Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. [version 1; peer review: 2 approved]
A systematic review of clinical trials conducted with a low-dose inactivated influenza vaccine adjuvanted by azoximer bromide (AZB, Polyoxidonium), was performed to compare vaccine reactogenicity against non-adjuvant vaccines. We also assessed whether lower amounts of antigen per viral strain in AZB...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2022-03-01
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| Series: | F1000Research |
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| Online Access: | https://f1000research.com/articles/11-259/v1 |
| _version_ | 1828106375509573632 |
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| author | Susanna Kharit Dmitry Lioznov Michail Kostinov Ronald Kompier Tim Hardman Walter Beyer Pieter Neels |
| author_facet | Susanna Kharit Dmitry Lioznov Michail Kostinov Ronald Kompier Tim Hardman Walter Beyer Pieter Neels |
| author_sort | Susanna Kharit |
| collection | DOAJ |
| description | A systematic review of clinical trials conducted with a low-dose inactivated influenza vaccine adjuvanted by azoximer bromide (AZB, Polyoxidonium), was performed to compare vaccine reactogenicity against non-adjuvant vaccines. We also assessed whether lower amounts of antigen per viral strain in AZB-adjuvanted vaccines affected antibody responses. A robust search strategy identified scientific publications reporting 30 clinical trials, comprising data on 11,736 participants and 86 trial arms, for inclusion in the analysis. Local reaction rates (Rlr) appeared to be lower in AZB-adjuvanted vaccine treatment arms versus comparator vaccine treatment arms. Meta‑regression analysis revealed that AZB did not contribute to vaccine reactogenicity. Post-vaccination geometric mean titres in those exposed to AZB-adjuvanted vaccine and comparator vaccine treatment arms were similar in both children and adults aged 18–60 years, implying an antigen-sparing effect by AZB. |
| first_indexed | 2024-04-11T10:15:49Z |
| format | Article |
| id | doaj.art-16145027936a445b8a6e2a8d2a56a0c1 |
| institution | Directory Open Access Journal |
| issn | 2046-1402 |
| language | English |
| last_indexed | 2024-04-11T10:15:49Z |
| publishDate | 2022-03-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | F1000Research |
| spelling | doaj.art-16145027936a445b8a6e2a8d2a56a0c12022-12-22T04:29:58ZengF1000 Research LtdF1000Research2046-14022022-03-011179798Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. [version 1; peer review: 2 approved]Susanna Kharit0Dmitry Lioznov1Michail Kostinov2https://orcid.org/0000-0002-1382-9403Ronald Kompier3Tim Hardman4https://orcid.org/0000-0002-1417-9019Walter Beyer5Pieter Neels6Scientific Research Institute of Children’s Infections of the Russian Federal Biomedical Agency, St. Petersburg, Russian FederationSmorodintsev Research Institute of Influenza, Saint Petersburg, Russian FederationDepartment of Allergology, I.I. Mechnikov Research Institute of Vaccines and Sera, Moscow, Russian FederationRuijgenhoeck 6, 2201 EW Noordwijk, Vaccine Consultancy, The Netherlands, Netherlands AntillesNiche Science and Technology Ltd., Unit 26, Falstaff House, Bardolph Road, Niche Science and Technology, London, UKRuijgenhoeck 6, 2201 EW Noordwijk, Vaccine Consultancy, The Netherlands, Netherlands AntillesVaccine Advice BVBA, Zoersel, BelgiumA systematic review of clinical trials conducted with a low-dose inactivated influenza vaccine adjuvanted by azoximer bromide (AZB, Polyoxidonium), was performed to compare vaccine reactogenicity against non-adjuvant vaccines. We also assessed whether lower amounts of antigen per viral strain in AZB-adjuvanted vaccines affected antibody responses. A robust search strategy identified scientific publications reporting 30 clinical trials, comprising data on 11,736 participants and 86 trial arms, for inclusion in the analysis. Local reaction rates (Rlr) appeared to be lower in AZB-adjuvanted vaccine treatment arms versus comparator vaccine treatment arms. Meta‑regression analysis revealed that AZB did not contribute to vaccine reactogenicity. Post-vaccination geometric mean titres in those exposed to AZB-adjuvanted vaccine and comparator vaccine treatment arms were similar in both children and adults aged 18–60 years, implying an antigen-sparing effect by AZB.https://f1000research.com/articles/11-259/v1influenza vaccine vaccine adjuvant azoximer bromide vaccine safety immunogenicity revieweng |
| spellingShingle | Susanna Kharit Dmitry Lioznov Michail Kostinov Ronald Kompier Tim Hardman Walter Beyer Pieter Neels Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. [version 1; peer review: 2 approved] F1000Research influenza vaccine vaccine adjuvant azoximer bromide vaccine safety immunogenicity review eng |
| title | Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. [version 1; peer review: 2 approved] |
| title_full | Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. [version 1; peer review: 2 approved] |
| title_fullStr | Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. [version 1; peer review: 2 approved] |
| title_full_unstemmed | Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. [version 1; peer review: 2 approved] |
| title_short | Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine. [version 1; peer review: 2 approved] |
| title_sort | analysis of the safety and immunogenicity profile of an azoximer bromide polymer adjuvanted subunit influenza vaccine version 1 peer review 2 approved |
| topic | influenza vaccine vaccine adjuvant azoximer bromide vaccine safety immunogenicity review eng |
| url | https://f1000research.com/articles/11-259/v1 |
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