A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers
Introduction. The increase in incidence rate of pertussis worldwide, short-term insufficient immunity induced by acellular pertussis vaccines (TDaP) and their failure to provide antibacterial protection and to prevent transmission of infection in human population dictate the development of new pertu...
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Central Research Institute for Epidemiology
2024-12-01
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| Series: | Журнал микробиологии, эпидемиологии и иммунобиологии |
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| Online Access: | https://microbiol.crie.ru/jour/article/viewFile/18724/1552 |
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| author | Alevtina A. Lidzhieva Alisa Yu. Medkova Sergey V. Kulikov Ludmila N. Sinyashina Rezida A. Sioundioukova Andrey P. Markov Aleksey B. Verveda Natalia E. Abaeva Irina N. Chernyshova Marina V. Gavrilova Kristina K. Bushkova Ilya N. Dyakov Gennady I. Karataev |
| author_facet | Alevtina A. Lidzhieva Alisa Yu. Medkova Sergey V. Kulikov Ludmila N. Sinyashina Rezida A. Sioundioukova Andrey P. Markov Aleksey B. Verveda Natalia E. Abaeva Irina N. Chernyshova Marina V. Gavrilova Kristina K. Bushkova Ilya N. Dyakov Gennady I. Karataev |
| author_sort | Alevtina A. Lidzhieva |
| collection | DOAJ |
| description | Introduction. The increase in incidence rate of pertussis worldwide, short-term insufficient immunity induced by acellular pertussis vaccines (TDaP) and their failure to provide antibacterial protection and to prevent transmission of infection in human population dictate the development of new pertussis vaccines. A new live recombinant pertussis vaccine for intranasal use (GamLPV) has completed preclinical studies in experiments on nonhuman primates and 2 phases of clinical trials involving adult healthy volunteers, in which the safety, immunogenicity and protective activity of the GamLPV were proven. Method and scheme of vaccine administration have been worked out.
Aim. Confirmation of the immunogenicity and protective antibacterial potency of GamLPV in a randomized multicenter clinical trial on adult volunteers.
Materials and methods. In this multicenter, clinical, randomized, placebo-controlled, double-blind study 260 healthy adults aged 18–65 years were divided into 2 groups: G1 — 210 volunteers (GamLPV) and G2 — 50 volunteers (placebo). 0.25 ml GamLPV delivered to each nostril (5 × 109 CFU) 60 days apart. Levels of Bordetella pertussis-specific IgG, IgA antibodies in blood serum and levels of B. pertussis-specific secretory IgA antibodies in nasopharyngeal aspirates were measured by ELISA method and agglutination test. The dynamics of elimination of attenuated B. pertussis bacteria after the first and second intranasal administration of GamLPV to volunteers was estimated by using qPCR.
Results. Significant seroconversion of B. pertussis-specific IgG and IgA antibodies and growth of B. pertussis-specific secretory IgA antibody levels in nasal aspirates of volunteers were demonstrated. The dynamics of changes in the levels of IgG and IgA antibodies indicates a booster effect after second vaccination. Attenuated B. pertussis bacteria persist in the nose/oropharynx of vaccinated volunteers. The period of elimination after second vaccination is more than 2 times shorter than the period after the first one. The number of persistent B. pertussis bacteria after the second vaccination is less than 3% of the values after the first vaccination.
Conclusion. High immunogenicity and the formation of antibacterial protection after single and double intranasal vaccination of GamLPV have been proven. |
| format | Article |
| id | doaj-art-faeb67dc5de14b7893d6b4923f01047e |
| institution | Kabale University |
| issn | 0372-9311 2686-7613 |
| language | Russian |
| publishDate | 2024-12-01 |
| publisher | Central Research Institute for Epidemiology |
| record_format | Article |
| series | Журнал микробиологии, эпидемиологии и иммунобиологии |
| spelling | doaj-art-faeb67dc5de14b7893d6b4923f01047e2025-02-06T21:11:31ZrusCentral Research Institute for EpidemiologyЖурнал микробиологии, эпидемиологии и иммунобиологии0372-93112686-76132024-12-01101677979310.36233/0372-9311-5852799A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteersAlevtina A. Lidzhieva0https://orcid.org/0000-0002-1537-6444Alisa Yu. Medkova1https://orcid.org/0000-0002-1509-0622Sergey V. Kulikov2https://orcid.org/0000-0001-7478-3624Ludmila N. Sinyashina3https://orcid.org/0000-0003-1708-5453Rezida A. Sioundioukova4https://orcid.org/0000-0001-5600-1967Andrey P. Markov5https://orcid.org/0009-0000-1857-967XAleksey B. Verveda6https://orcid.org/0000-0003-4029-3170Natalia E. Abaeva7https://orcid.org/0000-0003-3984-959XIrina N. Chernyshova8https://orcid.org/0000-0001-5053-2433Marina V. Gavrilova9https://orcid.org/0000-0002-6936-2486Kristina