Trial reportJournal of the National Cancer Institute2020
Efficacy, Safety, and Immunogenicity of an Escherichia coli-Produced Bivalent Human Papillomavirus Vaccine: An Interim Analysis of a Randomized Clinical Trial.
Trial report in Journal of the National Cancer Institute, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05808166 (A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.), which is not on this map. Cited by 99 papers, 6 of them syntheses that pooled 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.
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.
A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.
Who cites it
99 citing papers in PubMed, 6 syntheses or guidelines pooled it, 173 citations in OpenAlex.
- Impact of human papillomavirus vaccines in the reduction of infection, precursor lesions, and cervical cancer: A systematic literature review.Human vaccines & immunotherapeutics · 2025Pooled it
- Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis.The Cochrane database of systematic reviews · 2025Pooled it
- Effects of human papillomavirus (HPV) vaccination programmes on community rates of HPV-related disease and harms from vaccination.The Cochrane database of systematic reviews · 2025Pooled it
- Effectiveness of interventions to improve vaccine efficacy: a systematic review and meta-analysis.Systematic reviews · 2025Pooled it
- Comprehensive evaluation of prophylactic HPV vaccines: a systematic review and meta-analysis of efficacy, safety, and immunogenicity in males and females.Frontiers in immunology · 2025Pooled it
- Efficacy, immunogenicity and safety of HPV vaccination in Chinese population: A meta-analysis.Frontiers in public health · 2023Pooled it
- Immunogenicity and safety of co-administeredFrontiers in immunology · 2026Trial
- Efficacy, safety and immunogenicity of a recombinant human papillomavirus bivalent (types 16, 18) vaccine in healthy 18-30-year-old Chinese women: a phase III, double-blind, randomized, controlled trial.BMC infectious diseases · 2025Trial
- Immunogenicity and safety of anFrontiers in immunology · 2025Trial
- Trial
- Safety of hepatitis E vaccination for pregnancy: a post-hoc analysis of a randomized, double-blind, controlled phase 3 clinical trial.Emerging microbes & infections · 2023Trial
- Long-Term immunopersistence and safety of theHuman vaccines & immunotherapeutics · 2022Trial
- Safety and immunogenicity of anHuman vaccines & immunotherapeutics · 2022Trial
- Impact of web-based health education on HPV vaccination uptake among college girl students in Western and Northern China: a follow-up study.BMC women's health · 2022Trial
- Inflammation-related adverse reactions following vaccination potentially indicate a stronger immune response.Emerging microbes & infections · 2021Trial
- Immunogenicity of anHuman vaccines & immunotherapeutics · 2020Trial
- Lot-to-lot consistency study of anHuman vaccines & immunotherapeutics · 2020Trial
- Leveraging the bacteria for enhanced cancer immunotherapy: from a perspective of synthetic biology.Cancer biology & therapy · 2026Review
- Real-world effectiveness of HPV vaccination against high-risk type HPV DNA positivity among adult women aged 18 - 45years in China: A matched test-negative design study.Human vaccines & immunotherapeutics · 2026Article
- Immunogenicity of anVaccines · 2026Article
39 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
45 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe high cost and insufficient supply of human papillomavirus (HPV) vaccines have slowed the pace of controlling cervical cancer. A phase III clinical trial was conducted to evaluate the efficacy, safety, and immunogenicity of a novel Escherichia coli-produced bivalent HPV-16/18 vaccine.
methodsA multicenter, randomized, double-blind trial started on November 22, 2012 in China. In total, 7372 eligible women aged 18-45 years were age-stratified and randomly assigned to receive three doses of the test or control (hepatitis E) vaccine at months 0, 1, and 6. Co-primary endpoints included high-grade genital lesions and persistent infection (over 6 months) associated with HPV-16/18. The primary analysis was performed on a per-protocol susceptible population of individuals who were negative for relevant HPV type-specific neutralizing antibodies (at day 0) and DNA (at day 0 through month 7) and who received three doses of the vaccine. This report presents data from a prespecified interim analysis used for regulatory submission.
resultsIn the per-protocol cohort, the efficacies against high-grade genital lesions and persistent infection were 100.0% (95% confidence interval = 55.6% to 100.0%, 0 of 3306 in the vaccine group vs 10 of 3296 in the control group) and 97.8% (95% confidence interval = 87.1% to 99.9%, 1 of 3240 vs 45 of 3246), respectively. The side effects were mild. No vaccine-related serious adverse events were noted. Robust antibody responses for both types were induced and persisted for at least 42 months.
conclusionsThe E coli-produced HPV-16/18 vaccine is well tolerated and highly efficacious against HPV-16/18-associated high-grade genital lesions and persistent infection in women.
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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.