Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon model

Introduction. The Gamaleya National Center of Epidemiology and Microbiology has developed a live intranasal pertussis vaccine, GamLVP, for protection against whooping cough. It is indicated for vaccination of infants and revaccination of adults of all age groups. Preclinical studies on suckling mice...

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Main Authors: A. A. Djidaryan, A. Z. Matua, A. Yu. Medkova, E. G. Semin, L. N. Sinyashina, I. N. Dyakov, I. N. Chernyshova, D. T. Kubrava, A. A. Amichba, I. G. Kondzariya, Z. Ya. Mikvabiya, G. I. Karataev
Format: Article
Language:Russian
Published: Central Research Institute for Epidemiology 2022-05-01
Series:Журнал микробиологии, эпидемиологии и иммунобиологии
Subjects:
Online Access:https://microbiol.elpub.ru/jour/article/view/1218
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author A. A. Djidaryan
A. Z. Matua
A. Yu. Medkova
E. G. Semin
L. N. Sinyashina
I. N. Dyakov
I. N. Chernyshova
D. T. Kubrava
A. A. Amichba
I. G. Kondzariya
Z. Ya. Mikvabiya
G. I. Karataev
author_facet A. A. Djidaryan
A. Z. Matua
A. Yu. Medkova
E. G. Semin
L. N. Sinyashina
I. N. Dyakov
I. N. Chernyshova
D. T. Kubrava
A. A. Amichba
I. G. Kondzariya
Z. Ya. Mikvabiya
G. I. Karataev
author_sort A. A. Djidaryan
collection DOAJ
description Introduction. The Gamaleya National Center of Epidemiology and Microbiology has developed a live intranasal pertussis vaccine, GamLVP, for protection against whooping cough. It is indicated for vaccination of infants and revaccination of adults of all age groups. Preclinical studies on suckling mice or rats and adult monkeys as well as clinical trials involving adult volunteers demonstrated safety and efficacy of the GamLVP vaccine. The expansion of the GamLVP vaccine to be used for vaccination of infants requires additional preclinical studies to assess its safety and immunogenicity in the most suitable experimental model of infant hamadryas baboons (Papio hamadryas).The aim of the study was to assess safety and immunogenicity of the GamLVP vaccine administered intranasally for a single dose, two-dose, and three-dose immunization of P. hamadryas infants.Materials and methods. The study was performed in three 1–2-month-old P. hamadryas infants kept, together with their mothers, in a separate cage. The results of the complete blood count and biochemical profile tests were measured before and after the immunization and experimental infection. The enzyme immunoassay (EIA) was used to detect any changes in the levels of specific IgG antibodies in sera from the mothers and infants; the agglutination test (AT) was used to measure titers of total anti-pertussis antibodies.Results. The intranasal immunization of P. hamadryas infants with the GamLVP vaccine triggered development of a specific humoral immune response mediated by IgG antibodies (pertussis toxin + filamentous hemagglutinin), increased titers of total agglutinating anti-pertussis antibodies, caused no local and systemic reactions, caused no changes in the complete blood count and biochemical profile. The experimental infection of the GamLVPimmunized P. hamadryas infants did not cause any changes in the laboratory blood test values and any clinical manifestations typical of the pertussis infection.
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spelling doaj.art-d090f35323d34678864b5e82237fdb392022-12-22T03:06:10ZrusCentral Research Institute for EpidemiologyЖурнал микробиологии, эпидемиологии и иммунобиологии0372-93112686-76132022-05-0199220321410.36233/0372-9311-190804Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon modelA. A. Djidaryan0A. Z. Matua1A. Yu. Medkova2E. G. Semin3L. N. Sinyashina4I. N. Dyakov5I. N. Chernyshova6D. T. Kubrava7A. A. Amichba8I. G. Kondzariya9Z. Ya. Mikvabiya10G. I. Karataev11Research Institute of Experimental Pathology and Therapy of the Academy of Sciences of AbkhaziaResearch Institute of Experimental Pathology and Therapy of the Academy of Sciences of AbkhaziaNational Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. GamaleyaNational Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. GamaleyaNational Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. GamaleyaNational Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya; I. Mechnikov Research Institute for Vaccines and SeraNational Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya; I. Mechnikov Research Institute for Vaccines and SeraResearch Institute of Experimental Pathology and Therapy of the Academy of Sciences of AbkhaziaResearch Institute of Experimental Pathology and Therapy of the Academy of Sciences of AbkhaziaResearch Institute of Experimental Pathology and Therapy of the Academy of Sciences of AbkhaziaResearch Institute of Experimental Pathology and Therapy of the Academy of Sciences of AbkhaziaNational Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. GamaleyaIntroduction. The Gamaleya National Center of Epidemiology and Microbiology has developed a live intranasal pertussis vaccine, GamLVP, for protection against whooping cough. It is indicated for vaccination of infants and revaccination of adults of all age groups. Preclinical studies on suckling mice or rats and adult monkeys as well as clinical trials involving adult volunteers demonstrated safety and efficacy of the GamLVP vaccine. The expansion of the GamLVP vaccine to be used for vaccination of infants requires additional preclinical studies to assess its safety and immunogenicity in the most suitable experimental model of infant hamadryas baboons (Papio hamadryas).The aim of the study was to assess safety and immunogenicity of the GamLVP vaccine administered intranasally for a single dose, two-dose, and three-dose immunization of P. hamadryas infants.Materials and methods. The study was performed in three 1–2-month-old P. hamadryas infants kept, together with their mothers, in a separate cage. The results of the complete blood count and biochemical profile tests were measured before and after the immunization and experimental infection. The enzyme immunoassay (EIA) was used to detect any changes in the levels of specific IgG antibodies in sera from the mothers and infants; the agglutination test (AT) was used to measure titers of total anti-pertussis antibodies.Results. The intranasal immunization of P. hamadryas infants with the GamLVP vaccine triggered development of a specific humoral immune response mediated by IgG antibodies (pertussis toxin + filamentous hemagglutinin), increased titers of total agglutinating anti-pertussis antibodies, caused no local and systemic reactions, caused no changes in the complete blood count and biochemical profile. The experimental infection of the GamLVPimmunized P. hamadryas infants did not cause any changes in the laboratory blood test values and any clinical manifestations typical of the pertussis infection.https://microbiol.elpub.ru/jour/article/view/1218pertussislive pertussis vaccineintranasal administrationhamadryas baboonspapio hamadryasexperimental modelimmunogenicitysafety
spellingShingle A. A. Djidaryan
A. Z. Matua
A. Yu. Medkova
E. G. Semin
L. N. Sinyashina
I. N. Dyakov
I. N. Chernyshova
D. T. Kubrava
A. A. Amichba
I. G. Kondzariya
Z. Ya. Mikvabiya
G. I. Karataev
Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon model
Журнал микробиологии, эпидемиологии и иммунобиологии
pertussis
live pertussis vaccine
intranasal administration
hamadryas baboons
papio hamadryas
experimental model
immunogenicity
safety
title Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon model
title_full Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon model
title_fullStr Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon model
title_full_unstemmed Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon model
title_short Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon model
title_sort safety and immunogenicity of live intranasal pertussis vaccine gamlvp in the experimental infant hamadryas baboon model
topic pertussis
live pertussis vaccine
intranasal administration
hamadryas baboons
papio hamadryas
experimental model
immunogenicity
safety
url https://microbiol.elpub.ru/jour/article/view/1218
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