CLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU

Abstract. Evaluation of reactogenicity, safety and immunogenicity of the inactivated subunit influenza vaccine adsorbed monovalent (Pandeflu) on the base of strain A/California/7/2009 (H1N1v) was conducted in 70 volunteers aged 18–60 years immunized by one or two doses. A clinical trial of the vacci...

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Autores principales: M. K. Erofeeva, V. L. Maksakova, I. Y. Nickonorov, M. G. Pozdnyakova, O. S. Kotova, E. A. Okhapkina, V. D. Evgrafov, E. M. Voicehovskaya, A. A. Vasilyeva, M. A. Stukova, D. S. Bushmenkov, A. A. Romanova, O. I. Kiselev
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Publicado: Sankt-Peterburg : NIIÈM imeni Pastera 2014
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Acceso en línea:https://doaj.org/article/c2a2b5bb3d9c497b9eba6028679e79ee
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spelling oai:doaj.org-article:c2a2b5bb3d9c497b9eba6028679e79ee2021-11-22T07:09:45ZCLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU2220-76192313-739810.15789/2220-7619-2011-4-349-354https://doaj.org/article/c2a2b5bb3d9c497b9eba6028679e79ee2014-07-01T00:00:00Zhttps://www.iimmun.ru/iimm/article/view/68https://doaj.org/toc/2220-7619https://doaj.org/toc/2313-7398Abstract. Evaluation of reactogenicity, safety and immunogenicity of the inactivated subunit influenza vaccine adsorbed monovalent (Pandeflu) on the base of strain A/California/7/2009 (H1N1v) was conducted in 70 volunteers aged 18–60 years immunized by one or two doses. A clinical trial of the vaccine Pandeflu was conducted in the St.Petersburg Institute of Influenza. The study group included 38 women (54,3%) and 32 men (45,7%). The average age of women was 38.2 years, men — 26.9 years, mean age of all volunteers was equal to 31.7 years. This group of volunteers was randomized in 2 subgroups. The first subgroup of 50 volunteers was vaccinated with Pandeflu, but the second one of 20 volunteers was given a placebo. The strong and moderate local and systemic reactions were not observed. All local (6 volunteers) and systemic (6 volunteers) reactions were recorded after ithout any medical care. It proves the good tolerability and low reactogenicity of vaccine Pandeflu. Indicators of clinical and biochemical blood tests, a general analysis of urine during the study period were within normal limits. In the study of the immunogenicity it has been shown that after a single injection of vaccine the first vaccination. All these reactions were mild and transient and disappeared wPandeflu the seroconversion rate reached 68%, but the level of seroprotection was 52%. The multiplication factor of the geometric mean antibody titer increase in serum reached a value of 5.8. Conducting of immunization with two doses of vaccine with the interval of 28 days increases the immunogenicity: the level of seroconversion rate increases up to 96%, but the level of seroprotection – up to 74%, seroconversion factor – up to 10.8. These data confirm high immunogenic potential vaccine in case of single dose as well as double doses administration.M. K. ErofeevaV. L. MaksakovaI. Y. NickonorovM. G. PozdnyakovaO. S. KotovaE. A. OkhapkinaV. D. EvgrafovE. M. VoicehovskayaA. A. VasilyevaM. A. StukovaD. S. BushmenkovA. A. RomanovaO. I. KiselevSankt-Peterburg : NIIÈM imeni Pasteraarticleclinical trialspandemiainfluenzavaccinepandefluInfectious and parasitic diseasesRC109-216RUInfekciâ i Immunitet, Vol 1, Iss 4, Pp 349-354 (2014)
institution DOAJ
collection DOAJ
language RU
topic clinical trials
pandemia
influenza
vaccine
pandeflu
Infectious and parasitic diseases
RC109-216
spellingShingle clinical trials
pandemia
influenza
vaccine
pandeflu
Infectious and parasitic diseases
RC109-216
M. K. Erofeeva
V. L. Maksakova
I. Y. Nickonorov
M. G. Pozdnyakova
O. S. Kotova
E. A. Okhapkina
V. D. Evgrafov
E. M. Voicehovskaya
A. A. Vasilyeva
M. A. Stukova
D. S. Bushmenkov
A. A. Romanova
O. I. Kiselev
CLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU
description Abstract. Evaluation of reactogenicity, safety and immunogenicity of the inactivated subunit influenza vaccine adsorbed monovalent (Pandeflu) on the base of strain A/California/7/2009 (H1N1v) was conducted in 70 volunteers aged 18–60 years immunized by one or two doses. A clinical trial of the vaccine Pandeflu was conducted in the St.Petersburg Institute of Influenza. The study group included 38 women (54,3%) and 32 men (45,7%). The average age of women was 38.2 years, men — 26.9 years, mean age of all volunteers was equal to 31.7 years. This group of volunteers was randomized in 2 subgroups. The first subgroup of 50 volunteers was vaccinated with Pandeflu, but the second one of 20 volunteers was given a placebo. The strong and moderate local and systemic reactions were not observed. All local (6 volunteers) and systemic (6 volunteers) reactions were recorded after ithout any medical care. It proves the good tolerability and low reactogenicity of vaccine Pandeflu. Indicators of clinical and biochemical blood tests, a general analysis of urine during the study period were within normal limits. In the study of the immunogenicity it has been shown that after a single injection of vaccine the first vaccination. All these reactions were mild and transient and disappeared wPandeflu the seroconversion rate reached 68%, but the level of seroprotection was 52%. The multiplication factor of the geometric mean antibody titer increase in serum reached a value of 5.8. Conducting of immunization with two doses of vaccine with the interval of 28 days increases the immunogenicity: the level of seroconversion rate increases up to 96%, but the level of seroprotection – up to 74%, seroconversion factor – up to 10.8. These data confirm high immunogenic potential vaccine in case of single dose as well as double doses administration.
format article
author M. K. Erofeeva
V. L. Maksakova
I. Y. Nickonorov
M. G. Pozdnyakova
O. S. Kotova
E. A. Okhapkina
V. D. Evgrafov
E. M. Voicehovskaya
A. A. Vasilyeva
M. A. Stukova
D. S. Bushmenkov
A. A. Romanova
O. I. Kiselev
author_facet M. K. Erofeeva
V. L. Maksakova
I. Y. Nickonorov
M. G. Pozdnyakova
O. S. Kotova
E. A. Okhapkina
V. D. Evgrafov
E. M. Voicehovskaya
A. A. Vasilyeva
M. A. Stukova
D. S. Bushmenkov
A. A. Romanova
O. I. Kiselev
author_sort M. K. Erofeeva
title CLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU
title_short CLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU
title_full CLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU
title_fullStr CLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU
title_full_unstemmed CLINICAL TRIAL OF THE PANDEMIC INFLUENZA MONOVALENT VACCINE PANDEFLU
title_sort clinical trial of the pandemic influenza monovalent vaccine pandeflu
publisher Sankt-Peterburg : NIIÈM imeni Pastera
publishDate 2014
url https://doaj.org/article/c2a2b5bb3d9c497b9eba6028679e79ee
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