DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2
Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMarch 14, 2019
March 1, 2019
3 years
March 8, 2019
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety]
Safety of personalized neoantigen vaccine will be measured by the number of subjects experiencing each type of adverse event. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
3 months after the last vaccination injection
Immunogenicity of neoantigen-primed DC Vaccines
Immunogenicity of the DC vaccine will be measured to detect changes of neoantigen-specific T cells by flow cytometry.
once per three month
Secondary Outcomes (1)
Objective Response Rate
once per three month
Study Arms (1)
Vaccinated group
EXPERIMENTALPatients will be vaccinated with autologous mature dendritic cells-loaded with HPV 16/18 E6/E7, DC vaccine will be injected into the adjacent lymph-node 6 times, once a week.
Interventions
Develop highly reactive DC vaccines targeting HPV 16/18 E6/ E7 protein and DC vaccine would be injected to patients once a week, six doses in total.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hui Qi, M.D.
Shen Zhen People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2019
First Posted
March 11, 2019
Study Start
April 1, 2019
Primary Completion
March 31, 2022
Study Completion
December 30, 2022
Last Updated
March 14, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share