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

NCT05905354 | Unknown

• 1 other identifier: NEWISH-HPV-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HSIL of Cervix

Outcome Measures

Primary Outcomes (1)

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

  Analysis of immunogenicity data included the level, type, subtype, and time and duration of specific humoral and cellular immune responses in peripheral blood before and after vaccination.

  Week36

Secondary Outcomes (3)

• Adverse Events (AEs)

  End of study

• proportion of patients with HPV virus clearance

  Week 36

• proportion of patients with regression of cervical lesions

  Week 36

Study Arms (1)

lose dose,high dose

EXPERIMENTAL

Four dose groups were set up: dose group 1, a single dose of 2mg, administered at week 0, 4 and 12, three times in total; Dose group 2, a single dose of 6mg, respectively at the 0, 4, 12 weeks, a total of 3 times; Dose group 3, a single dose of 2mg, was given at the 0, 2, 4, 12 weeks, a total of 4 times; Dose group 4, with a single dose of 6mg, was given 4 times at week 0, 2, 4 and 12, respectively. There were 3 subjects in each group. Climb from the low dose group to the high dose group.

Biological: NWRD08

Interventions

NWRD08 BIOLOGICAL

Subjects in dose group 1 and 2 were intramuscularly injected with NWRD08 at week 0, week 4 and week 12 by electric pulse gene delivery instrument, respectively. Subjects in dose group 3 and 4 were intramuscularly injected NWRD08 at week 0, week 2, week 4 and week 12 by electric pulse gene delivery instrument, respectively.

lose dose,high dose

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Received any non-investigational live vaccine within 4 weeks;
• Acute or chronic bleeding or coagulopathy;
• Less than two sites can be used for intramuscular injection;
• Received chemotherapy, molecular targeted therapy, biological immunotherapy, or Chinese patent drugs for cervical lesions within 30 days before or during screening;
• participated in other clinical trials within 30 days prior to screening, or was in the observation period of other clinical trials;
• Continuous (more than 1 week) glucocorticoid therapy (dose equivalent to prednisone \> 10 mg/ day), except hormone replacement therapy and endotracheal administration;
• History of immune deficiency or autoimmune disease (such as rheumatoid joint disease, systemic lupus erythematosus, multiple sclerosis, etc.);

Sponsors & Collaborators

• Newish Technology (Beijing) Co., Ltd.: lead

Study Sites (1)

Heze Municipal Hospital

Heze, Shandong, China

RECRUITING

Study Officials

• Sun Guodong, Master

  Shandong Heze Municipal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Defang, Doctor

CONTACT

(+86)010-87661655; ldf@newishes.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 dose climb

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 15, 2023
• Study Start: March 7, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)