Clinical trial NCT05905354: Clinical Study of HPV Therapeutic DNA Vaccine (NWRD08) in Patients With Cervical HPV16 and/or HPV18 Positive
Official title: Clinical Study of HPV Therapeutic DNA Vaccine (NWRD08) in Patients With Cervical HPV16 and/or HPV18 Positive
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HSIL of Cervix
Lead sponsor: Newish Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 3+3 dose climb
Primary purpose: TREATMENT

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

Detailed description: The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.The secondary objective was to observe the safety of NWRD08 in cervical patients who were positive for HPV16 and/or HPV18, and to initially explore the efficacy of NWRD08.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. women who have sex;
3. HPV16 and/or 18 DNA and E6E7 mRNA were positive;
4. 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;
5. Cervical tissue specimens/sections should be provided 4 weeks before the first treatment of HISL;
6. Electrocardiogram (ECG) is normal;
7. 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;
8. 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.

Exclusion Criteria:

1. any histopathologically confirmed adenocarcinoma in situ (AIS), high-grade vulvar, vaginal or anal intraepithelial tumors, or invasive cancers;
2. Patients with unsatisfactory colposcope;
3. 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);
4. Positive HPV type 31 or 33 or 45 or 52 or 58;
5. Have received cervical physical therapy;
6. pregnant, breastfeeding, or considering becoming pregnant during the study period;
7. previous history of therapeutic or preventive HPV vaccination;
8. Received any non-investigational inactivated vaccine injection within 2 weeks;
9. Received any non-investigational live vaccine within 4 weeks;
10. Acute or chronic bleeding or coagulopathy;
11. Less than two sites can be used for intramuscular injection;
12. Received chemotherapy, molecular targeted therapy, biological immunotherapy, or Chinese patent drugs for cervical lesions within 30 days before or during screening;
13. participated in other clinical trials within 30 days prior to screening, or was in the observation period of other clinical trials;
14. Continuous (more than 1 week) glucocorticoid therapy (dose equivalent to prednisone \&gt; 10 mg/ day), except hormone replacement therapy and endotracheal administration;
15. History of immune deficiency or autoimmune disease (such as rheumatoid joint disease, systemic lupus erythematosus, multiple sclerosis, etc.);
16. with uncontrolled severe infection;
17. Patients with a history of hepatitis B virus (HBV), hepatitis C virus (HCV) infection or human immunodeficiency virus (HIV) infection or syphilis carriers;
18. Patients with severe other organ dysfunction or cardiopulmonary disease, including myocardial infarction, stroke, congestive heart failure, severe lung disease, metabolic diseases, wound healing abnormalities, ulcers or fractures;
19. Epilepsy accompanied by medication (such as steroids or antiepileptic drugs);
20. Previous or present malignant neoplasms;
21. A history of severe allergies, or a history of allergic diseases, or an allergic constitution, or a severe iodine contrast allergy, meeting any of these criteria;
22. serious mental disorders;
23. A history of drug or alcohol abuse;
24. A pregnant or lactating woman, or a woman of childbearing age who has a positive blood pregnancy test, or a patient of childbearing age and her spouse who is unwilling to take effective contraceptive measures during the clinical study period and within 6 months after the end of treatment;
25. Patients deemed unsuitable for this clinical trial by the investigator.

Primary outcomes:
measure: HPV 16/18 E6E7 specific immune response in peripheral blood after vaccination compared to before vaccination.
timeFrame: Week36
Secondary outcomes:
measure: Adverse Events (AEs)
timeFrame: End of study
measure: proportion of patients with HPV virus clearance
timeFrame: Week 36
measure: proportion of patients with regression of cervical lesions
timeFrame: Week 36
Other outcomes:
Locations:
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
Study officials:
affiliation: Shandong Heze Municipal Hospital
name: Sun Guodong, Master
role: PRINCIPAL_INVESTIGATOR
References: