UnknownNot Applicable

Clinical Study of HPV Therapeutic DNA Vaccine (NWRD08) in Patients With Cervical HPV16 and/or HPV18 Positive

China12 participantsStarted 2022-03-07

Plain-language summary

This is an open-label exploratory clinical study. The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥18 years old;
✓. women who have sex;
✓. HPV16 and/or 18 DNA and E6E7 mRNA were positive;
✓. Patients with highly squamous intraepithelial lesions of the cervix confirmed by histology and cytology, or persistent cervical PV16 and/or 18 infection for more than 12 months;
✓. Cervical tissue specimens/sections should be provided 4 weeks before the first treatment of HISL;
✓. Electrocardiogram (ECG) is normal;
✓. Women of reproductive age must have a negative serum pregnancy test within 1 week prior to the first dose and have agreed to use effective contraception during the study drug use period and within 6 months after the last dose of the study drug. For males, it should be surgical sterilization or consent to effective contraception during the study drug use period and within 6 months after the last study drug administration;
✓. Have fully understood the study and voluntarily signed the ICF, be able to communicate well with the investigator and complete all treatments, examinations and visits required by the study protocol.

✕. any histopathologically confirmed adenocarcinoma in situ (AIS), high-grade vulvar, vaginal or anal intraepithelial tumors, or invasive cancers;
✕. Patients with unsatisfactory colposcope;
✕. Patients who were satisfied with colposcopy but not satisfied with ECC (patients who were positive for HPV18 or had abnormal adenocytes on cervical cytology but satisfied with colposcopy should undergo ECC examination);
✕. Positive HPV type 31 or 33 or 45 or 52 or 58;
✕. Have received cervical physical therapy;
✕. pregnant, breastfeeding, or considering becoming pregnant during the study period;
✕. previous history of therapeutic or preventive HPV vaccination;
✕. Received any non-investigational inactivated vaccine injection within 2 weeks;

HPV 16/18 E6E7 specific immune response in peripheral blood after vaccination compared to before vaccination.

Timeframe: Week36

NCT IDNCT05905354

SponsorNewish Technology (Beijing) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-30

Liu Defang, Doctor

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥18 years old;
✓. women who have sex;
✓. HPV16 and/or 18 DNA and E6E7 mRNA were positive;
✓. Patients with highly squamous intraepithelial lesions of the cervix confirmed by histology and cytology, or persistent cervical PV16 and/or 18 infection for more than 12 months;
✓. Cervical tissue specimens/sections should be provided 4 weeks before the first treatment of HISL;
✓. Electrocardiogram (ECG) is normal;
✓. Women of reproductive age must have a negative serum pregnancy test within 1 week prior to the first dose and have agreed to use effective contraception during the study drug use period and within 6 months after the last dose of the study drug. For males, it should be surgical sterilization or consent to effective contraception during the study drug use period and within 6 months after the last study drug administration;
✓. Have fully understood the study and voluntarily signed the ICF, be able to communicate well with the investigator and complete all treatments, examinations and visits required by the study protocol.

✕. any histopathologically confirmed adenocarcinoma in situ (AIS), high-grade vulvar, vaginal or anal intraepithelial tumors, or invasive cancers;
✕. Patients with unsatisfactory colposcope;
✕. Patients who were satisfied with colposcopy but not satisfied with ECC (patients who were positive for HPV18 or had abnormal adenocytes on cervical cytology but satisfied with colposcopy should undergo ECC examination);
✕. Positive HPV type 31 or 33 or 45 or 52 or 58;
✕. Have received cervical physical therapy;
✕. pregnant, breastfeeding, or considering becoming pregnant during the study period;
✕. previous history of therapeutic or preventive HPV vaccination;
✕. Received any non-investigational inactivated vaccine injection within 2 weeks;