Safety, immunogenicity, and protective efficacy of the intranasal live pertussis vaccine GamLPV in an infant monkey model (<i>Papio hamadryas</i>)
INTRODUCTION. The current progressive increase in pertussis incidence and infant mortality rates is due to the insufficient effectiveness of existing vaccines, both in Russia and worldwide. Previous clinical trials showed that healthy adult volunteers developed long-term antibacterial immunity after...
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2024-12-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/596 |
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| author | D. T. Kubrava A. Yu. Medkova A. Z. Matua I. G. Kondzariya A. A. Amichba Kh. Z. Trapsh L. V. Gamgiya S. G. Kulikov L. N. Sinyashina Z. Ya. Mikvabiya G. I. Karataev |
| author_facet | D. T. Kubrava A. Yu. Medkova A. Z. Matua I. G. Kondzariya A. A. Amichba Kh. Z. Trapsh L. V. Gamgiya S. G. Kulikov L. N. Sinyashina Z. Ya. Mikvabiya G. I. Karataev |
| author_sort | D. T. Kubrava |
| collection | DOAJ |
| description | INTRODUCTION. The current progressive increase in pertussis incidence and infant mortality rates is due to the insufficient effectiveness of existing vaccines, both in Russia and worldwide. Previous clinical trials showed that healthy adult volunteers developed long-term antibacterial immunity after vaccination with GamLPV, an intranasal recombinant live pertussis vaccine developed by the National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya. Further clinical development of GamLPV in paediatric volunteers, including infants, requires preclinical studies in a newborn monkey model.AIM. This study aimed to evaluate the safety, immunogenicity, and protective efficacy of the GamLPV vaccine in infant hamadryas baboons (Papio hamadryas) challenged with pertussis after intranasal vaccination.MATERIALS AND METHODS. The study used 20 hamadryas baboons, including 7 infants aged 1–1.5 months, 7 mothers of these infants, and 6 control animals. The study examined the time course of changes in serum levels of specific IgG antibodies to pertussis toxin (PT) and filamentous haemagglutinin (FHA) by enzyme-linked immunosorbent assay (ELISA), monitored changes in serum levels of Bordetella pertussis antibodies by agglutination immunoassay, and detected B. pertussis DNA in oropharyngeal aspirates by real-time polymerase chain reaction.RESULTS. Intranasal GamLPV administration to infant baboons induced the production of specific IgG antibodies to PT and FHA (ELISA) and an increase in the total pertussis antibody titre (agglutination immunoassay). GamLPV did not cause any injection site or systemic reactions. There were no changes in complete blood counts and serum biochemistry profiles after vaccination. The protective efficacy of GamLPV against B. pertussis was demonstrated in challenge tests, where immunised animals had no clinical signs or laboratory findings indicative of pertussis in contrast to controls.CONCLUSIONS. The study demonstrated the safety and immunogenicity of the intranasal live pertussis vaccine GamLPV in newborn hamadryas baboons. GamLPV shows promise in the primary vaccination of infants, the revaccination of children and adults, and the development of herd immunity against pertussis in families. |
| format | Article |
| id | doaj-art-7f431c8ee93941c8b5d8bbe72887e2df |
| institution | Kabale University |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| publishDate | 2024-12-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj-art-7f431c8ee93941c8b5d8bbe72887e2df2025-08-20T03:59:39ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562024-12-0124436337610.30895/2221-996X-2024-24-4-363-376392Safety, immunogenicity, and protective efficacy of the intranasal live pertussis vaccine GamLPV in an infant monkey model (<i>Papio hamadryas</i>)D. T. Kubrava0A. Yu. Medkova1A. Z. Matua2I. G. Kondzariya3A. A. Amichba4Kh. Z. Trapsh5L. V. Gamgiya6S. G. Kulikov7L. N. Sinyashina8Z. Ya. Mikvabiya9G. I. Karataev10Research Institute of Experimental Pathology and Therapy, Academy of Sciences of AbkhaziaNational Research Center for Epidemiology and Microbiology named after the honorary academician N.F. GamaleyaResearch Institute of Experimental Pathology and Therapy, Academy of Sciences of AbkhaziaResearch Institute of Experimental Pathology and Therapy, Academy of Sciences of AbkhaziaResearch Institute of Experimental Pathology and Therapy, Academy of Sciences of AbkhaziaResearch Institute of Experimental Pathology and Therapy, Academy of Sciences of AbkhaziaResearch Institute of Experimental Pathology and Therapy, Academy of Sciences of AbkhaziaNational