Evidence map›Paper›PMID 40919385›Full record

ArticleThe Lancet regional health. Western Pacific2025

Immunogenicity comparison of an

Guo-Hua Zhong, Zhao-Feng Bi, Kai Chu, Li Zhang, Lu Chen, Kong-Xin Zhu, Jia-Li Quan, Chu Nie, Qi Chen, Ling-Xian Qiu and 14 more

2 registry-linked trialsAbstract read
In one paragraph

Article in The Lancet regional health. Western Pacific, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04782895 phase3completednot on this map

A Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age

TypeinterventionalSponsorXiamen UniversityRan2021 to 2022Enrolled488ConditionsCervical Cancer, Condylomata AcuminataArmsRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli), Gardasil®9
NCT06197802 active not recruitingnot on this map

An Observational Study to Compare Plateau Antibody Levels of a Recombinant (E.Coli) Human Papillomavirus Nonavalent (Type 6/11/16/18/31/33/45/52/58) Vaccine Versus Gardasil®9 in Healthy Females 18-26 Years of Age

TypeobservationalSponsorXiamen UniversityRan2023 to 2025Enrolled392ConditionsCervical Cancer, Condylomata AcuminataArmsRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli), Gardasil®9
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
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

24 authors.

Guo-Hua ZhongState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Zhao-Feng BiState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Kai ChuJiangsu Provincial Centre for Disease Control and Prevention, Public Health Research Institute of Jiangsu Province, Nanjing, Jiangsu, China.
Li ZhangNational Institutes for Food and Drug Control, Beijing, China.
Lu ChenState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Kong-Xin ZhuState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Jia-Li QuanState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Chu NieState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Qi ChenState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Ling-Xian QiuState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Jin-Bo XuGanyu Centre for Disease Control and Prevention, Lianyungang, Jiangsu, China.
Jia-Xue LiGanyu Centre for Disease Control and Prevention, Lianyungang, Jiangsu, China.
Ming-Lei ZhangGanyu Centre for Disease Control and Prevention, Lianyungang, Jiangsu, China.
Sheng LiuGanyu Centre for Disease Control and Prevention, Lianyungang, Jiangsu, China.
Ling-Ling NieNational Institutes for Food and Drug Control, Beijing, China.
Kun LiXiamen Innovax Biotech Company, Xiamen, Fujian, China.
Ying-Ying SuState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Shou-Jie HuangState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Qiu-Fen ZhangXiamen Innovax Biotech Company, Xiamen, Fujian, China.
Wei-Jin HuangNational Institutes for Food and Drug Control, Beijing, China.
Hong-Xing PanJiangsu Provincial Centre for Disease Control and Prevention, Public Health Research Institute of Jiangsu Province, Nanjing, Jiangsu, China.
Ting WuState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Jun ZhangState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Ning-Shao XiaState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Cecolin9, a second-generation 9-valent HPV vaccine derived from the WHO-prequalified Cecolin, has received marketing authorisation in China in May 2025. The non-inferiority of type-specific immune responses between Cecolin9 and Gardasil9 has been previously established at month 7 in Chinese women aged 18-26 years (NCT04782895). This study aimed to compare the plateau antibody levels between the two vaccines three years post the first dose. Methods: This was a prospective extension study of a randomised, single-blind trial conducted in China (ClinicalTrials.gov, NCT06197802). All the participants included in the base study were invited to participate in this extension. Blood samples were collected at year 3 (median follow-up time of 34 months) for neutralising antibody detection, assessed by a triple-colour pseudovirion-based neutralisation assay. The primary outcome, geometric mean concentrations (GMCs), was analysed within three-dose recipients without major protocol violations, seronegative for the relevant type at baseline, and with available serum results at year 3. Non-inferiority of the GMC ratios (Cecolin9 Findings: Of the 487 participants enrolled in the base study, 82.8% (403/487) completed the three-year follow-up visit. The mean age at the first vaccination was 22.2 years among the 200 Cecolin9 recipients and 22.1 years among the 203 Gardasil9 recipients, respectively. The GMC ratios (Cecolin9 Interpretation: The Cecolin9 cohort demonstrated sustained non-inferior HPV type-specific plateau antibody levels compared to the Gardasil9 cohort, supporting Cecolin9's potential for enduring protection. Funding: National Key Research and Development Plan, the National Natural Science Foundation of China, Beijing Natural Science Foundation, Fundamental Research Funds for the Central Universities, the Fieldwork Funds for graduate students of Xiamen University, and Xiamen Innovax.

Indexed as

9-ValentCecolinEscherichia coli-ProducedHuman papillomavirus vaccineImmunogenicityNon-inferiorityPlateau antibody levels

Identifiers

PMID40919385
PMCPMC12408396

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Registered trials

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.