K. Bushkova10https://orcid.org/0000-0002-4757-0751Ilya N. Dyakov11https://orcid.org/0000-0001-5384-9866Gennady I. Karataev12https://orcid.org/0000-0001-8771-6092N.F. Gamaleya National Research Center for Epidemiology and MicrobiologyN.F. Gamaleya National Research Center for Epidemiology and MicrobiologyN.F. Gamaleya National Research Center for Epidemiology and MicrobiologyN.F. Gamaleya National Research Center for Epidemiology and MicrobiologyN.F. Gamaleya National Research Center for Epidemiology and MicrobiologyN.F. Gamaleya National Research Center for Epidemiology and MicrobiologyResearch Institute of Industrial and Maritime MedicineI.I. Mechnikov Research Institute for Vaccines and SeraI.I. Mechnikov Research Institute for Vaccines and SeraN.F. Gamaleya National Research Center for Epidemiology and MicrobiologyI.I. Mechnikov Research Institute for Vaccines and SeraN.F. Gamaleya National Research Center for Epidemiology and MicrobiologyN.F. Gamaleya National Research Center for Epidemiology and MicrobiologyIntroduction. The increase in incidence rate of pertussis worldwide, short-term insufficient immunity induced by acellular pertussis vaccines (TDaP) and their failure to provide antibacterial protection and to prevent transmission of infection in human population dictate the development of new pertussis vaccines. A new live recombinant pertussis vaccine for intranasal use (GamLPV) has completed preclinical studies in experiments on nonhuman primates and 2 phases of clinical trials involving adult healthy volunteers, in which the safety, immunogenicity and protective activity of the GamLPV were proven. Method and scheme of vaccine administration have been worked out. Aim. Confirmation of the immunogenicity and protective antibacterial potency of GamLPV in a randomized multicenter clinical trial on adult volunteers. Materials and methods. In this multicenter, clinical, randomized, placebo-controlled, double-blind study 260 healthy adults aged 18–65 years were divided into 2 groups: G1 — 210 volunteers (GamLPV) and G2 — 50 volunteers (placebo). 0.25 ml GamLPV delivered to each nostril (5 × 109 CFU) 60 days apart. Levels of Bordetella pertussis-specific IgG, IgA antibodies in blood serum and levels of B. pertussis-specific secretory IgA antibodies in nasopharyngeal aspirates were measured by ELISA method and agglutination test. The dynamics of elimination of attenuated B. pertussis bacteria after the first and second intranasal administration of GamLPV to volunteers was estimated by using qPCR. Results. Significant seroconversion of B. pertussis-specific IgG and IgA antibodies and growth of B. pertussis-specific secretory IgA antibody levels in nasal aspirates of volunteers were demonstrated. The dynamics of changes in the levels of IgG and IgA antibodies indicates a booster effect after second vaccination. Attenuated B. pertussis bacteria persist in the nose/oropharynx of vaccinated volunteers. The period of elimination after second vaccination is more than 2 times shorter than the period after the first one. The number of persistent B. pertussis bacteria after the second vaccination is less than 3% of the values after the first vaccination. Conclusion. High immunogenicity and the formation of antibacterial protection after single and double intranasal vaccination of GamLPV have been proven.https://microbiol.crie.ru/jour/article/viewFile/18724/1552vaccine gamlpvbordetella pertussismulticenter clinical trialvolunteersimmunogenicityprotective potencypertussishumoral immune response |
| spellingShingle | Alevtina A. Lidzhieva Alisa Yu. Medkova Sergey V. Kulikov Ludmila N. Sinyashina Rezida A. Sioundioukova Andrey P. Markov Aleksey B. Verveda Natalia E. Abaeva Irina N. Chernyshova Marina V. Gavrilova Kristina K. Bushkova Ilya N. Dyakov Gennady I. Karataev A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers Журнал микробиологии, эпидемиологии и иммунобиологии vaccine gamlpv bordetella pertussis multicenter clinical trial volunteers immunogenicity protective potency pertussis humoral immune response |
| title | A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers |
| title_full | A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers |
| title_fullStr | A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers |
| title_full_unstemmed | A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers |
| title_short | A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers |
| title_sort | clinical study of the immunogenicity and protective potency of a live recombinant gamlpv vaccine for intranasal use for the prevention of whooping cough in adult volunteers |
| topic | vaccine gamlpv bordetella pertussis multicenter clinical trial volunteers immunogenicity protective potency pertussis humoral immune response |
| url | https://microbiol.crie.ru/jour/article/viewFile/18724/1552 |
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