Research Center for Epidemiology and Microbiology named after the honorary academician N.F. GamaleyaNational Research Center for Epidemiology and Microbiology named after the honorary academician N.F. GamaleyaResearch Institute of Experimental Pathology and Therapy, Academy of Sciences of AbkhaziaNational Research Center for Epidemiology and Microbiology named after the honorary academician N.F. GamaleyaINTRODUCTION. The current progressive increase in pertussis incidence and infant mortality rates is due to the insufficient effectiveness of existing vaccines, both in Russia and worldwide. Previous clinical trials showed that healthy adult volunteers developed long-term antibacterial immunity after vaccination with GamLPV, an intranasal recombinant live pertussis vaccine developed by the National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya. Further clinical development of GamLPV in paediatric volunteers, including infants, requires preclinical studies in a newborn monkey model.AIM. This study aimed to evaluate the safety, immunogenicity, and protective efficacy of the GamLPV vaccine in infant hamadryas baboons (Papio hamadryas) challenged with pertussis after intranasal vaccination.MATERIALS AND METHODS. The study used 20 hamadryas baboons, including 7 infants aged 1–1.5 months, 7 mothers of these infants, and 6 control animals. The study examined the time course of changes in serum levels of specific IgG antibodies to pertussis toxin (PT) and filamentous haemagglutinin (FHA) by enzyme-linked immunosorbent assay (ELISA), monitored changes in serum levels of Bordetella pertussis antibodies by agglutination immunoassay, and detected B. pertussis DNA in oropharyngeal aspirates by real-time polymerase chain reaction.RESULTS. Intranasal GamLPV administration to infant baboons induced the production of specific IgG antibodies to PT and FHA (ELISA) and an increase in the total pertussis antibody titre (agglutination immunoassay). GamLPV did not cause any injection site or systemic reactions. There were no changes in complete blood counts and serum biochemistry profiles after vaccination. The protective efficacy of GamLPV against B. pertussis was demonstrated in challenge tests, where immunised animals had no clinical signs or laboratory findings indicative of pertussis in contrast to controls.CONCLUSIONS. The study demonstrated the safety and immunogenicity of the intranasal live pertussis vaccine GamLPV in newborn hamadryas baboons. GamLPV shows promise in the primary vaccination of infants, the revaccination of children and adults, and the development of herd immunity against pertussis in families.https://www.biopreparations.ru/jour/article/view/596pertussislive pertussis vaccineintranasal administrationmonkeyshamadryas baboonspapio hamadryasexperimental modelimmunogenicitysafetyprotective efficacy |
| spellingShingle | D. T. Kubrava A. Yu. Medkova A. Z. Matua I. G. Kondzariya A. A. Amichba Kh. Z. Trapsh L. V. Gamgiya S. G. Kulikov L. N. Sinyashina Z. Ya. Mikvabiya G. I. Karataev Safety, immunogenicity, and protective efficacy of the intranasal live pertussis vaccine GamLPV in an infant monkey model (<i>Papio hamadryas</i>) Биопрепараты: Профилактика, диагностика, лечение pertussis live pertussis vaccine intranasal administration monkeys hamadryas baboons papio hamadryas experimental model immunogenicity safety protective efficacy |
| title | Safety, immunogenicity, and protective efficacy of the intranasal live pertussis vaccine GamLPV in an infant monkey model (<i>Papio hamadryas</i>) |
| title_full | Safety, immunogenicity, and protective efficacy of the intranasal live pertussis vaccine GamLPV in an infant monkey model (<i>Papio hamadryas</i>) |
| title_fullStr | Safety, immunogenicity, and protective efficacy of the intranasal live pertussis vaccine GamLPV in an infant monkey model (<i>Papio hamadryas</i>) |
| title_full_unstemmed | Safety, immunogenicity, and protective efficacy of the intranasal live pertussis vaccine GamLPV in an infant monkey model (<i>Papio hamadryas</i>) |
| title_short | Safety, immunogenicity, and protective efficacy of the intranasal live pertussis vaccine GamLPV in an infant monkey model (<i>Papio hamadryas</i>) |
| title_sort | safety immunogenicity and protective efficacy of the intranasal live pertussis vaccine gamlpv in an infant monkey model i papio hamadryas i |
| topic | pertussis live pertussis vaccine intranasal administration monkeys hamadryas baboons papio hamadryas experimental model immunogenicity safety protective efficacy |
| url | https://www.biopreparations.ru/jour/article/view/596 |
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