Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Communicable Diseases

Papillomavirus Infections

Papilloma

Virus Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

Colposcopy performed to women with High risk HPV positive ,negative for intraepithelial lesions or malignancy cytology

Colposcopy performed to women with HPV 16/18 positive ,negative for intraepithelial lesions or malignancy cytology

Colposcopy

Abnormal cervical cytology was the most common reason for women being referred to the colposcopy unit. We prospectively included the women with negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive High RiskHPV test other than HPV 16 or HPV 18. Comparing the immediate colposcopy findings among women with High Risk HPV other than HVPV16/18 and negative cytology and determine positive predictive values for CIN2+ of other high risk HPV genotypes

prospective cohort study comparing the immediate colposcopy findings among women with HrHPV other than HVPV16/18 and negative cytology

outcomes assessor blind to clinical data and cytology results

Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology

Immediate Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology

Pathologic diagnosis of cervical dysplasia

Bezmialem Vakif University

Assoc. Prof.

Rare Diseases

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Vaccines

Patients will be assigned to three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD08 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD08 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.

DNA plasmid delivered via IM injection + electroporation using TERESA device

NWRD08 administered by electroporation

Fang Jiang, M.D.

Yang Xiang, M.D.

This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL.

This study is divided into three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD08 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD08 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.

After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration. Colposcopy and biopsy were performed at week 12, if HSIL was identified, loop electro-surgical excisional procedure (LEEP) or cold Knife conization (CKC) will be performed when necessary. The subjects were then followed up at week 36 and all adverse events shall revert to level I or all adverse events shall be clinically stable (whichever is later achieved).

NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL

Phase I Safety and Tolerability Study of NWRD08 in HPV-16 and/or HPV-18 Related Cervical High-grade Squamous Intraepithelial Lesion (HSIL) Patients

all IPD that underlie results in a publication

All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events). The grade of injection-site AEs will be determined on the basis of the Guidelines for Adverse Event Classification Standards for Clinical Trials of Preventive Vaccines (2019) issued by the National Medical Products Administration.

t would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 28 days of the last dosing will be classified as DLT during dosing climb.

Immunologic reactogenicity by measuring HPV16/18 E6/E7 specific T cell response (IFN-γ ELISPOT) and anti-HPV16/18 E6/E7antibodies (ELISA) in blood samples.

Number of subjects with virologically-proven clearance of HPV 16 or 18 and number of subjects with histopathological regression of cervical lesions to CIN 1 or normal.

The recommended phase II dose (RP2D) was selected on the basis of tolerability during the safety expansion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology	NCT04369339	Human Papilloma...	Colposcopy	18 Years - 65 Years	Bezmialem Vakif University
Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology	NCT04369339	Human Papilloma...	Colposcopy	18 Years - 65 Years	Bezmialem Vakif University
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL	NCT06276101	High-grade Squa...	NWRD08 administ...	18 Years - 60 Years	Newish Technology (Beijing) Co., Ltd.
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL	NCT06276101	High-grade Squa...	NWRD08 administ...	18 Years - 60 Years	Newish Technology (Beijing) Co., Ltd.
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL	NCT06276101	High-grade Squa...	NWRD08 administ...	18 Years - 60 Years	Newish Technology (Beijing) Co., Ltd.
Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology	NCT04369339	Human Papilloma...	Colposcopy	18 Years - 65 Years	Bezmialem Vakif University

Spots Global Cancer Trial Database for hpv18

Every month we try and update this database with for hpv18 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hpv18

Every month we try and update this database with for hpv18 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hpv18 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.