EVALUATION OF IMMUNOGENICITY AND SAFETY OF 2 IMMUNIZATIONS WITH ALLANTOIC INTRANASAL LIVE INFLUENZA VACCINE ULTRAGRIVAC


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Abstract

Aim. Evaluate reactogenicity, safety and immunogenicity in phase 2 clinical trials of 2 immunization schedules with Ultragrivac - an allantoic intranasal life influenza vaccine based on A/17/ duck/Potsdam/86/92 [17/H5] reassortant strain. Materials and methods. 4 groups of volunteers participated in the study: group 1 - 40 individuals were vaccinated twice with a 10 day interval; group 2 - 40 individuals were vaccinated twice with a 21 day interval; group 3 (control) - 10 individuals received placebo twice with a 10 day interval; group 4 (control) - 10 individuals received placebo twice with a 21 day interval. Local (secretory IgA), cellular and humoral immune response were evaluated. Humoral immunity was evaluated by the intensity of increase of geometric mean antibody titers against 2 influenza virus strains A/17/ duck/Potsdam/86/92 [17/H5] and А/chicken/ Suzdalka/Nov-11/2005 (H5N1), and by the level of significant (4 times or more) antibody seroconversions after the vaccination. Results. After the use of Ultragrivac the level of secretory IgA in the nasal cavity of vaccinated volunteers in the groups with revaccination intervals of 10 and 21 days increased significantly. The second immunization with 10 or 21 day intervals significantly increased postvaccinal humoral immune response. Humoral immune response induction after 2 vaccinations with 10 day interval was no less effective than with 21 day interval. Conclusion. Ultragrivac allantoic intranasal live influenza vaccine is areactogenic, harmless for vaccinated individuals, safe for those around, and has immunogenic properties against not only homologous virus A(H5N2), but also against influenza strain A(H5N1).

About the authors

L. N Shishkina

State Scientific Center of Virology and Biotechnology «Vector», Russia

N. A Mazurkova

State Scientific Center of Virology and Biotechnology «Vector», Russia

V. A Ternovoy

State Scientific Center of Virology and Biotechnology «Vector», Russia

L. E Bulychev

State Scientific Center of Virology and Biotechnology «Vector», Russia

Yu. V Tumanov

State Scientific Center of Virology and Biotechnology «Vector», Russia

M. O Skarnovich

State Scientific Center of Virology and Biotechnology «Vector», Russia

A. S Kabanov

State Scientific Center of Virology and Biotechnology «Vector», Russia

N. N Ryndyuk

Medical Sanitary Unit No. 163, Koltsovo, Novosibirsk region, Russia

V. I Kuzubov

Medical Sanitary Unit No. 163, Koltsovo, Novosibirsk region, Russia

A. N Mironov

Scientific Manufacturing Corporation «Microgen», Moscow, Russia

E. A Stavsky

State Scientific Center of Virology and Biotechnology «Vector», Russia

I. G Drozdov

State Scientific Center of Virology and Biotechnology «Vector», Russia

References

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  2. Suguitan A.L., McAuliffe J., Mills K.L, et al. Live, attenuated influenza A H5N1 candidate vaccines provide broad cross-protection in mice and ferrets. PLoS Med. 2006, 3 (9): e360.
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  4. Terrence M., Renshaw M., Clemens J.D. et al. Mucosal delivery of inactivated influenza vaccine induces b-cell-dependent heterosubtypic cross-protection against lethal influenza A H5N1 virus infection. Ibid. 2001, 75 (11): 5141- 5150.

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Copyright (c) 2011 Shishkina L.N., Mazurkova N.A., Ternovoy V.A., Bulychev L.E., Tumanov Y.V., Skarnovich M.O., Kabanov A.S., Ryndyuk N.N., Kuzubov V.I., Mironov A.N., Stavsky E.A., Drozdov I.G.

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