A post-marketing study to evaluate the safety and immunogenicity of a quadrivalent influenza split-virion vaccine in elderly people aged 60 years and older.

BACKGROUND: Influenza remains a global public health concern. Understanding the vaccination-induced response in an aging population, which is susceptible and at high risk, is essential for disease prevention and control. Here, we report findings on the safety and immunogenicity of a quadrivalent influenza split-virion vaccine (15 µg/subtype/0.5 ml/dose) (hereinafter referred to as the "quadrivalent influenza vaccine") in a population aged ≥ 60 years. METHODS: This open-label, pragmatic post-marketing trial enrolled 1399 older adults to receive one dose of an approved commercially available quadrivalent influenza vaccine manufactured by Hualan Biological Bacterin Inc. (hereinafter referred to as "Hualan Bio"). Participants with contraindications for the vaccine were excluded, while poor health condition was acceptable. All vaccinated subjects experienced adverse events collection within 30 days and serious adverse events within 180 days post-vaccination. 25% subjects, selected randomly, underwent venous blood sampling pre-vaccination and 30 days after post-vaccination, for detecting antibody titers against each subtype of influenza virus by hemagglutination inhibition assay. The incidences of adverse events and antibody titers against each subtype of influenza virus were statistically analyzed using SAS 9.4. RESULTS: No grade 3 adverse reactions occurred within 30 days post-vaccination. The incidences of overall adverse reactions, local adverse reactions and systemic adverse reactions were 3.79%, 2.86% and 1.00%, respectively. No serious adverse reactions occurred within 180 days post-vaccination. There were 350 subjects who completed venous blood sampling pre-vaccination, among whom 348 subjects completed venous blood sampling at 30 days post-vaccination for immunogenicity assessment. With respect to hemagglutination inhibition antibodies against influenza viruses H1N1, H3N2, BV and BY subtypes, at 30 days post-vaccination, the seroconversion rates were 87.64%, 75.57%, 73.28% and 78.74%, respectively; the seropositive rates were 93.97%, 98.56%, 79.31% and 95.40%, respectively; and the geometric mean increase (GMI) in post-immunization/pre-immunization antibodies was 24.80, 7.26, 10.39 and 7.39, respectively. CONCLUSION: One 15 µg/subtype dose of the vaccine had a good safety profile and elicited favorable immunogenicity among subjects aged ≥ 60 years. The results of this study indicate that Hualan Bio quadrivalent influenza vaccine strike balance between safety and immunogenicity, supporting unnecessity to increase dosage or inoculation frequency for further enhancing immunogenicity. TRIAL REGISTRATION: Registered on ClinicalTrials.gov. REGISTRATION NUMBER: NCT06334510. Registered on 28/03/2024 (retrospectively registered).

An explicit review and proposal of an integrated framework system to mitigate the baffling complexities induced by road dust-associated contaminants.

Road dust-associated contaminants (RD-AC) are gradually becoming a much thornier problem, as their monotonous correlations render them carcinogenic, mutagenic, and teratogenic. While many studies have examined the harmful effects of road dust on both humans and the environment, few studies have considered the co-exposure risk and gradient outcomes given the spatial extent of RD-AC. In this spirit, this paper presents in-depth elucidation into the baffling complexities induced by both major and emerging contaminants of road dust through a panorama-to-profile up-to-date review of diverse studies unified by the goal of advancing innovative methods to mitigate these contaminants. The paper thoroughly explores the correlations between RD-AC and provides insights to understand their potential in dispersing saprotrophic microorganisms. It also explores emerging challenges and proposes a novel integrated framework system aimed at thermally inactivating viruses and other pathogenic micro-organisms commingled with RD-AC. The main findings are: (i) the co-exposure risk of both major and emerging contaminants add another layer of complexity, highlighting the need for more holistic framework strategies, given the geospatial morphology of these contaminants; (ii) road dust contaminants show great potential for extended prevalence and severity of viral particles pollution; (iii) increasing trend of environmentally persistent free radicals (EPFRs) in road dust, with studies conducted solely in China thus far; and (iv) substantial hurdle exists in acquiring data concerning acute procedural distress and long-term co-exposure risk to RD-ACs. Given the baffling complexities of RD-ACs, co-exposure risk and the need for innovative mitigation strategies, the study underscore the significance of establishing robust systems for deep road dust contaminants control and future research efforts while recognizing the interconnectivity within the contaminants associated with road dust.