG ADULT;

EID: 67349237000     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.03.082     Document Type: Article

References (63)

1. Nicholson K.G., Wood J.M., and Zambon M. Influenza. Lancet 362 November (9397) (2003) 1733-1745
2. Fouchier R.A., Schneeberger P.M., Rozendaal F.W., Broekman J.M., Kemink S.A., Munster V., et al. Avian influenza A virus (H7N7) associated with human conjunctivitis and a fatal case of acute respiratory distress syndrome. Proc Natl Acad Sci USA 101 February (5) (2004) 1356-1361
3. Subbarao K., and Joseph T. Scientific barriers to developing vaccines against avian influenza viruses. Nat Rev Immunol 7 April (4) (2007) 267-278
4. DeLay P.D., Casey H.L., and Tubiash H.S. Comparative study of fowl plague virus and a virus isolated from man. Public Health Rep 82 July (7) (1967) 615-620
5. Campbell C.H., Webster R.G., and Breese Jr. S.S. Fowl plague virus from man. J Infect Dis 122 December (6) (1970) 513-516
6. Taylor H.R., and Turner A.J. A case report of fowl plague keratoconjunctivitis. Br J Ophthalmol 61 February (2) (1977) 86-88
7. Webster R.G., Geraci J., Petursson G., and Skirnisson K. Conjunctivitis in human beings caused by influenza A virus of seals. N Engl J Med 304 April (15) (1981) 911
8. Shortridge K.F. Pandemic influenza: a zoonosis?. Semin Respir Infect 7 March (1) (1992) 11-25
9. Kurtz J., Manvell R.J., and Banks J. Avian influenza virus isolated from a woman with conjunctivitis. Lancet 348 September (9031) (1996) 901-902
10. Puzelli S., Di Trani L., Fabiani C., Campitelli L., De Marco M.A., Capua I., et al. Serological analysis of serum samples from humans exposed to avian H7 influenza viruses in Italy between 1999 and 2003. J Infect Dis 192 October (8) (2005) 1318-1322
11. Koopmans M., Wilbrink B., Conyn M., Natrop G., van der Nat H., Vennema H., et al. Transmission of H7N7 avian influenza A virus to human beings during a large outbreak in commercial poultry farms in the Netherlands. Lancet 363 February (9409) (2004) 587-593
12. Tweed S.A., Skowronski D.M., David S.T., Larder A., Petric M., Lees W., et al. Human illness from avian influenza H7N3, British Columbia. Emerg Infect Dis 10 December (12) (2004) 2196-2199
13. Nguyen-Van-Tam J.S., Nair P., Acheson P., Baker A., Barker M., Bracebridge S., et al. Outbreak of low pathogenicity H7N3 avian influenza in UK, including associated case of human conjunctivitis. Euro Surveill 11 May (5) (2006) E060504 2
14. Meijer A., Bosman A., van de Kamp E.E., Wilbrink B., van Beest Holle Mdu R., and Koopmans M. Measurement of antibodies to avian influenza virus A (H7N7) in humans by hemagglutination inhibition test. J Virol Methods 132 March (1-2) (2006) 113-120
15. Myers K.P., Setterquist S.F., Capuano A.W., and Gray G.C. Infection due to 3 avian influenza subtypes in United States veterinarians. Clin Infect Dis 45 July (1) (2007) 4-9
16. Luke C.J., and Subbarao K. Vaccines for pandemic influenza. Emerg Infect Dis 12 January (1) (2006) 66-72
17. Belshe R.B., Edwards K.M., Vesikari T., Black S.V., Walker R.E., Hultquist M., et al. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med 356 February (7) (2007) 685-696
18. Fleming D.M., Crovari P., Wahn U., Klemola T., Schlesinger Y., Langussis A., et al. Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J 25 October (10) (2006) 860-869
