Human papillomavirus infection and cervical intraepithelial neoplasia
Conditions
Interventions
MAD Experiment - Experimental Group:Receive three doses of therapeutic vaccine injections
MAD Experiment - Control Group:None
SAD experiment group:Receive one dose of therapeutic vaccine injection
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Female, aged 18 to 65; 2.persistent positive for HPV16 in the cervix for at least 6 months; 3.cervical pathology diagnosis of chronic mucosal inflammation or CIN1; 4.negative pregnancy test; 5.no sexual activity for 12 months after the start of the trial or agreement to use condoms for contraception during sexual activity; 6.voluntary participation and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Cervical HPV16 negative; 2.combined with other high-risk HPV types except HPV16 positive; 3.cytological examination shows HSIL/ASC-H (high-grade squamous intraepithelial lesion/atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion), AGC (atypical glandular cells), AIS (adenocarcinoma in situ), malignant cells; 4.colposcopy shows cervical high-grade intraepithelial lesion or cancerous manifestations, or cervical pathological diagnosis of high-grade intraepithelial lesion or cancer, or combined with vaginal wall, vulvar intraepithelial lesion or cancer; 5.patients with severe cardiovascular, neurological, mental, endocrine, liver function, hematopoietic system diseases; 6.infected with hepatitis B, hepatitis C, HIV or other immunodeficiency states, or need long-term use of glucocorticoids and immunosuppressants; 7.patients with malignant tumors; 8.pregnancy or lactation; 9.received interferon or antiviral drugs within 3 months before enrollment, or received photodynamic, red card, laser treatment within 1 year before enrollment; 10.received cervical surgery in the past; 11.poor compliance, or expected to be unable to complete the trial and follow-up due to living conditions and other restrictions; 12.in addition to the above, the researcher deems it inappropriate for the patient to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum anti-HPV16 E6 and E7 IgG antibody levels;The level of cellular immune response;Clearance rate of cervical HPV16; | — |
Secondary
| Measure | Time frame |
|---|---|
| The regression rate of cervical lesions; | — |
Countries
China
Contacts
Public ContactLihua Qiu
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed