Evidence map›Paper›PMID 37249310›Full record

Trial reportHuman vaccines & immunotherapeutics2023

Safety and immunogenicity of a bivalent HPV16/18 vaccine in Chinese females.

Li-Wei Shi, Juan Li, Bang-Wei Yu, Li-Rong Huang, Ke Li, Min Ji, Ling-Yun Zhou, Lin Yuan, Shu-Yuan Yang, Jing-Jing Chen and 7 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% 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.

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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. 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

17 authors at 7 institutions in 3 countries.

Li-Wei ShiInstitute of Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
Juan LiDivision of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Beijing, China.
Bang-Wei YuDepartment of Regulatory and Medical Affairs, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Li-Rong HuangInstitute of Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
Ke LiDepartment of Regulatory and Medical Affairs, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Min JiDepartment of Regulatory and Medical Affairs, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Ling-Yun ZhouQuality Research Department, Shanghai Zerun Biotechnology Co., Ltd, Shanghai, China.
Lin YuanDepartment of Regulatory and Medical Affairs, Walvax Biotechnology Co. Ltd, Kunming, Yunnan, China.
Shu-Yuan YangDepartment of Regulatory and Medical Affairs, Walvax Biotechnology Co. Ltd, Kunming, Yunnan, China.
Jing-Jing ChenDepartment of Regulatory and Medical Affairs, Walvax Biotechnology Co. Ltd, Kunming, Yunnan, China.
Ling WangDepartment of Health Statistics, Air Force Military Medical University, Xi'an, Shanxi, China.
Zhi-Wei JiangDepartment of Health Statistics, Beijing Key Tech Statistical Technology Co. Ltd, Beijing, China.
Rong-Cheng LiInstitute of Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
Yan-Ping LiInstitute of Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
Jie-Lai XiaDepartment of Health Statistics, Air Force Military Medical University, Xi'an, Shanxi, China.
Zhao-Jun MoInstitute of Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
Chang-Gui LiDivision of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Beijing, China.
Center for Disease Control · TWShanghai CASB Biotechnology (China) · CNWalmart (United States) · USAir Force Medical University · CNNational Institutes for Food and Drug Control · CNGuangxi Center for Disease Prevention and Control · CNStatistical Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As global supply is still inadequate to address the worldwide requirements for HPV vaccines, we assessed the safety and immunogenicity of a new bivalent HPV16/18 vaccine. In this randomized, double-blind, placebo-controlled, phase 2 trial, healthy 9-45-year-old Chinese females in three age cohorts (600 aged 9-17 years; 240 aged 18-26 years; 360 aged 27-45 years) were randomized 1:1 to receive three doses (0,2,6 months) of HPV16/18 vaccine or placebo. We measured neutralizing antibodies against HPV 16 and 18 at 7 months and monitored safety to 12 months in all age cohorts; 9-17-year-old girls were monitored for safety and immunogenicity to 48 months. In vaccinees, 99.8% seroconverted for HPV 16 and 18 types at 7 months; respective GMTs of 5827 (95% CI: 5249, 6468) and 4223 (3785, 4713) were significantly (

Indexed as

Papillomavirus InfectionsPapillomavirus VaccinesAdolescentAdultAntibodies, NeutralizingAntibodies, ViralChildDouble-Blind MethodEast Asian PeopleFemaleHuman papillomavirus 16Human papillomavirus 18HumansImmunogenicity, VaccineMiddle AgedVaccines, CombinedAntibodies, NeutralizingAntibodies, ViralPapillomavirus VaccinesVaccines, CombinedHPVHuman papilloma virusimmunogenicityneutralizing antibodiesreactogenicityvaccine

Identifiers

PMID37249310
PMCPMC10294733
OpenAlexW4378745041

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.