Evidence map›Paper›PMID 42188816›Full record

ArticleVaccines2026

Evaluation of Safety and Immunogenicity of High-Dose Quadrivalent Seasonal Influenza Split Vaccine: A Preclinical Study.

Lanxin Jia, Ran Qiu, Jing Liu, Bo Liu, Xuanxuan Nian, Yang Le, Xixin Han, Qingmei Zhang, Xuedan Li, Zheng Gong and 4 more

Abstract read
In one paragraph

Article in Vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Lanxin JiaWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Ran QiuWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Jing LiuWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Bo LiuWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Xuanxuan NianWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Yang LeWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Xixin HanWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Qingmei ZhangWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Xuedan LiWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Zheng GongWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Ailin ShenWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Zhegang ZhangWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.
Ying ZhaoDepartment of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
Jiayou ZhangWuhan Institute of Biological Products Co., Ltd., Wuhan 430022, China.

Funding

National Natural Science Foundation of China 82104317Science and Technology Department of Hubei Province 2022CFB254Science and Technology Department of Hubei Province 2023BCB028
6 · The paper itself

Abstract

objectivesSeasonal influenza leads to substantial global morbidity and mortality, especially in adults aged 65 years and older, who present poor immune responses to standard-dose influenza vaccines. This study aimed to systematically evaluate the preclinical safety and immunogenicity of a high-dose quadrivalent seasonal influenza split vaccine (HD-QIV), providing preclinical evidence for its clinical application in the elderly.

methodsFollowing GLP guidelines, we performed single-dose and repeated-dose toxicity tests in Sprague-Dawley rats, active systemic anaphylaxis assays in guinea pigs, and immunogenicity assessments in young and aged BALB/c mice. Safety indicators included general clinical signs, hematology, blood biochemistry, histopathology and allergic reactions; immunogenicity was evaluated via hemagglutination inhibition (HI) antibody titers and antigen-specific cellular immune responses.

resultsHD-QIV only caused mild and reversible local irritation in rats without obvious systemic toxicity, and no dose-related systemic anaphylaxis was observed in guinea pigs. HD-QIV induced robust and dose-dependent humoral immune responses, and showed significantly higher HI antibody titers, earlier seroconversion and longer antibody persistence than standard quadrivalent influenza vaccine in aged mice. Cellular immunity was slightly enhanced but not the dominant protective response.

conclusionsThe HD-QIV demonstrates favorable preclinical safety and superior immunogenicity, supporting its further clinical development and use as a priority vaccine for the elderly population.

Indexed as

aged micehigh-dose quadrivalent influenza vaccineimmunogenicitypreclinical studysafety

Identifiers

PMID42188816
PMCPMC13211341

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.