Trial reportJournal of gynecologic oncology2019
A phase 1/2a, dose-escalation, safety and preliminary efficacy study of oral therapeutic vaccine in subjects with cervical intraepithelial neoplasia 3.
Trial report in Journal of gynecologic oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02195089 (A Phase 1/2a Trial to Evaluate the Efficacy and the Safety of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia), which is not on this map. Cited by 26 papers, 2 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 1/2a Trial to Evaluate the Efficacy and the Safety of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Pooled it
- Effectiveness and Safety of Therapeutic Vaccines for Precancerous Cervical Lesions: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2022Pooled it
- Phase I and II randomized clinical trial of an oral therapeutic vaccine targeting human papillomavirus for treatment of cervical intraepithelial neoplasia 2 and 3.JNCI cancer spectrum · 2023Trial
- Leveraging the bacteria for enhanced cancer immunotherapy: from a perspective of synthetic biology.Cancer biology & therapy · 2026Review
- Mucosal immunity: mechanism and application in cancer immunotherapy.Journal of hematology & oncology · 2026Review
- The current landscape of therapeutic vaccination approaches for treatment of HPV-dependent malignancies.NPJ vaccines · 2026Review
- Bacteria in neoplastic diseases: A brief note on Wilms tumor.World journal of experimental medicine · 2025Review
- Human Papillomavirus: An Old New History.Pathogens (Basel, Switzerland) · 2025Review
- Human Papillomavirus and Other Relevant Issues in Cervical Cancer Pathogenesis.International journal of molecular sciences · 2025Review
- Exploring the Intricacies of Cervical Intraepithelial Neoplasia and Its Connection with HPV: A Narrative Review.Iranian journal of public health · 2024Review
- HPV Infections-Classification, Pathogenesis, and Potential New Therapies.International journal of molecular sciences · 2024Review
- Current status and future directions for the development of human papillomavirus vaccines.Frontiers in immunology · 2024Review
- Evaluation of Immune Response to Mucosal Immunization with an Oral Probiotic-Based Vaccine in Mice: Potential for Prime-Boost Immunization against SARS-CoV-2.International journal of molecular sciences · 2023Article
- SARS-CoV-2 Spike Protein-Expressing Enterococcus for Oral Vaccination: Immunogenicity and Protection.Vaccines · 2023Article
- The potential use of bacteria and bacterial derivatives as drug delivery systems for viral infection.Virology journal · 2023Review
- Human papillomavirus associated cervical lesion: pathogenesis and therapeutic interventions.MedComm · 2023Review
- Use of probiotic lactobacilli in the treatment of vaginal infections:Frontiers in cellular and infection microbiology · 2023Review
- DoesCancers · 2022Review
- Potential effectiveness of a therapeutic HPV intervention campaign in Uganda.International journal of cancer · 2022Article
- The role of probiotics in vaginal health.Frontiers in cellular and infection microbiology · 2022Review
Corrections and comments
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Authors and funding
8 authors at 6 institutions in 1 country.
Funding
Abstract
objectivePersistent infection of HPV increases the chance of carcinoma in situ of cervix through stages of cervical intraepithelial neoplasia (CIN) 1, 2, and 3, and finally progresses into cervical cancer. We aimed to explore the safety and efficacy of BLS-M07 which is orally administered agent expressing human papillomavirus (HPV) 16 E7 antigen on the surface of
methodsPatients with CIN 3 were recruited in our clinical trial. Reid Colposcopic Index (RCI) grading and serum HPV16 E7 specific antibody production were used to evaluate efficacy of BLS-M07. In phase 1, BLS-M07 was administered orally, 5 times a week, on weeks 1, 2, 4, and 8 with dosages of 500 mg, 1,000 mg, and 1,500 mg. In phase 2a, patients were treated with 1,000 mg. The primary endpoints were the safety and the pathologic regression on colposcopic biopsy.
resultsNineteen patients were enrolled in the CIN 3 cohort. In phase 1, no patients experienced dose limiting toxicity. No grade 3 or 4 treatment-related adverse events or deaths were observed. At 16 weeks after treatment, RCI grading was improved and serum HPV16 E7 specific antibody production increased (p<0.05). Six of 8 (75%) patients with CIN 3 were cured in phase 2a.
conclusionsOral immunization with BLS-M07 increases production of serum HPV16 E7 specific antibody which induces protective humoral immunity. The safety of this oral vaccine was proved and could be a competitive non-surgical therapeutic agent of CIN 3.
trial registrationClinicalTrials.gov Identifier: NCT02195089.
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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.