Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine.

Abstract

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 (R lr) appeared to be lower in AZB-adjuvanted vaccine treatment arms versus comparator vaccine treatment arms. 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. Meta‑regression analysis based on a literature search of records or reports of clinical trials featuring AZB and the inactivated subunit of influenza published between 1998–2018 was conducted online in January 2019 and updated in August 2019. This search covered trials performed between 1993 and 2016 and suggested that AZB did not contribute to vaccine reactogenicity.

Expression of Toll-like Receptors on the Immune Cells in Patients with Common Variable Immune Deficiency after Different Schemes of Influenza Vaccination

“…In 2022 there was an analysis conducted of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine, which included trials performed between 1993 and 2016 and comprised 11,736 participants aged between 6 months and 99 years [55]. It showed that Grippol family vaccines induced antibody production in both children and adults up to 60 years at levels similar to vaccines with the standard amount of HA.…”

Вакцинация Населения В Борьбе С Гриппом В Республике Казахстан

“…(Vaccines, Frontiers Immunology, Austin Journal of Vaccines & Immunotherapeutics, Intechopen и др. )[16,17,18,19]. По результатам исследования тривалентную инактивированную субъединичную адъювантную вакцину можно рекомендовать, как препарат выбора в рутинной практике иммунизации в Республике Казахстан, поскольку включенный в состав адъювант (МНН: азоксимера бромид) обладает антиинфекционной, противоопухолевой и детоксицирующей активностью [26].…”