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.
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 cervical cancer. The oncoproteins E6 and E7 encoded by HPV16 and 18, are consistently expressed in HPV-associated Cervical cancer and are responsible for the cervical cancer malignant progression. Targeting the E6/E7 proteins could be very helpful to regress the CIN 1/2 and block the tumorigenesis. By this research, we aim to establish the HPV16/18 E6/E7 peptide library which could induce the strong anti-virus immune response and to vaccinate the CIN 1/2 patients with dendritic cell vaccines loaded HPV 16/18 E6/E7 epitopes. Including: 1. To create an effective HPV 16/18 E6/E7 antigen peptide library using NetMHCspan software based on the MHC-I subtype of the Chinese population and screen E6/E7protein peptides with high binding affinity to MHC molecules; 2. To develop HPV 16/18 E6/E7- pulsed DC vaccines and evaluate the safety and efficacy of DC vaccines; 3. The patients are vaccinated with the HPV16/18 E6/E7- pulsed DC vaccines 4. To evaluate the safety and efficacy of DC vaccines loaded with HPV 16/18 E6/E7.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
Shenzhen People's Hospital
Shenzhen, Guangdong, China
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.
Time frame: 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.
Time frame: once per three month
Objective Response Rate
Objective Response Rate will be measured by detection of protein expression of HPV E6 / E7and evaluation of CIN phase
Time frame: once per three month
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