Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.

<h4>Objective</h4>In Europe, the age indication for the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) has recently been extended from ≥65 to ≥50 years. Considering that the earliest approval of its trivalent formulation (aTIV) in Italy was for people aged ≥12 years, we aimed to s...

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Main Authors: Alexander Domnich, Carlo-Simone Trombetta, Elettra Fallani, Marco Salvatore
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2024-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0310677
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author Alexander Domnich
Carlo-Simone Trombetta
Elettra Fallani
Marco Salvatore
author_facet Alexander Domnich
Carlo-Simone Trombetta
Elettra Fallani
Marco Salvatore
author_sort Alexander Domnich
collection DOAJ
description <h4>Objective</h4>In Europe, the age indication for the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) has recently been extended from ≥65 to ≥50 years. Considering that the earliest approval of its trivalent formulation (aTIV) in Italy was for people aged ≥12 years, we aimed to systematically appraise data on the immunogenicity, efficacy, and safety of aTIV/aQIV in non-elderly adults.<h4>Methods</h4>A systematic literature review was conducted according to the available guidelines and studies were searched in MEDLINE, Biological Abstracts, Web of Science, Cochrane Library and clinical trial registries. Studies on absolute and relative immunogenicity, efficacy, effectiveness, and safety of aTIV/aQIV in non-elderly adults (<65 years) were potentially eligible. These endpoints were analyzed by virus (sub)types and characteristics of vaccinees. Fixed- and random-effects meta-analyses were performed for data synthesis. Protocol registration: CRD42024512472.<h4>Results</h4>Twenty-four publications were analyzed. aTIV/aQIV was more immunogenic than non-adjuvanted vaccines towards vaccine-like strains: the absolute differences in seroconversion rates were 8.8% (95% CI: 3.7%, 14.0%), 13.1% (95% CI: 6.7%, 19.6%) and 11.7% (95% CI: 7.2%, 16.2%) for A(H1N1), A(H3N2), and B strains, respectively. This immunogenicity advantage was more pronounced in immunosuppressed adults. Additionally, aTIV/aQIV was more immunogenic than non-adjuvanted counterparts towards heterologous A(H3N2) strains with a 10.7% (95% CI: 3.2%, 18.2%) difference in seroconversion rates. Data on antibody persistence and efficacy were limited and inconclusive. Overall, aTIV/aQIV was judged safe and well tolerated, although reactogenic events were more frequent in aTIV/aQIV recipients versus comparators. Serious adverse events were uncommon and no difference (risk ratio 1.02; 95% CI: 0.64, 1.63) between aTIV/aQIV and non-adjuvanted formulations was found.<h4>Conclusions</h4>In non-elderly adults, aTIV/aQIV is safe and generally more immunogenic than non-adjuvanted standard-dose vaccines.
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spelling doaj-art-2f1b0babf8984f1091cf3b3882c9995c2025-01-17T05:31:52ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-011912e031067710.1371/journal.pone.0310677Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.Alexander DomnichCarlo-Simone TrombettaElettra FallaniMarco Salvatore<h4>Objective</h4>In Europe, the age indication for the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) has recently been extended from ≥65 to ≥50 years. Considering that the earliest approval of its trivalent formulation (aTIV) in Italy was for people aged ≥12 years, we aimed to systematically appraise data on the immunogenicity, efficacy, and safety of aTIV/aQIV in non-elderly adults.<h4>Methods</h4>A systematic literature review was conducted according to the available guidelines and studies were searched in MEDLINE, Biological Abstracts, Web of Science, Cochrane Library and clinical trial registries. Studies on absolute and relative immunogenicity, efficacy, effectiveness, and safety of aTIV/aQIV in non-elderly adults (<65 years) were potentially eligible. These endpoints were analyzed by virus (sub)types and characteristics of vaccinees. Fixed- and random-effects meta-analyses were performed for data synthesis. Protocol registration: CRD42024512472.<h4>Results</h4>Twenty-four publications were analyzed. aTIV/aQIV was more immunogenic than non-adjuvanted vaccines towards vaccine-like strains: the absolute differences in seroconversion rates were 8.8% (95% CI: 3.7%, 14.0%), 13.1% (95% CI: 6.7%, 19.6%) and 11.7% (95% CI: 7.2%, 16.2%) for A(H1N1), A(H3N2), and B strains, respectively. This immunogenicity advantage was more pronounced in immunosuppressed adults. Additionally, aTIV/aQIV was more immunogenic than non-adjuvanted counterparts towards heterologous A(H3N2) strains with a 10.7% (95% CI: 3.2%, 18.2%) difference in seroconversion rates. Data on antibody persistence and efficacy were limited and inconclusive. Overall, aTIV/aQIV was judged safe and well tolerated, although reactogenic events were more frequent in aTIV/aQIV recipients versus comparators. Serious adverse events were uncommon and no difference (risk ratio 1.02; 95% CI: 0.64, 1.63) between aTIV/aQIV and non-adjuvanted formulations was found.<h4>Conclusions</h4>In non-elderly adults, aTIV/aQIV is safe and generally more immunogenic than non-adjuvanted standard-dose vaccines.https://doi.org/10.1371/journal.pone.0310677
spellingShingle Alexander Domnich
Carlo-Simone Trombetta
Elettra Fallani
Marco Salvatore
Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.
PLoS ONE
title Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.
title_full Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.
title_fullStr Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.
title_full_unstemmed Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.
title_short Immunogenicity and safety of the MF59-adjuvanted seasonal influenza vaccine in non-elderly adults: A systematic review and meta-analysis.
title_sort immunogenicity and safety of the mf59 adjuvanted seasonal influenza vaccine in non elderly adults a systematic review and meta analysis
url https://doi.org/10.1371/journal.pone.0310677
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