This is an open-label exploratory clinical study. The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Heze Municipal Hospital
Heze, Shandong, China
RECRUITINGHPV 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.
Time frame: Week36
Adverse Events (AEs)
Adverse Events (AEs), adverse events according to type, frequency, severity \[according to the Classification Scale of Adverse Events in Clinical Trials for Preventive Vaccines issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration in 2019\], occurrence time, and severity. And whether it's related to treatment.
Time frame: End of study
proportion of patients with HPV virus clearance
Proportion of patients with negative HPV16/18 DNA and E6E7 mRNA.
Time frame: Week 36
proportion of patients with regression of cervical lesions
1. HSIL patients 36 weeks group / 18 DNA and E6E7 mRNA overcast and histological ratio dropped below CIN1 and patients; 2. HSIL patients 36 weeks group / 18 DNA and E6E7 mRNA overcast and histological the proportion of patients with squamous intraepithelial lesions; 3. LSIL patients 18 DNA and 36 weeks group/E6E7 mRNA overcast and cytology squamous intraepithelial lesions;
Time frame: Week 36
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