Assessment of human immune responses to H7 avian influenza virus of pandemic potential: Results from a placebo-controlled, randomized double-blind phase I study of live attenuated H7N3 influenza vaccine

PLoS ONE

Volumn 9, Issue 2, 2014, Pages

  Rudenko, Larisa ^a   Kiseleva, Irina ^a   Naykhin, Anatoly N ^a   Erofeeva, Marianna ^b   Stukova, Marina ^b   Donina, Svetlana ^a   Petukhova, Galina ^a   Pisareva, Maria ^b   Krivitskaya, Vera ^b   Grudinin, Michael ^b   Buzitskaya, Zhanna ^b   Isakova Sivak, Irina ^a   Kuznetsova, Svetlana ^a   Larionova, Natalie ^a   Desheva, Julia ^a   Dubrovina, Irina ^a   Nikiforova, Alexandra ^c   Victor, John C ^d   Neuzil, Kathy ^d   Flores, Jorge ^d   Tsvetnitsky, Vadim ^d   Kiselev, Oleg ^b   more..

^a INSTITUTE OF EXPERIMENTAL MEDICINE   (Russian Federation)

^b Institute of Influenza   (Russian Federation)

^c Department of Molecular Virology Institute of Influenza ^*  (Russian Federation)

^d Program for Appropriate Technology in Health   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; INFLUENZA VACCINE; PLACEBO; VIRUS RNA; LIVE VACCINE; VIRUS ANTIBODY;

ADULT; ANTIBODY PRODUCTION; ARTICLE; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CONTROLLED STUDY; CROSS REACTION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEMAGGLUTINATION INHIBITION TEST; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; IMMUNOGENICITY; INFECTION PREVENTION; INFLUENZA A; INFLUENZA VACCINATION; INFLUENZA VIRUS A H7N3; MALE; MEMORY T LYMPHOCYTE; NONHUMAN; NORMAL HUMAN; NOSE SMEAR; PANDEMIC; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; VIRUS ISOLATION; VIRUS SHEDDING; ADOLESCENT; BLOOD; CLINICAL TRIAL; COLD; IMMUNOLOGY; INFLUENZA VIRUS A H7N9; INFLUENZA, HUMAN; MIDDLE AGED; SERODIAGNOSIS; VIRUS REPLICATION; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, VIRAL; CD4-POSITIVE T-LYMPHOCYTES; CD8-POSITIVE T-LYMPHOCYTES; COLD TEMPERATURE; FEMALE; HUMANS; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; INFLUENZA A VIRUS, H7N3 SUBTYPE; INFLUENZA A VIRUS, H7N9 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; NEUTRALIZATION TESTS; VACCINES, ATTENUATED; VIRUS REPLICATION; YOUNG ADULT;

EID: 84895735598     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0087962     Document Type: Article

References (25)

