Clinical testing of pre-pandemic live attenuated A/H5N2 influenza candidate vaccine in adult volunteers: Results from a placebo-controlled, randomized double-blind phase I study

Vaccine

Volumn 33, Issue 39, 2015, Pages 5110-5117

  Rudenko, Larisa ^a   Kiseleva, Irina ^a   Stukova, Marina ^b   Erofeeva, Marianna ^b   Naykhin, Anatoly ^a   Donina, Svetlana ^a   Larionova, Natalie ^a   Pisareva, Maria ^b   Krivitskaya, Vera ^b   Flores, Jorge ^c   Dubrovina, I Irina ^a   Isakova Sivak, Irina ^a   Petukhova, Galina ^a   Bazhenova, Ekaterina ^a   Smolonogina, Tatiana ^a   Kuznetsova, Victoria ^a   Losev, Igor ^a   Nikiforova, Alexandra ^d   Kiselev, Oleg ^b   Power, Maureen ^c   Tsvetnitsky, Vadim ^c   Tang, Yuxiao ^c   more..

^a INSTITUTE OF EXPERIMENTAL MEDICINE   (Russian Federation)

^b Research Institute of Influenza   (Russian Federation)

^c PATH   (United States)

^d Department of Preclinical Trials Microgen ^*  (Russian Federation)

Author keywords

A H5N2; Clinical trial; Immune response; Influenza; Live attenuated influenza vaccine; Pre pandemic vaccine

Indexed keywords

ALANINE AMINOTRANSFERASE; AVIAN INFLUENZA VACCINE; BICARBONATE; HEMOGLOBIN; NEUTRALIZING ANTIBODY; PLACEBO; INFLUENZA VACCINE; LIVE VACCINE; VIRUS ANTIBODY;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIBODY RESPONSE; ARTICLE; AVIAN INFLUENZA; BICARBONATE BLOOD LEVEL; BLOOD SAMPLING; CELLULAR IMMUNITY; CHILL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HEMAGGLUTINATION INHIBITION; HEMAGGLUTINATION TEST; HUMAN; IMMUNOGENICITY; INFLUENZA A VIRUS (H5N2); MALE; NOSE OBSTRUCTION; NOSE SMEAR; PERIPHERAL BLOOD MONONUCLEAR CELL; PHARYNX DISEASE; PHASE 1 CLINICAL TRIAL; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FUNCTION DISORDER; SORE THROAT; VACCINATION; VIRUS DETECTION; VIRUS SHEDDING; VIRUS TRANSMISSION; ADOLESCENT; BLOOD; CLINICAL TRIAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; IMMUNOLOGY; INFLUENZA, HUMAN; INTRANASAL DRUG ADMINISTRATION; MIDDLE AGED; MONONUCLEAR CELL; NORMAL HUMAN; PATHOLOGY; VIROLOGY; YOUNG ADULT;

ADMINISTRATION, INTRANASAL; ADOLESCENT; ADULT; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; INFLUENZA A VIRUS, H5N2 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; LEUKOCYTES, MONONUCLEAR; MALE; MIDDLE AGED; PLACEBOS; VACCINES, ATTENUATED; YOUNG ADULT;

EID: 84941748774     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.08.019     Document Type: Article

References (32)

