Evaluation of two live attenuated cold-adapted H5N1 influenza virus vaccines in healthy adults

Vaccine

Volumn 27, Issue 36, 2009, Pages 4953-4960

  Karron, Ruth A ^a   Talaat, Kawsar ^a   Luke, Catherine ^b   Callahan, Karen ^a   Thumar, Bhagvanji ^a   DiLorenzo, Susan ^a   McAuliffe, Josephine ^b   Schappell, Elizabeth ^a   Suguitan, Amorsolo ^b   Mills, Kimberly ^b   Chen, Grace ^b   Lamirande, Elaine ^b   Coelingh, Kathleen ^c   Jin, Hong ^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

Clinical trial; H5N1; Influenza; Pandemic; Vaccine

Indexed keywords

ALANINE AMINOTRANSFERASE; GENE PRODUCT; H5N1 HK 2003 AA COLD ADAPTED VACCINE; H5N1 VN 2004 AA COLD ADAPTED VACCINE; HEMAGGLUTINATION INHIBITING ANTIBODY; IMMUNOGLOBULIN A ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; INFLUENZA VACCINE; LIVE VACCINE; NEUTRALIZING ANTIBODY; UNCLASSIFIED DRUG; VIRUS HEMAGGLUTININ; VIRUS SIALIDASE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANIMAL CELL; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CHILL; CLINICAL TRIAL; COUGHING; DIARRHEA; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG MEGADOSE; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HEADACHE; HEARTBURN; HEAT RASH; HEMAGGLUTINATION INHIBITION; HUMAN; HUMAN EXPERIMENT; HUMAN TISSUE; IMMUNE RESPONSE; IMMUNOGENICITY; INFLUENZA VIRUS A H5N1; KNEE PAIN; LOW DRUG DOSE; MALE; NONHUMAN; NORMAL HUMAN; PHARYNGITIS; PRIORITY JOURNAL; REAL TIME POLYMERASE CHAIN REACTION; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; RHINORRHEA; SIDE EFFECT; THROAT CULTURE; THROMBOCYTE COUNT; TINEA CORPORIS; TOOTH ABSCESS; TOOTH PAIN; VIRUS CULTURE; VIRUS INFECTIVITY; VIRUS SHEDDING; WHEEZING;

ADOLESCENT; ADULT; ANTIBODIES, VIRAL; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; IMMUNIZATION, SECONDARY; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; INFLUENZA A VIRUS, H5N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; NASAL MUCOSA; NEUTRALIZATION TESTS; VACCINES, ATTENUATED; YOUNG ADULT;

EID: 67650470885     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.05.099     Document Type: Article

References (40)

