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[Results of clinical trials on reactogenicity, safety, and immunogenicity of influenza allantoic intranasal live vaccine "Ultragrivac" (type A/H5N2)].

Abstract

Results of phase II of a clinical trial of the influenza allantoic intranasal live vaccine "Ultragrivac" (type A/H5N2) are presented. The vaccine was developed based on strain /17/Duck/Potsdam/86/92 H5N2 [17/H5] - reassortant of two viruses, /Leningrad/134/17/57 (H2N2) and /Duck/Potsdam/1402-86 (H5N2), obtained from the Virology Department, St. Petersburg Institute of Experimental Medicine.Two schemes of immunization (with revaccination on days 10 and 21) were used. Evaluation of vaccine immunogenicity included determination of local, cellular and humoral immunity. A significant rise in the level of secretory IgA in the nasal cavity of vaccinated volunteers (with revaccination on days 10 and 21) was documented after application of the vaccine. The postvaccination humoral immune response was estimated from the level of significant (4-fold and more) antibody seroconversions, geometric mean titers of antibodies to two strains of influenza virus /17/Duck/Potsdam/86/92 H5N2 [17/H5] and /Chicken/Suzdalka/Nov-11/2005 (H5N1), and their incremental rate. Results of measurement of antibody titers in hemagglutination-inhibition assay are presented, with two antigens being used to analyse all serum samples from volunteers twice vaccinated with influenza vaccine "Ultragrivac" at 10 and 21 day intervals. Result of phase II of this clinical study show that influenza allantoic intranasal live vaccine "Ultragrivac" is nonreactogenic and safe for both vaccinated and surrounding individuals. Moreover, it is sufficiently immunogenic with respect not only to homologous virus A(H5N2) but also to the A(H5N1) strain.

Authors

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Pub Type(s)

Clinical Trial, Phase II
English Abstract
Journal Article

Language

rus

PubMed ID

20422755

Citation

Mazurkova, N A., et al. "[Results of Clinical Trials On Reactogenicity, Safety, and Immunogenicity of Influenza Allantoic Intranasal Live Vaccine "Ultragrivac" (type A/H5N2)]." Vestnik Rossiiskoi Akademii Meditsinskikh Nauk, 2010, pp. 15-20.
Mazurkova NA, Ryndiuk NN, Shishkina LN, et al. [Results of clinical trials on reactogenicity, safety, and immunogenicity of influenza allantoic intranasal live vaccine "Ultragrivac" (type A/H5N2)]. Vestn Ross Akad Med Nauk. 2010.
Mazurkova, N. A., Ryndiuk, N. N., Shishkina, L. N., Ternovoĭ, V. A., Tumanov, I. u. V., Bulychev, L. E., Skarnovich, M. O., Kabanov, A. S., Panchenko, S. G., Aleĭnikov, R. P., Il'ina, T. N., Kuzubov, V. I., Mel'nikov, S. I. a., Mironov, A. N., Korovkin, S. A., Sergeev, A. N., & Drozdov, I. G. (2010). [Results of clinical trials on reactogenicity, safety, and immunogenicity of influenza allantoic intranasal live vaccine "Ultragrivac" (type A/H5N2)]. Vestnik Rossiiskoi Akademii Meditsinskikh Nauk, (3), 15-20.
Mazurkova NA, et al. [Results of Clinical Trials On Reactogenicity, Safety, and Immunogenicity of Influenza Allantoic Intranasal Live Vaccine "Ultragrivac" (type A/H5N2)]. Vestn Ross Akad Med Nauk. 2010;(3)15-20. PubMed PMID: 20422755.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Results of clinical trials on reactogenicity, safety, and immunogenicity of influenza allantoic intranasal live vaccine "Ultragrivac" (type A/H5N2)]. AU - Mazurkova,N A, AU - Ryndiuk,N N, AU - Shishkina,L N, AU - Ternovoĭ,V A, AU - Tumanov,Iu V, AU - Bulychev,L E, AU - Skarnovich,M O, AU - Kabanov,A S, AU - Panchenko,S G, AU - Aleĭnikov,R P, AU - Il'ina,T N, AU - Kuzubov,V I, AU - Mel'nikov,S Ia, AU - Mironov,A N, AU - Korovkin,S A, AU - Sergeev,A N, AU - Drozdov,I G, PY - 2010/4/28/entrez PY - 2010/4/28/pubmed PY - 2010/6/23/medline SP - 15 EP - 20 JF - Vestnik Rossiiskoi akademii meditsinskikh nauk JO - Vestn Ross Akad Med Nauk IS - 3 N2 - Results of phase II of a clinical trial of the influenza allantoic intranasal live vaccine "Ultragrivac" (type A/H5N2) are presented. The vaccine was developed based on strain /17/Duck/Potsdam/86/92 H5N2 [17/H5] - reassortant of two viruses, /Leningrad/134/17/57 (H2N2) and /Duck/Potsdam/1402-86 (H5N2), obtained from the Virology Department, St. Petersburg Institute of Experimental Medicine.Two schemes of immunization (with revaccination on days 10 and 21) were used. Evaluation of vaccine immunogenicity included determination of local, cellular and humoral immunity. A significant rise in the level of secretory IgA in the nasal cavity of vaccinated volunteers (with revaccination on days 10 and 21) was documented after application of the vaccine. The postvaccination humoral immune response was estimated from the level of significant (4-fold and more) antibody seroconversions, geometric mean titers of antibodies to two strains of influenza virus /17/Duck/Potsdam/86/92 H5N2 [17/H5] and /Chicken/Suzdalka/Nov-11/2005 (H5N1), and their incremental rate. Results of measurement of antibody titers in hemagglutination-inhibition assay are presented, with two antigens being used to analyse all serum samples from volunteers twice vaccinated with influenza vaccine "Ultragrivac" at 10 and 21 day intervals. Result of phase II of this clinical study show that influenza allantoic intranasal live vaccine "Ultragrivac" is nonreactogenic and safe for both vaccinated and surrounding individuals. Moreover, it is sufficiently immunogenic with respect not only to homologous virus A(H5N2) but also to the A(H5N1) strain. SN - 0869-6047 UR - https://www.unboundmedicine.com/medline/citation/20422755/[Results_of_clinical_trials_on_reactogenicity_safety_and_immunogenicity_of_influenza_allantoic_intranasal_live_vaccine_"Ultragrivac"__type_A/H5N2_]_ L2 - https://medlineplus.gov/flushot.html DB - PRIME DP - Unbound Medicine ER -