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[Evaluation of immunogenicity and safety of 2 immunizations with allantoic intranasal live influenza vaccine Ultragrivac].

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 A/chicken/Suzdalka/Nov-1 1/2005 (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).

Authors

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Pub Type(s)

Clinical Trial, Phase II
Controlled Clinical Trial
English Abstract
Journal Article

Language

rus

PubMed ID

21916043

Citation

Shishkina, L N., et al. "[Evaluation of Immunogenicity and Safety of 2 Immunizations With Allantoic Intranasal Live Influenza Vaccine Ultragrivac]." Zhurnal Mikrobiologii, Epidemiologii I Immunobiologii, 2011, pp. 92-6.
Shishkina LN, Mazurkova NA, Ternovoĭ VA, et al. [Evaluation of immunogenicity and safety of 2 immunizations with allantoic intranasal live influenza vaccine Ultragrivac]. Zh Mikrobiol Epidemiol Immunobiol. 2011.
Shishkina, L. N., Mazurkova, N. A., Ternovoĭ, V. A., Bulychev, L. E., Tumanov, I. u. V., Skarnovich, M. O., Kabanov, A. S., Ryndiuk, N. N., Kuzubov, V. I., Mironov, A. N., Stavskiĭ, E. A., & Drozdov, I. G. (2011). [Evaluation of immunogenicity and safety of 2 immunizations with allantoic intranasal live influenza vaccine Ultragrivac]. Zhurnal Mikrobiologii, Epidemiologii I Immunobiologii, (4), 92-6.
Shishkina LN, et al. [Evaluation of Immunogenicity and Safety of 2 Immunizations With Allantoic Intranasal Live Influenza Vaccine Ultragrivac]. Zh Mikrobiol Epidemiol Immunobiol. 2011 Jul-Aug;(4)92-6. PubMed PMID: 21916043.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Evaluation of immunogenicity and safety of 2 immunizations with allantoic intranasal live influenza vaccine Ultragrivac]. AU - Shishkina,L N, AU - Mazurkova,N A, AU - Ternovoĭ,V A, AU - Bulychev,L E, AU - Tumanov,Iu V, AU - Skarnovich,M O, AU - Kabanov,A S, AU - Ryndiuk,N N, AU - Kuzubov,V I, AU - Mironov,A N, AU - Stavskiĭ,E A, AU - Drozdov,I G, PY - 2011/9/15/entrez PY - 2011/9/15/pubmed PY - 2011/10/14/medline SP - 92 EP - 6 JF - Zhurnal mikrobiologii, epidemiologii i immunobiologii JO - Zh Mikrobiol Epidemiol Immunobiol IS - 4 N2 - 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 A/chicken/Suzdalka/Nov-1 1/2005 (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). SN - 0372-9311 UR - https://www.unboundmedicine.com/medline/citation/21916043/[Evaluation_of_immunogenicity_and_safety_of_2_immunizations_with_allantoic_intranasal_live_influenza_vaccine_Ultragrivac]_ L2 - https://medlineplus.gov/flu.html DB - PRIME DP - Unbound Medicine ER -