Andrew Hastie, Tanya Clarke, Sophie Germain, Thierry Ollinger, Patricia Lese, Vinay Gupta
{"title":"成人（18-64 岁和≥65 岁）接种 AS03 佐剂 H7N9 流感疫苗的免疫原性和安全性：1/2期随机安慰剂对照试验","authors":"Andrew Hastie, Tanya Clarke, Sophie Germain, Thierry Ollinger, Patricia Lese, Vinay Gupta","doi":"10.1111/irv.70020","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Influenza A/Hong Kong/125/2017 (H7N9) virus poses a pandemic risk owing to its evolving nature. This study evaluated the immunogenicity and safety of an AS03-adjuvanted H7N9 vaccine in adults (18–64 years [younger] and ≥65 years [older]).</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Participants (younger, <i>n</i> = 418; older, <i>n</i> = 420) were randomized to receive one of six adjuvanted vaccines (hemagglutinin [1.9 μg, 3.75 μg, and 7.5 μg] with AS03<sub>A</sub> or AS03<sub>B</sub>) or placebo. The co-primary objectives were to determine whether the adjuvanted vaccines elicit an immune response against the vaccine-homologous virus 21 days after the second vaccine dose and to evaluate the safety of the vaccines.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>H7N9 AS03-adjuvanted vaccines at various doses showed a humoral immune response but failed to meet CBER immunogenicity criteria. However, a trend of increased immune responses was observed with the AS03<sub>A</sub> adjuvant versus the AS03<sub>B</sub> adjuvant, particularly in older adults. In both age groups, injection site pain and fatigue occurred more frequently with adjuvanted vaccines. No reported serious adverse events were vaccine-related.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>This study did not achieve its primary objective at any dose level. The modest immune response to AS03-adjuvanted vaccines, consistent with other studies using similar antigens, highlights the need for continued research for H7N9 pandemic preparedness.</p>\n \n <p><b>Trial Registration:</b> NCT04789577 [ClinicalTrials.gov]</p>\n </section>\n </div>","PeriodicalId":13544,"journal":{"name":"Influenza and Other Respiratory Viruses","volume":"18 12","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/irv.70020","citationCount":"0","resultStr":"{\"title\":\"Immunogenicity and Safety of AS03-Adjuvanted H7N9 Influenza Vaccine in Adults (18–64 and ≥65 Years): A Phase 1/2, Randomized, Placebo-Controlled Trial\",\"authors\":\"Andrew Hastie, Tanya Clarke, Sophie Germain, Thierry Ollinger, Patricia Lese, Vinay Gupta\",\"doi\":\"10.1111/irv.70020\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Influenza A/Hong Kong/125/2017 (H7N9) virus poses a pandemic risk owing to its evolving nature. This study evaluated the immunogenicity and safety of an AS03-adjuvanted H7N9 vaccine in adults (18–64 years [younger] and ≥65 years [older]).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>Participants (younger, <i>n</i> = 418; older, <i>n</i> = 420) were randomized to receive one of six adjuvanted vaccines (hemagglutinin [1.9 μg, 3.75 μg, and 7.5 μg] with AS03<sub>A</sub> or AS03<sub>B</sub>) or placebo. The co-primary objectives were to determine whether the adjuvanted vaccines elicit an immune response against the vaccine-homologous virus 21 days after the second vaccine dose and to evaluate the safety of the vaccines.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>H7N9 AS03-adjuvanted vaccines at various doses showed a humoral immune response but failed to meet CBER immunogenicity criteria. However, a trend of increased immune responses was observed with the AS03<sub>A</sub> adjuvant versus the AS03<sub>B</sub> adjuvant, particularly in older adults. In both age groups, injection site pain and fatigue occurred more frequently with adjuvanted vaccines. No reported serious adverse events were vaccine-related.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>This study did not achieve its primary objective at any dose level. 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Immunogenicity and Safety of AS03-Adjuvanted H7N9 Influenza Vaccine in Adults (18–64 and ≥65 Years): A Phase 1/2, Randomized, Placebo-Controlled Trial
Background
Influenza A/Hong Kong/125/2017 (H7N9) virus poses a pandemic risk owing to its evolving nature. This study evaluated the immunogenicity and safety of an AS03-adjuvanted H7N9 vaccine in adults (18–64 years [younger] and ≥65 years [older]).
Methods
Participants (younger, n = 418; older, n = 420) were randomized to receive one of six adjuvanted vaccines (hemagglutinin [1.9 μg, 3.75 μg, and 7.5 μg] with AS03A or AS03B) or placebo. The co-primary objectives were to determine whether the adjuvanted vaccines elicit an immune response against the vaccine-homologous virus 21 days after the second vaccine dose and to evaluate the safety of the vaccines.
Results
H7N9 AS03-adjuvanted vaccines at various doses showed a humoral immune response but failed to meet CBER immunogenicity criteria. However, a trend of increased immune responses was observed with the AS03A adjuvant versus the AS03B adjuvant, particularly in older adults. In both age groups, injection site pain and fatigue occurred more frequently with adjuvanted vaccines. No reported serious adverse events were vaccine-related.
Conclusions
This study did not achieve its primary objective at any dose level. The modest immune response to AS03-adjuvanted vaccines, consistent with other studies using similar antigens, highlights the need for continued research for H7N9 pandemic preparedness.
期刊介绍：
Influenza and Other Respiratory Viruses is the official journal of the International Society of Influenza and Other Respiratory Virus Diseases - an independent scientific professional society - dedicated to promoting the prevention, detection, treatment, and control of influenza and other respiratory virus diseases.
Influenza and Other Respiratory Viruses is an Open Access journal. Copyright on any research article published by Influenza and Other Respiratory Viruses is retained by the author(s). Authors grant Wiley a license to publish the article and identify itself as the original publisher. Authors also grant any third party the right to use the article freely as long as its integrity is maintained and its original authors, citation details and publisher are identified.
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