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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(s)
Youn Jin ChoiSoo Young HurTae-Jin KimSung Ran HongJae Kwan LeeChi-Heum ChoKi Seok ParkJung Won WooYoung Chul SungYou Suk SuhJong Sup Park
Keimyung Author(s)
Cho, Chi Heum
Department
Dept. of Obstetrics & Gynecology (산부인과학)
Journal Title
Clinical cancer research : an official journal of the American Association for Cancer Research
Issued Date
2020
Volume
26
Issue
7
Abstract
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 IFNγ 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 IFNγ 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.
Keimyung Author(s)(Kor)
조치흠
Publisher
School of Medicine (의과대학)
Citation
Youn Jin Choi et al. (2020). A Phase II, Prospective, Randomized, Multicenter, Open-Label Study of GX-188E, an HPV DNA Vaccine, in Patients with Cervical Intraepithelial Neoplasia 3. Clinical cancer research : an official journal of the American Association for Cancer Research, 26(7), 1616–1623. doi: 10.1158/1078-0432.CCR-19-1513
Type
Article
ISSN
1557-3265
Source
https://clincancerres.aacrjournals.org/content/26/7/1616.long
DOI
10.1158/1078-0432.CCR-19-1513
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43018
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Obstetrics & Gynecology (산부인과학)
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