Status:
UNKNOWN
DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2
Lead Sponsor:
Shenzhen People's Hospital
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
To establish therapeutic dendritic cell (DC) vaccines targeting HPV 16/18 E6/E7 protein to block the progression of CIN1/CIN2 to cervical cancer and evaluate the safety and efficacy of the vaccines.
Detailed Description
Cervical cancer is the second most common cause of cancer-related deaths among women worldwide with 10000 new cases each year in China. The high-risk human papillomavirus (HPV) was the major cause of ...
Eligibility Criteria
Inclusion
- Age ≥18 years ≤ 70 years at the time of informed consent
- HPV type 16/18 positive
- Pathologically confirmed CIN1/2 and no other cervical disease
- adequate organ functions.
Exclusion
- Severe allergy to drugs
- Women of child-bearing potential who are pregnant or breast-feeding
- Any form of primary immunodeficiency
- With serious cardiac, cerebrovascular and primary diseases
- With a history of severe mental illness
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03870113
Start Date
April 1 2019
End Date
December 30 2022
Last Update
March 14 2019
Active Locations (1)
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1
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020