1. Treanor J.J., Campbell J.D., Zangwill K.M., Rowe T., and Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 354 March (13) (2006) 1343-1351
2. Treanor J.J., Wilkinson B.E., Masseoud F., Hu-Primmer J., Battaglia R., O'Brien D., et al. Safety and immunogenicity of a recombinant hemagglutinin vaccine for H5 influenza in humans. Vaccine 19 February (13-14) (2001) 1732-1737
3. 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 367 May (9523) (2006) 1657-1664
4. Nicholson K.G., Colegate A.E., Podda A., Stephenson I., Wood J., Ypma E., et al. Safety and antigenicity of non-adjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a randomised trial of two potential vaccines against H5N1 influenza. Lancet 357 June (9272) (2001) 1937-1943
5. Stephenson I., Das R.G., Wood J.M., and Katz J.M. Comparison of neutralising antibody assays for detection of antibody to influenza A/H3N2 viruses: an international collaborative study. Vaccine 25 May (20) (2007) 4056-4063
6. Stephenson I., Bugarini R., Nicholson K.G., Podda A., Wood J.M., Zambon M.C., et al. Cross-reactivity to highly pathogenic avian influenza H5N1 viruses after vaccination with nonadjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a potential priming strategy. J Infect Dis 191 April (8) (2005) 1210-1215
7. 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 370 August (9587) (2007) 580-589
8. Keitel W.A., and Atmar R.L. Preparing for a possible pandemic: influenza A/H5N1 vaccine development. Curr Opin Pharmacol 7 October (5) (2007) 484-490
9. Ehrlich H.J., Muller 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 358 June (24) (2008) 2573-2584
10. Levie K., Leroux-Roels I., Hoppenbrouwers K., Kervyn A.D., Vandermeulen C., Forgus S., et al. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis 198 September (5) (2008) 642-649
11. Nolan T., Richmond P.C., Formica N.T., Hoschler K., Skeljo M.V., Stoney T., et al. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine 26 November (50) (2008) 6383-6391
12. Nolan T.M., Richmond P.C., Skeljo M.V., Pearce G., Hartel G., Formica N.T., et al. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine 26 August (33) (2008) 4160-4167
13. Bernstein D.I., Edwards K.M., Dekker C.L., Belshe R., Talbot H.K., Graham I.L., et al. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis 197 March (5) (2008) 667-675
14. Fazekas G., Martosne-Mendi R., Jankovics I., Szilvasy I., and Vajo Z. Cross-reactive immunity in adult and elderly patients against clade 2 influenza A H5N1 virus strains induced by Fluval, a reverse genetic-derived adjuvanted H5N1 clade 1 prototype pandemic influenza vaccine. Clin Vaccine Immunol November (19) (2008) 19
15. Vajo Z., Kosa L., Szilvasy I., Pauliny Z., Bartha K., Visontay I., et al. Safety and immunogenicity of a prepandemic influenza A (H5N1) vaccine in children. Pediatr Infect Dis J 27 December (12) (2008) 1052-1056
16. 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
17. Belshe R.B., Gruber W.C., Mendelman P.M., Cho I., Reisinger K., Block S.L., et al. Efficacy of vaccination with live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine against a variant (A/Sydney) not contained in the vaccine. J Pediatr 136 (2000) 168-175
18. Halloran M.E., Piedra P.A., Longini Jr. I.M., Gaglani M.J., Schmotzer B., Fewlass C., et al. Efficacy of trivalent, cold-adapted, influenza virus vaccine against influenza A (Fujian), a drift variant, during 2003-2004. Vaccine 25 May (20) (2007) 4038-4045
19. Tam J.S., Capeding M.R., Lum L.C., Chotpitayasunondh T., Jiang Z., Huang L.M., et al. Efficacy and safety of a live attenuated, cold-adapted influenza vaccine, trivalent against culture-confirmed influenza in young children in Asia. Pediatr Infect Dis J 26 July (7) (2007) 619-628
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. 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
22. 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
23. 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
24. 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 June (2008)
25. Karron R., 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 Mar (5) (2009) 711-716
26. 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 358 January (3) (2008) 261-273
27. Stephenson I., Wood J.M., Nicholson K.G., Charlett A., and 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 103 July (1-2) (2004) 91-95
28. 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 (1983) 1044
29. 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
30. Kashyap A.K., Steel J., Oner A.F., Dillon M.A., Swale R.E., Wall K.M., et al. Combinatorial antibody libraries from survivors of the Turkish H5N1 avian influenza outbreak reveal virus neutralization strategies. Proc Natl Acad Sci U S A 105 April (16) (2008) 5986-5991
31. Shinya K., Ebina M., Yamada S., Ono M., Kasai N., and Kawaoka Y. Avian flu: Influenza virus receptors in the human airway. Nature 440 7083 (2006) 435-436
32. Powers D.C., Kilbourne E.D., and Johansson B.E. Neuraminidase-specific antibody responses to inactivated influenza virus vaccine in young and elderly adults. Clin Diagn Lab Immunol 3 September (5) (1996) 511-516
33. Gillim-Ross L., and Subbarao K. Can immunity induced by the human influenza virus N1 neuraminidase provide some protection from avian influenza H5N1 viruses?. PLoS Med 4 February (2) (2007) e91
34. Kilbourne E.D., Laver W.G., Schulman J.L., and Webster R.G. Antiviral activity of antiserum specific for an influenza virus neuraminidase. J Virol 2 April (4) (1968) 281-288
35. Murphy B.R., Kasel J.A., and Chanock R.M. Association of serum anti-neuraminidase antibody with resistance to influenza in man. N Engl J Med 286 (1972) 1329
36. Sandbulte M.R., Jimenez G.S., Boon A.C., Smith L.R., Treanor J.J., and Webby R.J. Cross-reactive neuraminidase antibodies afford partial protection against H5N1 in mice and are present in unexposed humans. PLoS Med 4 February (2) (2007) e59
37. Maines T.R., Chen L.M., Matsuoka Y., Chen H., Rowe T., Ortin J., et al. Lack of transmission of H5N1 avian-human reassortant influenza viruses in a ferret model. Proc Natl Acad Sci U S A 103 August (32) (2006) 12121-12126
38. 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
39. 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 5 (2000) 1331-1342
40. 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 27 June (28) (2009) 3744-3753