19. Ashkenazi S., Vertruyen A., Aristegui J., Esposito S., McKeith D.D., Klemola T., et al. Superior relative efficacy of live attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. Pediatr Infect Dis J 25 October (10) (2006) 870-879
20. Nichol K.L., Mendelman P.M., Mallon K.P., Jackson L.A., Gorse G.J., Belshe R.B., et al. Effectiveness of live, attenuated intranasal influenza virus vaccine in healthy, working adults: a randomized controlled trial. JAMA 282 July (2) (1999) 137-144
21. Belshe R., Lee M.S., Walker R.E., Stoddard J., and Mendelman P.M. Safety, immunogenicity and efficacy of intranasal, live attenuated influenza vaccine. Expert Rev Vaccines 3 December (6) (2004) 643-654
22. Mendelman P.M., Rappaport R., Cho I., Block S., Gruber W., August M., et al. Live attenuated influenza vaccine induces cross-reactive antibody responses in children against an A/Fujian/411/2002-like H3N2 antigenic variant strain. Pediatr Infect Dis J 23 November (11) (2004) 1053-1055
23. Belshe R.B., Mendelman P.M., Treanor J., King J., Gruber W.C., Piedra P., et al. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine in children. N Engl J Med 338 May (20) (1998) 1405-1412
24. Chen H., Matsuoka Y., Swayne D., Chen Q., Cox N.J., Murphy B.R., et al. Generation and characterization of a cold-adapted influenza A H9N2 reassortant as a live pandemic influenza virus vaccine candidate. Vaccine 21 October (27-30) (2003) 4430-4436
25. Suguitan Jr. A.L., McAuliffe J., Mills K.L., Jin H., Duke G., Lu B., et al. Live, attenuated influenza A H5N1 candidate vaccines provide broad cross-protection in mice and ferrets. PLoS Med 3 September (9) (2006) e360
26. Joseph T., McAuliffe J., Lu B., Vogel L., Swayne D., Jin H., et al. A live attenuated cold-adapted influenza A H7N3 virus vaccine provides protection against homologous and heterologous H7 viruses in mice and ferrets. Virology 378 August (1) (2008) 123-132
27. 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 199 March (5) (2009) 711-716
28. WHO. Tables on the clinical trials of pandemic influenza prototype vaccines. 2008 3/07/2008 [cited; available from: http://www.who.int/vaccine_research/diseases/influenza/flu_trials_tables/en/index.html].
29. Maassab H.F. Adaptation and growth characteristics of influenza virus at 25 degrees C. Nature 213 February (5076) (1967) 612-614
30. Clements M.L., O Donnel S., Levine M.M., Chanock R.M., and Murphy B.R. Dose response of A/Alaska/6/77 (H3N2) cold adapted reassortant vaccine virus in adult volunteers: role of local antibody in resistance to infection with vaccine virus. Infect Immun 40 June (3) (1983) 1044-1051
31. Karron R.A., Wright P.F., Crowe Jr. J.E., Clements M.L., Thompson J., Makhene M., et al. Evaluation of two live, cold-passaged, temperature-sensitive respiratory syncytial virus vaccines in chimpanzees and in human adults, infants and children. J Infect Dis 176 December (6) (1997) 1428-1436
32. Kandun I.N., Wibisono H., Sedyaningsih E.R., Yusharmen, Hadisoedarsuno W., Purba W., et al. Three Indonesian clusters of H5N1 virus infection in 2005. N Engl J Med 355 November (21) (2006) 2186-2194
33. Murphy B.R., Tierney E.L., Barbour B.A., Yolken R.H., Alling D.W., Holley Jr. H.P., et al. Use of the enzyme-linked immunosorbent assay to detect serum antibody responses of volunteers who received attenuated influenza A virus vaccines. Infect Immun 29 August (2) (1980) 342-347
