Trial reportCancer immunology, immunotherapy : CII2012
A placebo-controlled randomized HPV16 synthetic long-peptide vaccination study in women with high-grade cervical squamous intraepithelial lesions.
Trial report in Cancer immunology, immunotherapy : CII, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
53 citing papers in PubMed, 1 synthesis or guideline pooled it, 92 citations in OpenAlex.
- Effectiveness and Safety of Therapeutic Vaccines for Precancerous Cervical Lesions: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2022Pooled it
- The long-term immune response after HPV16 peptide vaccination in women with low-grade pre-malignant disorders of the uterine cervix: a placebo-controlled phase II study.Cancer immunology, immunotherapy : CII · 2014Trial
- Recent Advances in mRNA-Based Vaccines Against Several Hepatitis Viruses.Biological procedures online · 2025Review
- The immune microenvironment of cancer of the uterine cervix.Histology and histopathology · 2024Review
- Review
- Review
- Peptide Vaccines as Therapeutic and Prophylactic Agents for Female-Specific Cancers: The Current Landscape.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Development of therapeutic vaccines for the treatment of diseases.Molecular biomedicine · 2022Review
- Therapeutic vaccines for human papillomavirus-related cancer: progress and challenges.Translational cancer research · 2022Article
- Review
- Importance of the Immune Microenvironment in the Spontaneous Regression of Cervical Squamous Intraepithelial Lesions (cSIL) and Implications for Immunotherapy.Journal of clinical medicine · 2022Review
- Effectiveness of combination therapy with ISA101 vaccine for the treatment of human papillomavirus-induced cervical cancer.Frontiers in oncology · 2022Review
- Governing HPV-related carcinoma using vaccines: Bottlenecks and breakthroughs.Frontiers in oncology · 2022Review
- Peptide-Based Nanovaccines in the Treatment of Cervical Cancer: A Review of Recent Advances.International journal of nanomedicine · 2022Review
- ADXS11-001 LM-LLO as specific immunotherapy in cervical cancer.Human vaccines & immunotherapeutics · 2021Article
- Cancer Immunoprevention: Current Status and Future Directions.Archivum immunologiae et therapiae experimentalis · 2021Review
- Robust anti-tumor T cell response with efficient intratumoral infiltration by nanodisc cancer immunotherapy.Advanced therapeutics · 2020Article
- Polyomavirus-driven Merkel cell carcinoma: Prospects for therapeutic vaccine development.Molecular carcinogenesis · 2020Review
- Natural history of human papillomavirus and vaccinations in men: A literature review.Health science reports · 2019Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aim of this study was to investigate the capacity of an HPV16 E6/E7 synthetic overlapping long-peptide vaccine to stimulate the HPV16-specific T-cell response, to enhance the infiltration of HPV16-specific type 1 T cells into the lesions of patients with HPV16+ high-grade cervical squamous intraepithelial lesion (HSIL) and HPV clearance. This was a placebo-controlled randomized phase II study in patients with HPV16-positive HSIL. HPV16-specific T-cell responses were determined pre- and post-vaccination by ELISPOT, proliferation assay and cytokine assays in PBMC and HSIL-infiltrating lymphocytes, and delayed-type hypersensitivity skin tests. Motivational problems of this patient group to postpone treatment of their premalignant lesions affected the inclusion rates and caused the study to stop prematurely. Of the accrued patients, 4 received a placebo and 5 received 1-2 vaccinations. Side effects mainly were flu-like symptoms and injection site reactions. A strong HPV-specific IFNγ-associated T-cell response was detected by ELISPOT in all vaccinated patients. The outcome of the skin tests correlated well with the ELISPOT analysis. The cytokine profile associated with HPV16-specific proliferation varied from robust type 1 to dominant type 2 responses. No conclusions could be drawn on vaccine-enhanced T-cell infiltration of the lesion, and there was no HPV clearance at the time of LEEP excision. Thus, vaccination of HSIL patients results in increased HPV16-specific T-cell immunity. Further development of this type of treatment relies on the ability to motivate patients and in the reduction in the side effects.
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What OpenQuestion holds
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.