DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03870113|
Recruitment Status : Not yet recruiting
First Posted : March 11, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia||Biological: Vaccinated group||Phase 1|
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.
- 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;
- To develop HPV 16/18 E6/E7- pulsed DC vaccines and evaluate the safety and efficacy of DC vaccines;
- The patients are vaccinated with the HPV16/18 E6/E7- pulsed DC vaccines
- To evaluate the safety and efficacy of DC vaccines loaded with HPV 16/18 E6/E7.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||December 30, 2022|
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.
- Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: 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 [ Time Frame: once per three month ]Immunogenicity of the DC vaccine will be measured to detect changes of neoantigen-specific T cells by flow cytometry.
- Objective Response Rate [ Time Frame: once per three month ]Objective Response Rate will be measured by detection of protein expression of HPV E6 / E7and evaluation of CIN phase
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870113
|Contact: Lili Ren, Ph.D.||+email@example.com|
|Contact: Fanli Meng, Ph.D.||+firstname.lastname@example.org|
|Study Director:||Hui Qi, M.D.||Shen Zhen People's Hospital|