Trial reportCancer immunology, immunotherapy : CII2004
Phase I/II trial of immunogenicity of a human papillomavirus (HPV) type 16 E7 protein-based vaccine in women with oncogenic HPV-positive cervical intraepithelial neoplasia.
Trial report in Cancer immunology, immunotherapy : CII, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
41 citing papers in PubMed, 1 synthesis or guideline pooled it, 109 citations in OpenAlex.
- Effectiveness and Safety of Therapeutic Vaccines for Precancerous Cervical Lesions: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2022Pooled it
- Traditional Chinese Medicine Erhuang Suppository for Treatment of Persistent High-risk Human Papillomavirus Infection and Its Impact on Transcriptome of Uterine Cervix.Current medical science · 2024Trial
- The current landscape of therapeutic vaccination approaches for treatment of HPV-dependent malignancies.NPJ vaccines · 2026Review
- Immunotherapy in Cervical and Endometrial Cancer: Current Landscape and Future Directions.Life (Basel, Switzerland) · 2024Review
- HPV pathogenesis, various types of vaccines, safety concern, prophylactic and therapeutic applications to control cervical cancer, and future perspective.Virusdisease · 2023Review
- Dissolving Microneedle Delivery of a Prophylactic HPV Vaccine.Biomacromolecules · 2022Article
- Therapeutic DNA Vaccines against HPV-Related Malignancies: Promising Leads from Clinical Trials.Viruses · 2022Review
- Murine HPV16 E7-expressing transgenic skin effectively emulates the cellular and molecular features of human high-grade squamous intraepithelial lesions.Papillomavirus research (Amsterdam, Netherlands) · 2018Review
- Targeted immunotherapy of high-grade cervical intra-epithelial neoplasia: Expectations from clinical trials.Molecular and clinical oncology · 2018Article
- Advances in Designing and Developing Vaccines, Drugs and Therapeutic Approaches to Counter Human Papilloma Virus.Frontiers in immunology · 2018Review
- Targeting immune response with therapeutic vaccines in premalignant lesions and cervical cancer: hope or reality from clinical studies.Expert review of vaccines · 2016Review
- Translational fusion and redirection to thylakoid lumen as strategies to enhance accumulation of human papillomavirus E7 antigen in tobacco chloroplasts.Molecular biotechnology · 2014Article
- Therapeutic Vaccine Strategies against Human Papillomavirus.Vaccines · 2014Review
- Cervical Cancer: Development of Targeted Therapies Beyond Molecular Pathogenesis.Current obstetrics and gynecology reports · 2014Article
- Prevention and Inhibition of TC-1 Cell Growth in Tumor Bearing Mice by HPV16 E7 Protein in Fusion with Shiga Toxin B-Subunit from shigella dysenteriae.Cell journal · 2013Article
- Emerging human papillomavirus vaccines.Expert opinion on emerging drugs · 2012Review
- Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses.Science translational medicine · 2012Article
- Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy.Oncoimmunology · 2012Article
- Preventive and Therapeutic Vaccines against Human Papillomaviruses Associated Cervical Cancers.Iranian journal of basic medical sciences · 2012Article
- Natural killer cells: role in local tumor growth and metastasis.Biologics : targets & therapy · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeInfection with oncogenic human papillomavirus (HPV) and HPV-16 in particular is a leading cause of anogenital neoplasia. High-grade intraepithelial lesions require treatment because of their potential to progress to invasive cancer. Numerous preclinical studies have demonstrated the therapeutic potential of E7-directed vaccination strategies in mice tumour models. In the present study, we tested the immunogenicity of a fusion protein (PD-E7) comprising a mutated HPV-16 E7 linked to the first 108 amino acids of Haemophilus influenzae protein D, formulated in the GlaxoSmithKline Biologicals adjuvant AS02B, in patients bearing oncogenic HPV-positive cervical intraepithelial neoplasia (CIN).
methodsSeven patients, five with a CIN3 and two with a CIN1, received three intramuscular injections of adjuvanted PD-E7 at 2-week intervals. Three additional CIN1 patients received a placebo. CIN3 patients underwent conization 8 weeks postvaccination. Cytokine flow cytometry and ELISA were used to monitor antigen-specific cellular and antibody responses from blood taken before and after vaccine or placebo injection.
resultsSome patients had preexisting systemic IFN-gamma CD4+ (1/10) and CD8+ (5/10) responses to PD-E7. Vaccination, not placebo injection, elicited systemic specific immune responses in the majority of the patients. Five vaccinated patients (71%) showed significantly increased IFN-gamma CD8+ cell responses upon PD-E7 stimulation. Two responding patients generated long-term T-cell immunity toward the vaccine antigen and E7 as well as a weak H. influenzae protein D (PD)-directed CD4+ response. All the vaccinated patients, but not the placebo, made significant E7- and PD-specific IgG.
conclusionsThe encouraging results obtained from this study performed on a limited number of subjects justify further analysis of the efficacy of the PD-E7/AS02B vaccine in CIN patients.
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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.