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A Multiseason Randomized Controlled Trial of Advax-Adjuvanted Seasonal Influenza Vaccine in Participants With Chronic Disease or Older Age.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 2024 Aug 16; Vol. 230 (2), pp. 444-454. - Publication Year :
- 2024
-
Abstract
- Background: The aim of the current study was to determine the safety and immunogenicity of trivalent inactivated influenza vaccine (TIV) alone or formulated with Advax delta inulin adjuvant in those who were older (aged >60 years) or had chronic disease.<br />Methods: Over 4 consecutive years from 2008 through 2011, adult participants with chronic disease or >60 years of age were recruited into a randomized controlled study to assess the safety, tolerability and immunogenicity of Advax-adjuvanted TIV (TIV + Adj) versus standard TIV. The per-protocol population with ≥1 postbaseline measurement of influenza antibodies comprised 1297 participants, 447 in the TIV and 850 in the TIV + Adj) group.<br />Results: No safety issues were identified. Variables negatively affecting vaccine responses included obesity and diabetes mellitus. Advax adjuvant had a positive impact on anti-influenza immunoglobulin M responses and on H3N2 and B strain seropositivity as assessed by hemagglutination inhibition.<br />Conclusions: TIV + Adj was safe and well tolerated in individuals with chronic disease. There is an ongoing need for research into improved influenza vaccines for high-risk populations.<br />Clinical Trials Registration: Australia New Zealand Clinical Trial Registry: ACTRN 12608000364370.<br />Competing Interests: Potential conflicts of interest. Y. H. O. and N. P. are affiliated with Vaxine, which holds proprietary rights over Advax adjuvant. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.<br /> (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Subjects :
- Humans
Male
Aged
Middle Aged
Female
Chronic Disease
Aged, 80 and over
Adjuvants, Vaccine administration & dosage
Adult
Vaccines, Inactivated immunology
Vaccines, Inactivated administration & dosage
Influenza A Virus, H3N2 Subtype immunology
Influenza B virus immunology
Immunogenicity, Vaccine
Hemagglutination Inhibition Tests
Young Adult
Influenza Vaccines immunology
Influenza Vaccines administration & dosage
Influenza Vaccines adverse effects
Influenza, Human prevention & control
Antibodies, Viral blood
Antibodies, Viral immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6613
- Volume :
- 230
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 38157402
- Full Text :
- https://doi.org/10.1093/infdis/jiad589