1. Peiris M., Yen H.L. Animal and human influenzas. Rev Sci Technol 2014, 33(2):539-553.
2. Imai M., Herfst S., Sorrell E.M., Schrauwen E.J., Linster M., et al. Transmission of influenza A/H5N1 viruses in mammals. Virus Res 2013, 178:15-20.
3. Development of a clinical trial plan for pandemic influenza vaccines. National Institute of Allergy and Infectious Diseases. Meeting Summary. September 22-23, 2003. Bethesda, Maryland. Available at 〈〉 (accessed 21 September 2014). http://www.niaid.nih.gov/about/organization/dmid/Documents/pansummary.pdf.
4. Talaat K.R., Karron R.A., Liang P.H., McMahon B.A., Luke C.J., et al. An open-label Phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults. Influenza Other Respir Viruses 2013, 7:66-73.
5. Karron R.A., Talaat K., Luke C., Callahan K., Thumar B., et al. Evaluation of two live attenuated cold-adapted H5N1 influenza virus vaccines in healthy adults. Vaccine 2009, 27:4953-4960.
6. Talaat K.R., Karron R.A., Luke C.J., Thumar B., McMahon B.A., et al. An open label Phase I trial of a live attenuated H6N1 influenza virus vaccine in healthy adults. Vaccine 2011, 29:3144-3148.
7. Talaat K.R., Karron R.A., Callahan K.A., Luke C.J., DiLorenzo S.C., 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.
8. Karron R.A., Callahan K., Luke C., Thumar B., McAuliffe J., et al. A live attenuated H9N2 influenza vaccine is well tolerated and immunogenic in healthy adults. J Infect Dis 2009, 199:711-716.
9. WHO Global pandemic influenza action plan to increase vaccine supply 2006, WHO, Available at: 〈http://www.who.int/csr/resources/publications/influenza/CDS_EPR_GIP_2006_1.pdf?ua=1〉 (accessed 21 September 2014).
10. Rudenko L., Van den Bosch H., Kiseleva I., Mironov A., Naikhin A., et al. Live attenuated pandemic influenza vaccine: clinical studies on A/17/California/2009/38 (H1N1) and licensing of the Russian-developed technology to WHO for pandemic influenza preparedness in developing countries. Vaccine 2011, 29(Suppl. 1):A40-A44.
11. Desheva J.A., Rudenko L.G., Rekstin A.R., Swayne D., Cox N.J., Klimov A.I. Development of candidate H7N3 live attenuated cold-adapted influenza vaccine. Proceedings of the international conference on options for the control of influenza VI 2007, 591-592. International Medical Press, Toronto, ON, (June 17-23, 2007). J.M. Katz (Ed.).
12. Larionova N., Kiseleva I., Isakova-Sivak I., Rekstin A., Dubrovina I., et al. Live attenuated influenza vaccines against highly pathogenic H5N1 avian influenza: development and preclinical characterization. J Vaccines Vaccin 2013, 4:208. Available at: 〈http://dx.doi.org/10.4172/2157-7560.1000208〉 (accessed 21 September 2014). 10.4172/2157-7560.1000208.
13. Rudenko L., Kiseleva I., Naykhin A.N., Erofeeva N., Stukova M., et al. Assessment of human immune responses to H7 avian influenza virus of pandemic potential: results from a placebo-controlled, randomized, double-blind phase 1 study of live attenuated H7N3 influenza vaccine. PLoS Med 2014, 9:e87962.
14. Desheva J.A., Lu X.H., Rekstin A.R., Rudenko L.G., Swayne D.E., et al. Characterization of an influenza A H5N2 reassortant as a candidate for live-attenuated and inactivated vaccines against highly pathogenic H5N1 viruses with pandemic potential. Vaccine 2006, 24:6859-6866.
15. Lu X., Edwards L.E., Desheva J.A., Nguyen D.C., Rekstin A., et al. Cross-protective immunity in mice induced by live-attenuated or inactivated vaccines against highly pathogenic influenza A (H5N1) viruses. Vaccine 2006, 24:6588-6593.
16. Rudenko L., Desheva J., Korovkin S., Mironov A., Rekstin A., et al. Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials). Influenza Other Respir Viruses 2008, 2:203-209.
17. Gelfand AS, Bryzgalova SI, Melnikov SJ. A method of producing live influenza vaccine for the prevention of influenza. 2006. Patent RU 2290205 [Russian]. Available at 〈http://www.findpatent.ru/patent/229/2290205.html〉.(accessed 14 March 2015).
18. Kiseleva I.V., Voeten J.T., Teley L.C., Larionova N.V., Drieszen-van der Cruijsen S.K., et al. PB2 and PA genes control the expression of the temperature-sensitive phenotype of cold-adapted B/USSR/60/69 influenza master donor virus. J Gen Virol 2010, 91:931-937.
19. WHO Manual on animal influenza diagnosis and surveillance 2002, WHO, Available at 〈http://www.bvsde.paho.org/bvsacd/cd52/animal.pdf〉 (accessed 23 May 2014).
20. Rowe T., Abernathy R.A., Hu-Primmer J., Thompson W.W., Lu X., 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.
21. WHO Global influenza preparedness plan 2005, WHO, Available at: 〈http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_2005_5.pdf〉 (accessed 21 September 2014).
22. Talaat K., Luke C.J., Babu T., Khurana S., Manischewitz J., et al. A live attenuated H5N1 vaccine induces long-term immunity in the absence of a primary antibody response. J Infect Dis 2014, 209:1860-1869.
23. Baz M., Luke C.J., Cheng X., Jin H., Subbarao K. H5N1 vaccines in humans. Virus Res 2013, 178(1):78-98.
24. Suguitan A.L., McAuliffe J., Mills K.L., Jin H., Duke G., et al. Live, attenuated influenza A H5N1 candidate vaccines provide broad cross-protection in mice and ferrets. PLoS Med 2006, 3:e360.
25. Basha S.I., Hazenfeld S., Brady R.C., Subbramanian R.A. Comparison of antibody and T-cell responses elicited by licensed inactivated-and live-attenuated influenza vaccines against H3N2 hemagglutinin. Hum Immunol 2011, 72:463-469.
26. Hoft D.F., Babusis E., Worku S., Spencer C.T., Lottenbach K., et al. Live and inactivated influenza vaccines induce similar humoral responses, but only live vaccines induce diverse T-cell responses in young children. J Infect Dis 2011, 204:845-853.
27. Barria M.I., Garrido J.L., Stein C., Scher E., Yongchao E., et al. Localized mucosal response to intranasal live attenuated influenza vaccine in adults. J Infect Dis 2013, 207:115-124.
28. Gustin K.M., Maines T.R., Belser J.A., van Hoeven N., Lu X., et al. Comparative immunogenicity and cross-clade protective efficacy of mammalian cell-grown inactivated and live attenuated H5N1 reassortant vaccines in ferrets. J Infect Dis 2011, 204:1491-1499.
29. Rudenko L., Isakova-Sivak I., Donina S. H7N3 live attenuated influenza vaccine has a potential to protect against new H7N9 avian influenza virus. Vaccine 2013, 31(42):4702-4705.
30. Isakova-Sivak I., Chen L-M., Bourgeois M., Matsuoka Y., Voeten J.T., et al. Characterization of reverse genetics-derived cold-adapted master donor virus A/Leningrad/134/17/57 (H2N2) and reassortants with H5N1 surface genes in a mouse model. Clin Vaccine Immunol 2014, 21(5):722-731.
31. Grigorieva E., Drinevskii V., Doroshenko E., Desheva J., Erofeeva M., et al. Efficacy of live attenuated cold-adapted influenza vaccine during the circulation of drift influenza viruses. Epidemiol Vaccinal Prev 2009, 1:45-53. [Russian].
32. Sridhar S., Begom S., Bermingham A., Hoschler K., Adamson W., et al. Celluar immune correlates of protection against symptomatic pandemic influenza. Nat Med 2013, 10:1305-1312.