34. Stephenson I., Wood J.M., Nicholson K.G., and Zambon M.C. Sialic acid receptor specificity on erythrocytes affects detection of antibody to avian influenza haemagglutinin. J Med Virol 70 July (3) (2003) 391-398
35. Rowe T., Abernathy R.A., Hu-Primmer J., Thompson W.W., Lu X., Lim W., et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 37 April (4) (1999) 937-943
36. Sasaki S., Jaimes M.C., Holmes T.H., Dekker C.L., Mahmood K., Kemble G.W., et al. Comparison of the influenza virus-specific effector and memory B-cell responses to immunization of children and adults with live attenuated or inactivated influenza virus vaccines. J Virol 81 January (1) (2007) 215-228
37. Elkan M., Joshi S.B., Joshi Y.B., and Hodinka R.L. Real-time PCR for detection of human rhinoviruses in children. 23rd Annual Clinical Virology Symposium and Annual Meeting of Pan American Society for Clinical Virology. Clearwater, FL (2007) TP57
38. Jadhao S.J., Achenbach J., Swayne D.E., Donis R., Cox N., and Matsuoka Y. Development of Eurasian H7N7/PR8 high growth reassortant virus for clinical evaluation as an inactivated pandemic influenza vaccine. Vaccine 26 March (14) (2008) 1742-1750
39. Pappas C., Matsuoka Y., Swayne D.E., and Donis R.O. Development and evaluation of an Influenza virus subtype H7N2 vaccine candidate for pandemic preparedness. Clin Vaccine Immunol 14 November (11) (2007) 1425-1432
40. Whiteley A., Major D., Legastelois I., Campitelli L., Donatelli I., Thompson C.I., et al. Generation of candidate human influenza vaccine strains in cell culture-rehearsing the European response to an H7N1 pandemic threat. Influenza Other Respir Viruses 1 July (4) (2007) 157-166
41. de Wit E., Munster V.J., Spronken M.I., Bestebroer T.M., Baas C., Beyer W.E., et al. Protection of mice against lethal infection with highly pathogenic H7N7 influenza A virus by using a recombinant low-pathogenicity vaccine strain. J Virol 79 October (19) (2005) 12401-12407
42. Sakabe S., Sakoda Y., Haraguchi Y., Isoda N., Soda K., Takakuwa H., et al. A vaccine prepared from a non-pathogenic H7N7 virus isolated from natural reservoir conferred protective immunity against the challenge with lethal dose of highly pathogenic avian influenza virus in chickens. Vaccine 26 April (17) (2008) 2127-2134
43. Le Gall-Recule G., Cherbonnel M., Pelotte N., Blanchard P., Morin Y., and Jestin V. Importance of a prime-boost DNA/protein vaccination to protect chickens against low-pathogenic H7 avian influenza infection. Avian Dis 51 Suppl. 1 (2007) 490-494
44. Capua I., and Marangon S. The use of vaccination to combat multiple introductions of notifiable avian influenza viruses of the H5 and H7 subtypes between 2000 and 2006 in Italy. Vaccine 25 June (27) (2007) 4987-4995
45. Toro H., Tang D.C., Suarez D.L., Zhang J., and Shi Z. Protection of chickens against avian influenza with non-replicating adenovirus-vectored vaccine. Vaccine 26 May (21) (2008) 2640-2646
46. Haddy T.B., Rana S.R., and Castro O. Benign ethnic neutropenia: what is a normal absolute neutrophil count?. J Lab Clin Med 133 January (1) (1999) 15-22
47. Hsieh M.M., Everhart J.E., Byrd-Holt D.D., Tisdale J.F., and Rodgers G.P. Prevalence of neutropenia in the U.S. population: age, sex, smoking status, and ethnic differences. Ann Intern Med 146 April (7) (2007) 486-492
48. Rosenzweig P., Miget N., and Brohier S. Transaminase elevation on placebo during phase I trials: prevalence and significance. Br J Clin Pharmacol 48 July (1) (1999) 19-23