1. Rudenko L, Desheva J, Korovkin S, Mironov A, Rekstin A et al. (2008) Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials). Influenza Other Respi Viruses 2(6): 203-209.
2. Desheva JA, Rudenko LG, Rekstin AR, Swayne D, Cox NJ et al. (2007) Development of candidate H7N3 live attenuated cold-adapted influenza vaccine. In: Proceedings of the International Conference on Options for the Control of Influenza VI, Toronto, Ontario, Canada, June 17-23, 2007 (Ed. Jacqueline M . Katz). International Medical Press. 591-592.
3. Alexandrova GI (1977) Use of the genetic recombination method for obtaining vaccinal strains of the influenza virus [Article in Russian]. Vopr Virusol 4: 387-395.
4. WHO Manual on animal influenza diagnosis and surveillance (2002) Available: http://www.bvsde.paho.org/bvsacd/cd52/animal.pdf. Accessed 2013 Aug 12.
5. Kiseleva I, Larionova N, Kuznetsov V, Rudenko L (2010) Phenotypic characteristics of novel swine-origin influenza A/California/07/2009 (H1N1) virus. Influenza Other Respi Viruses 4(1): 1-5.
6. Reed LJ, Muench H (1938) A simple method of estimating fifty per cent endpoints. Amer J Hygiene 27(3): 493-497.
7. Hoffmann E, Stech J, Guan Y, Webster RG, Perez DR (2001) Universal primer set for the full-length amplification of all influenza A viruses. Arch Virol 146(12): 2275-2289. (Pubitemid 34682391)
8. Naikhin AN, Donina SA, Kustikova IuG, Katorgina LG, Rudenko LG (1997) Monoclonal immunoenzyme test-system for evaluating secretory immunity to influenza A and B viruses [Article in Russian]. Vopr Virusol 42: 212-216. (Pubitemid 127519784)
9. Prussin C, Metcalfe DD (1995) Detection of intracytoplasmic cytokine using flow cytometry and directly conjugated anti-cytokine antibodies. J Immunol Methods 188(1): 117-128. (Pubitemid 26011539)
10. He XS, Holmes TH, Zhang C, Mahmood K, Kemble GW et al. (2006) Cellular immune responses in children and adults receiving inactivated or live attenuated influenza vaccines. J Virol 80(23): 11756-117566.
11. Meijer A, Bosman A, van de Kamp EE, Wilbrink B, van Beest Holle Mdu R et al. (2006) Measurement of antibodies to avian influenza virus A(H7N7) in humans by hemagglutination inhibition test. J Virol Methods 132(1-2): 113-120. (Pubitemid 43220169)
12. Talaat KR, Karron RA, Callahan KA, Luke CJ, DiLorenzo SC et al. (2009) A live attenuated H7N3 influenza virus vaccine is well-tolerated and immunogenic in a phase I trial in healthy adults. Vaccine 27(28): 3744-3753.
13. Metreveli G, Zohari S, Ejdersund A, Berg M (2010) Phylogenetic analysis of the hemagglutinin gene of low pathogenic avian influenza virus H7N7 strains in mallards in northern Europe. Avian Dis 54(1 Suppl): 453-456.
14. Joseph T, McAuliffe J, Lu B, Jin H, Kemble G et al. (2007) Evaluation of replication and pathogenicity of avian influenza A H7 subtype viruses in a mouse model. J Virol 81(19): 10558-10566. (Pubitemid 47463329)
15. Fouchier RA, Schneeberger PM, Rozendaal FW, Broekman JM, Kemink SA et al. (2004) Avian influenza A virus (H7N7) associated with human conjunctivitis and a fatal case of acute respiratory distress syndrome. Proc Natl Acad Sci USA 101(5): 1356-1361. (Pubitemid 38182693)
16. Mallory RM, Malkin E, Ambrose CS, Bellamy T, Shi L et al. (2010) Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two randomized controlled trials. PLoS One 5(10): e13755. doi: 10.1371/journal.pone.0013755.
17. Requirements for influenza vaccine (inactivated) and for influenza vaccines (live) (1979) WHO Expert Committee on Biological Standardization. Thirtieth report, Annex 3. Geneva, World Health Organization (WHO Technical Report Series, No. 638). Available: http://www.who.int/biologicals/publications/ trs/areas/vaccines/influenza/WHO-TRS-638-InfluenzaA3.pdf. Accessed 2013 Aug 12.
18. Points to consider on the development of live attenuated influenza vaccines (EMEA/CPMP/BWP/2289/01) (2003) Available: http://www.tga.gov.au/pdf/ euguide/bwp228901en.pdf. Accessed 2013 Aug 12.
19. WHO recommendations to assure the quality, safety, and efficacy of influenza vaccines (human, live attenuated) for intranasal administration (2009) Final Expert Committee on Biological Standardization. Available: http://www.who.int/biologicals/areas/vaccines/influenza/Influenza-vaccines- final-14MAY-2010.pdf. Accessed 2013 Aug 12.
20. Petukhova G, Korenkov D, Chirkova T, Donina S, Rudenko L et al. (2012) B- and T-cell memory elicited by a seasonal live attenuated reassortant influenza vaccine: assessment of local antibody avidity and virus-specific memory T-cells using trogocytosis-based method. Influenza Other Respi Viruses 6(2): 119-126.
21. Rudenko L, Bosch H, Kiseleva I, Mironov A, Naikhin A et al. (2011) Live attenuated pandemic influenza vaccine: clinical studies on A/17/California/2009/ 38 (H1N1) and licensing of the Russian2developed technology to WHO for pandemic influenza preparedness in developing countries. Vaccine 29(1 Suppl): A40-A44.
22. Chirkova TV, Naykhin AN, Petukhova GD, Korenkov DA, Donina SA et al. (2011)Memory T-cell immune response in healthy young adults vaccinated with live attenuated influenza A (H5N2) vaccine. Clin Vaccine Immunol 18(10): 1710-1718.
23. Rudenko L, Isakova-Sivak I, Donina S (2013) H7N3 live attenuated influenza vaccine has a potential to protect against new H7N9 avian influenza virus. Vaccine 31(42): 4702-4705.
24. Metreveli G, Zohari S, Ejdersund A, Berg M (2010) Phylogenetic analysis of the hemagglutinin gene of low pathogenic avian influenza virus H7N7 strains in mallards in northern Europe. Avian Dis 54(1 Suppl):453-456.
25. Kageyama T, Fujisaki S, Takashita E, Xu H, Yamada S et al. (2013) Genetic analysis of novel avian A(H7N9) influenza viruses isolated from patients in China, February to April 2013. Euro Surveill 18(15):pii = 20453. Available: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId =20453. Accessed 2013 Aug 12.