Evidence map›Paper›PMID 24740596›Full record

Trial reportInternational journal of cancer2014

Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18-25 years: results from a randomized controlled trial.

Feng-Cai Zhu, Wen Chen, Yue-Mei Hu, Ying Hong, Juan Li, Xun Zhang, Yi-Ju Zhang, Qin-Jing Pan, Fang-Hui Zhao, Jia-Xi Yu and 12 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in International journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00779766 (Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects), which is not on this map. Cited by 39 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 6 pooled it
2.8field-weighted citation impact, top 10% of its field
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.

NCT00779766 phase3completednot on this map

Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

TypeinterventionalSponsorGlaxoSmithKlineRan2008 to 2016Enrolled6,081ConditionsInfections, PapillomavirusArmsHPV GSK 580299 vaccine, Placebo control
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 6 syntheses or guidelines pooled it, 70 citations in OpenAlex.

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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

22 authors at 9 institutions in 3 countries.

Feng-Cai ZhuJiangsu Province Center for Disease Prevention and Control, Nanjing, China.
Wen Chen
Yue-Mei Hu
Ying Hong
Juan Li
Xun Zhang
Yi-Ju Zhang
Qin-Jing Pan
Fang-Hui Zhao
Jia-Xi Yu
Yan-Shu Zhang
Xiaoping Yang
Cheng-Fu Zhang
Haiwen Tang
Helen Zhang
Marie Lebacq
Marie-Pierre David
Sanjoy K Datta
Frank Struyf
Dan Bi
Dominique Descamps
HPV-039 study group
GlaxoSmithKline (Belgium) · BEChinese Academy of Medical Sciences & Peking Union Medical College · CNJiangsu Provincial Center for Disease Control and Prevention · CNChinese Center For Disease Control and Prevention · CNGlaxoSmithKline (China) · CNGlaxoSmithKline (United Kingdom) · GBJintan People's Hospital · CNNanjing Drum Tower Hospital · CNNational Institutes for Food and Drug Control · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase II/III, double-blind, randomized trial assessed the efficacy, immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in young Chinese women (ClinicalTrials.gov registration NCT00779766). Women aged 18-25 years from Jiangsu province were randomized (1:1) to receive HPV vaccine (n = 3,026) or Al(OH)3 control (n = 3,025) at months 0, 1 and 6. The primary objective was vaccine efficacy (VE) against HPV-16/18 associated 6-month persistent infection (PI) and/or cervical intraepithelial neoplasia (CIN) 1+. Secondary objectives were VE against virological and clinical endpoints associated with HPV-16/18 and with high-risk HPV types, immunogenicity and safety. Mean follow-up for the according-to-protocol cohort for efficacy (ATP-E) was ∼15 months after the third dose. In the ATP-E (vaccine = 2,889; control = 2,894), for initially HPV DNA negative and seronegative subjects, HPV-16/18 related VE (95% CI) was 94.2% (62.7, 99.9) against 6-month PI and/or CIN1+ and 93.8% (60.2, 99.9) against cytological abnormalities. VE against HPV-16/18 associated CIN1+ and CIN2+ was 100% (-50.4, 100) and 100% (-140.2, 100), respectively (no cases in the vaccine group and 4 CIN1+ and 3 CIN2+ cases in the control group). At Month 7, at least 99.7% of initially seronegative vaccine recipients had seroconverted for HPV-16/18; geometric mean antibody titres (95% CI) were 6,996 (6,212 to 7,880) EU/mL for anti-HPV-16 and 3,309 (2,942 to 3,723) EU/mL for anti-HPV-18. Safety outcomes between groups were generally similar. The HPV-16/18 AS04-adjuvanted vaccine is effective, immunogenic and has a clinically acceptable safety profile in young Chinese women. Prophylactic HPV vaccination has the potential to substantially reduce the burden of cervical cancer in China.

Indexed as

AdolescentAdultChinaDNA, ViralDouble-Blind MethodFemaleFollow-Up StudiesHuman papillomavirus 16Human papillomavirus 18HumansNeoplasm GradingPapillomavirus InfectionsPapillomavirus VaccinesPolymerase Chain ReactionTreatment OutcomeUterine Cervical DysplasiaDNA, ViralPapillomavirus VaccinesChinaefficacyhuman papillomavirus vaccineimmunogenicitysafety

Identifiers

PMID24740596
PMCPMC4277330
OpenAlexW1542956903

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.