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

Volumn 29, Issue SUPPL. 1, 2011, Pages

  Rudenko, Larisa ^a,b   van den Bosch, Han ^c   Kiseleva, Irina ^a,b   Mironov, Alexander ^d   Naikhin, Anatoly ^a   Larionova, Natalie ^a   Bushmenkov, Dimitry ^d  

^a INSTITUTE OF EXPERIMENTAL MEDICINE   (Russian Federation)

^b BioDiem Ltd   (Australia)

^c Nobilon International BV   (Netherlands)

^d Microgen Federal State Company   (Russian Federation)

Author keywords

Clinical; Live attenuated influenza vaccine; Pandemic; Technology transfer; WHO

Indexed keywords

INFLUENZA VACCINE; LIVE ATTENUATED INFLUENZA VIRUS VACCINE; PLACEBO; UNCLASSIFIED DRUG;

2009 H1N1 INFLUENZA; ADULT; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG APPROVAL; DRUG INDUSTRY; DRUG SAFETY; DRUG SYNTHESIS; EGG; FEMALE; HUMAN; HUMAN CELL; IMMUNOGENICITY; INFLUENZA VACCINATION; INFLUENZA VIRUS A H1N1; INFLUENZA VIRUS A H2N2; LICENSING; MALE; MEDICAL TECHNOLOGY; MOUSE; NONHUMAN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RUSSIAN FEDERATION; UNITED STATES; UNSPECIFIED SIDE EFFECT; WORLD HEALTH ORGANIZATION;

DEVELOPING COUNTRIES; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; LICENSURE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RUSSIA; TECHNOLOGY TRANSFER; TECHNOLOGY, PHARMACEUTICAL; VACCINES, ATTENUATED; WORLD HEALTH ORGANIZATION;

EID: 79959270489     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.04.122     Document Type: Article

References (14)

1. Nobilon initiates proof of concept trial for SCH900795, a new intranasal influenza vaccine for annual seasonal use. Available form: Pharmaceutical-Business-Review.com; 2009.
2. Global pandemic influenza action plan to increase vaccine supply 2006, World Health Organization, WHO/IVB/06.13.
3. Hickling J, D'Hondt E. Review of production technologies for influenza virus vaccines and their suitability in developing countries for influenza pandemic preparedness. Available from: [accessed 25.11.10]. http://www.who.int/entity/vaccine_research/diseases/influenza/Flu_vacc_manuf_tech_report.pdf.
4. World Health Organization. Options for Live Attenuated Influenza Vaccines (LAIV) in the control of epidemic and pandemic influenza. Geneva. Available from: ; 2007 [accessed 09.11.10]. http://www.who.int/vaccine_research/diseases/influenza/meeting_120707/en/index.html.
5. Davenport F.M., Hennessy A.V., Maassab H.F., Minuse E., Clark L.C., Abrams G.D., et al. Pilot studies on recombinant cold-adapted live type A and B influenza virus vaccines. J Infect Dis 1977, 136:17-25.
6. Kendal A.P., Maassab H.F., Alexandrova G.I., Ghendon Y.Z. Development of cold-adapted recombinant live, attenuated influenza vaccines in USA and USSR. Antiviral Res 1981, 1:339-365.
7. Kendal A.P. Cold-adapted live attenuated influenza vaccines developed in Russia: can they contribute to meeting the needs for influenza control in other countries?. Eur J Epidemiol 1997, 13:591-609.
8. Rudenko L.G., Lonskaya N.I., Klimov A.I., Vasilieva R.I., Ramirez A. Clinical and epidemiological evaluation of a live, cold-adapted influenza vaccine for 3-14-year-olds. Bull World Health Organ 1996, 74:77-84.
9. Requirements for influenza vaccine (inactivated) and for influenza vaccines (live). WHO Expert Committee on Biological Standardization. Thirtieth report. Annex 3 1979, World Health Organization, Geneva, [WHO Technical Report Series, No. 638].
10. Points to consider on the development of live attenuated influenza vaccines (CPMP). EMEA. Available from: ; 2003 [accessed 06.06.10]. http://www.ema.europa.eu/pdfs/human/bwp/228901en.pdf.
11. Petukhova G., Naikhin A., Chirkova T., Donina S., Korenkov D., Rudenko L. Comparative studies of local antibody and cellular immune responses to influenza infection and vaccination with live attenuated reassortant influenza vaccine (LAIV) utilizing a mouse nasal-associated lymphoid tissue (NALT) separation method. Vaccine 2009, 27:2580-2587.
12. He X.S., Holmes T.H., Zhang C., Mahmood K., Kemble G.W., Lewis D.B., et al. Cellular immune responses in children and adults receiving inactivated or live attenuated influenza vaccines. J Virol 2006, 80:11756-11766.
13. Tamura S., Tanimoto T., Kurata T. Mechanisms of broad cross-protection provided by influenza virus infection and their application to vaccines. Jpn J Infect Dis 2005, 58:195-207.
14. Rudenko L.G., Arden N.H., Grigorieva E., Naychin A., Rekstin A., Klimov A.I., et al. Immunogenicity and efficacy of Russian live attenuated influenza vaccines used alone and in combination in nursing home residents. Vaccine 2001, 19:308-318.