49. Purkins L., Love E.R., Eve M.D., Wooldridge C.L., Cowan C., Smart T.S., et al. The influence of diet upon liver function tests and serum lipids in healthy male volunteers resident in a phase I unit. Br J Clin Pharmacol 57 February (2) (2004) 199-208
50. Shinya K., Ebina M., Yamada S., Ono M., Kasai N., and Kawaoka Y. Avian flu: influenza virus receptors in the human airway. Nature 440 March (7083) (2006) 435-436
51. van Riel D., Munster V.J., de Wit E., Rimmelzwaan G.F., Fouchier R.A.M., Osterhaus A.D.M.E., et al. H5N1 virus attachment to lower respiratory tract. Science 312 April (5772) (2006) 399
52. Bartlett E.J., Hennessey M., Skiadopoulos M.H., Schmidt A.C., Collins P.L., Murphy B.R., et al. Role of interferon in the replication of human parainfluenza virus type 1 wild type and mutant viruses in human ciliated airway epithelium. J Virol 82 August (16) (2008) 8059-8070
53. Bateman A.C., Busch M.G., Karasin A.I., Bovin N., and Olsen C.W. Amino acid 226 in the hemagglutinin of H4N6 influenza virus determines binding affinity for alpha2,6-linked sialic acid and infectivity levels in primary swine and human respiratory epithelial cells. J Virol 82 August (16) (2008) 8204-8209
54. Murphy B.R., Richman D.D., Chalhub E.G., Uhlendorf C.P., Baron S., and Chanock R.M. Failure of attenuated temperature-sensitive influenza A (H3N2) virus to induce heterologous interference in humans to parainfluenza type 1 virus. Infect Immun 12 July (1) (1975) 62-68
55. Belser J.A., Blixt O., Chen L.M., Pappas C., Maines T.R., Van Hoeven N., et al. Contemporary North American influenza H7 viruses possess human receptor specificity: implications for virus transmissibility. Proc Natl Acad Sci USA 105 May (21) (2008) 7558-7563
56. Plotkin S.A. Vaccines: correlates of vaccine-induced immunity. Clin Infect Dis 47 August (3) (2008) 401-409
57. Eichelberger M., Golding H., Hess M., Weir J., Subbarao K., Luke C.J., et al. FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10-11, 2007. Vaccine 26 August (34) (2008) 4299-4303
58. Belshe R.B., Gruber W.C., Mendelman P.M., Mehta H.B., Mahmood K., Reisinger K., et al. Correlates of immune protection induced by live, attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine. J Infect Dis 181 March (3) (2000) 1133-1137
59. Murphy B.R., Rennels M.B., Douglas Jr. R.G., Betts R.F., Couch R.B., Cate Jr. T.R., et al. Evaluation of influenza A/Hong Kong/123/77 (H1N1) ts-1A2 and cold-adapted recombinant viruses in seronegative adult volunteers. Infect Immun 29 August (2) (1980) 348-355
60. Archetti I., and Horsfall Jr. F.L. Persistent antigenic variation of influenza A viruses after incomplete neutralization in ovo with heterologous immune serum. J Exp Med 92 November (5) (1950) 441-462
61. Karron R.A., Belshe R.B., Wright P.F., Thumar B., Burns B., Newman F., et al. A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in young infants. Pediatr Infect Dis J 22 May (5) (2003) 394-405
62. Wright P.F., Karron R.A., Belshe R.B., Thompson J., Crowe Jr. J.E., Boyce T.G., et al. Evaluation of a live, cold-passaged, temperature-sensitive, respiratory syncytial virus vaccine candidate in infancy. J Infect Dis 182 November (5) (2000) 1331-1342
63. Clements M.L., and Murphy B.R. Development and persistence of local and systemic antibody responses in adults given live attenuated or inactivated influenza A virus vaccine. J Clin Microbiol 23 January (1) (1986) 66-72