DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 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:
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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;
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To develop HPV 16/18 E6/E7- pulsed DC vaccines and evaluate the safety and efficacy of DC vaccines;
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The patients are vaccinated with the HPV16/18 E6/E7- pulsed DC vaccines
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To evaluate the safety and efficacy of DC vaccines loaded with HPV 16/18 E6/E7.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vaccinated group Patients 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. |
Biological: Vaccinated group
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.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [Safety] [3 months after the last vaccination injection]
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.
- Immunogenicity of neoantigen-primed DC Vaccines [once per three month]
Immunogenicity of the DC vaccine will be measured to detect changes of neoantigen-specific T cells by flow cytometry.
Secondary Outcome Measures
- Objective Response Rate [once per three month]
Objective Response Rate will be measured by detection of protein expression of HPV E6 / E7and evaluation of CIN phase
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years ≤ 70 years at the time of informed consent
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HPV type 16/18 positive
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Pathologically confirmed CIN1/2 and no other cervical disease
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adequate organ functions.
Exclusion Criteria:
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Severe allergy to drugs
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Women of child-bearing potential who are pregnant or breast-feeding
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Any form of primary immunodeficiency
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With serious cardiac, cerebrovascular and primary diseases
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With a history of severe mental illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shenzhen People's Hospital | Shenzhen | Guangdong | China | 518020 |
Sponsors and Collaborators
- Shenzhen People's Hospital
Investigators
- Study Director: Hui Qi, M.D., Shen Zhen People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ShenzhenPH BTR-002