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

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1. Title Title of document Safety and immunogenicity of live intranasal pertussis vaccine GamLVP in the experimental infant hamadryas baboon model
2. Creator Author's name, affiliation, country A. A. Djidaryan; Research Institute of Experimental Pathology and Therapy of the Academy of Sciences of Abkhazia;
2. Creator Author's name, affiliation, country A. Z. Matua; Research Institute of Experimental Pathology and Therapy of the Academy of Sciences of Abkhazia;
2. Creator Author's name, affiliation, country A. Yu. Medkova; National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya; Россия
2. Creator Author's name, affiliation, country E. G. Semin; National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya; Россия
2. Creator Author's name, affiliation, country L. N. Sinyashina; National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya; Россия
2. Creator Author's name, affiliation, country I. N. Dyakov; National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya; I. Mechnikov Research Institute for Vaccines and Sera; Россия
2. Creator Author's name, affiliation, country I. N. Chernyshova; National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya; I. Mechnikov Research Institute for Vaccines and Sera; Россия
2. Creator Author's name, affiliation, country D. T. Kubrava; Research Institute of Experimental Pathology and Therapy of the Academy of Sciences of Abkhazia;
2. Creator Author's name, affiliation, country A. A. Amichba; Research Institute of Experimental Pathology and Therapy of the Academy of Sciences of Abkhazia;
2. Creator Author's name, affiliation, country I. G. Kondzariya; Research Institute of Experimental Pathology and Therapy of the Academy of Sciences of Abkhazia;
2. Creator Author's name, affiliation, country Z. Ya. Mikvabiya; Research Institute of Experimental Pathology and Therapy of the Academy of Sciences of Abkhazia;
2. Creator Author's name, affiliation, country G. I. Karataev; National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya; Россия
3. Subject Discipline(s)
3. Subject Keyword(s) pertussis;live pertussis vaccine;intranasal administration;hamadryas baboons;Papio hamadryas;experimental model;immunogenicity;safety
4. Description Abstract

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.

5. Publisher Organizing agency, location Central Research Institute for Epidemiology
6. Contributor Sponsor(s)
7. Date (DD-MM-YYYY) 12.05.2022
8. Type Status & genre Peer-reviewed Article
8. Type Type Unknown
9. Format File format
10. Identifier Uniform Resource Identifier https://microbiol.crie.ru/jour/article/view/1218
10. Identifier Digital Object Identifier (DOI) 10.36233/0372-9311-190
11. Source Title; vol., no. (year) Journal of microbiology, epidemiology and immunobiology; Vol 99, No 2 (2022)
12. Language English=en ru
13. Relation Supp. Files Fig. 1. Changes in the level of specific pertussis IgG immunoglobulins (PT + FHA) in sera from infant monkeys after the intranasal application of the GamLPV vaccine. Vertical axis — OD in the well (the mean of 2 repeats), rel. units. (39KB)
Fig. 2. Changes in titers of agglutination with sera from infant monkeys in DAT after intranasal immunization with the GamLPV vaccine. Vertical axis — the highest titers of agglutination with bacteria B. pertussis. Agglutination of control B. pertussis cultures with sera from mothers 31949, 31993 was absent. (20KB)
Fig. 3. Changes in the levels of specific pertussis IgG immunoglobulins (PT + FHA) in sera from immunized infant monkeys and their mothers after the experimental infection with virulent bacteria B. pertussis 475. Horizontal axis — OD in the well, rel. units; 31949 — the infant’s mother 32317; 31993 — the infant’s mother 32295. (42KB)
Fig. 4. Changes in agglutination titers in sera from immunized infant monkeys and their mothers after the experimental infection with virulent bacteria B. pertussis 475. Horizontal axis — OD in the well, rel. units; 31949 — the infant’s mother 32317; 31993 — the infant’s mother 32295. (24KB)
14. Coverage Geo-spatial location, chronological period, research sample (gender, age, etc.)
15. Rights Copyright and permissions Copyright (c) 2022 Djidaryan A.A., Matua A.Z., Medkova A.Y., Semin E.G., Sinyashina L.N., Dyakov I.N., Chernyshova I.N., Kubrava D.T., Amichba A.A., Kondzariya I.G., Mikvabiya Z.Y., Karataev G.I.
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