Evidence map›Paper›PMID 35834812›Full record

Trial reportHuman vaccines & immunotherapeutics2022

Safety and immunogenicity of an

Zhao-Jun Mo, Zhao-Feng Bi, Wei Sheng, Qi Chen, Teng Huang, Ming-Qiang Li, Xue-Lian Cui, Ya-Hui Wangjiang, Bi-Zhen Lin, Feng-Zhu Zheng and 10 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Immunogenicity and safety of anFrontiers in immunology · 2025
    Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. 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

20 authors.

Zhao-Jun MoExpanded Program on Immunization Department, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
Zhao-Feng BiState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Wei ShengState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Qi ChenState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Teng HuangExpanded Program on Immunization Department, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, China.
Ming-Qiang LiLiuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.
Xue-Lian CuiLiuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.
Ya-Hui WangjiangState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Bi-Zhen LinVaccine R&D Department, Xiamen Innovax Biotech Company, Xiamen, Fujian, China.
Feng-Zhu ZhengVaccine R&D Department, Xiamen Innovax Biotech Company, Xiamen, Fujian, China.
Guang SunVaccine R&D Department, Xiamen Innovax Biotech Company, Xiamen, Fujian, China.
Ya-Fei LiState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Ya ZhengState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Si-Jie ZhuangState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Ying-Ying SuState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Hui-Rong PanVaccine R&D Department, Xiamen Innovax Biotech Company, Xiamen, Fujian, China.
Shou-Jie HuangState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.
Ting WuState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.ORCID 0000-0002-1806-3056
Jun ZhangState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.ORCID 0000-0002-6601-9180
Ning-Shao XiaState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, Xiamen University, Xiamen, Fujian, China.ORCID 0000-0003-0179-5266

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A dose-escalation, randomized, double-blind, placebo-controlled phase 1 clinical trial enrolled 145 eligible participants aged 18-55 years in March 2015 in Liuzhou, China. Stratified by age and sex, the participants were randomly assigned to receive either 30, 60, or 90 μg of the HPV-6/11 vaccine (n = 41/40/40) or the parallel placebo vaccine (n = 8/8/8) with a 0/1/6-month dose-escalation schedule. Participants were actively followed-up to record local and systemic AEs occurring within 30 days after each vaccination, and SAEs occurred in 7 months. Blood and urine samples of each participant were collected before and 2 days after the first and third vaccination to determine changes in routine blood, serum biochemical, and urine indexes. Serum HPV-6/11-specific IgG and neutralizing antibody levels at month 7 were analyzed. A total of 79 adverse events were reported, and no SAEs occurred. The incidences of total adverse reactions in the 30 μg, 60 μg, and 90 μg HPV vaccine groups and the control group were 31.7%, 50.0%, 42.5%, and 62.5%, respectively. All but one of the adverse reactions was mild or moderate with grade 1 or 2. No vaccine-related changes with clinical significance were found in paired blood and urine indexes before and after vaccinations. All the participants in the per-protocol set seroconverted at month 7 for both IgG and neutralizing antibodies. The candidate novel

Indexed as

Human Papillomavirus VirusesPapillomavirus VaccinesAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodEscherichia coliHumansImmunogenicity, VaccineImmunoglobulin GAntibodies, NeutralizingAntibodies, ViralImmunoglobulin GPapillomavirus Vaccinesgenital wartsHuman papillomavirusimmunogenicityphase 1 clinical trialsafetyvaccine

Identifiers

PMID35834812
PMCPMC9746527

What OpenQuestion holds

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Registered trials

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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.