Immunogenicity and Safety of AS03-Adjuvanted H7N9 Influenza Vaccine in Adults (18–64 and ≥65 Years): A Phase 1/2, Randomized, Placebo-Controlled Trial

IF 4.3 4区医学 Q1 INFECTIOUS DISEASES

Influenza and Other Respiratory Viruses Pub Date : 2024-12-19 DOI:10.1111/irv.70020

Andrew Hastie, Tanya Clarke, Sophie Germain, Thierry Ollinger, Patricia Lese, Vinay Gupta

{"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. 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":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Influenza and Other Respiratory Viruses","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/irv.70020","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}

引用次数: 0

Abstract

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 AS03_A or AS03_B) 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 AS03_A adjuvant versus the AS03_B 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.

Trial Registration: NCT04789577 [ClinicalTrials.gov]

Abstract Image

查看原文本刊更多论文

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

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Influenza and Other Respiratory Viruses 医学-病毒学

CiteScore

7.20

自引率

4.50%

发文量

120

审稿时长

6-12 weeks

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.