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Basic Characteristics of Mutations
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Mutation Site
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T178G |
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Mutation Site Sentence
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We also found that D25E (T178G), V83L (G350T), and N29S (A647G) were negatively associated with histopathologic regression at V8 (Table 2). |
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Mutation Level
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Nucleotide level |
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Mutation Type
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Nonsynonymous substitution |
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Gene/Protein/Region
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E6 |
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Standardized Encoding Gene
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E6
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Genotype/Subtype
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HPV16 |
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Viral Reference
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AAL96630
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Functional Impact and Mechanisms
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Disease
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Cervical Intraepithelial Neoplasia
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Immune
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- |
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Target Gene
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-
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Clinical and Epidemiological Correlations
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Clinical Information
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Y |
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Treatment
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- |
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Location
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Korea |
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Literature Information
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PMID
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31727676
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Title
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A Phase II, Prospective, Randomized, Multicenter, Open-Label Study of GX-188E, an HPV DNA Vaccine, in Patients with Cervical Intraepithelial Neoplasia 3
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Author
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Choi YJ,Hur SY,Kim TJ,Hong SR,Lee JK,Cho CH,Park KS,Woo JW,Sung YC,Suh YS,Park JS
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Journal
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Clinical cancer research : an official journal of the American Association for Cancer Research
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Journal Info
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2020 Apr 1;26(7):1616-1623
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Abstract
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PURPOSE: To determine the efficacy of the therapeutic DNA vaccine GX-188E for inducing regression of cervical intraepithelial neoplasia (CIN) 3. PATIENTS AND METHODS: We conducted a prospective, randomized, multicenter, open-label, phase II clinical trial of GX-188E in CIN3 patients positive for human papillomavirus (HPV) type 16/18. The primary endpoint was to determine the histopathologic regression to =CIN1 at visit seven (V7; 20 weeks after the first GX-188E injection), and an extension study was pursued until visit 8 (V8; 36 weeks after the first GX-188E injection). HPV-sequencing analysis and an ex vivo IFNgamma ELISpot assay were performed using the collected cervical biopsy and blood samples from patients. RESULTS: In total, 72 patients were enrolled and underwent randomization. Of them, 64 patients were included in per-protocol analysis (V7) and 52 in extension analysis (V8). Our data showed 52% (33/64) of patients at V7 and 67% (35/52) of patients at V8 presented histopathologic regression after receiving the GX-188E injection. We found that 73% (V7) and 77% (V8) of the patients with histologic regression showed HPV clearance. HPV clearance and histopathologic regression were significantly associated at V7 and at V8. Compared with the measurements at V1 (baseline), the patients at V8 with HPV clearance showed significantly higher fold changes in their IFNgamma ELISpot responses compared with those without HPV clearance. The HPV sequence analysis revealed that the HPV type 16 E6/E7 variants D25E, V83L, and N29S were inversely associated with histopathologic regression at V8. CONCLUSIONS: GX-188E is an effective therapeutic vaccine against a cohort containing only CIN3 patients.
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Sequence Data
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-
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