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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
Sponsor:
Information provided by (Responsible Party):
Shenzhen People's Hospital

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
Cervical Intraepithelial Neoplasia Biological: Vaccinated group 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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years ≤ 70 years at the time of informed consent
  2. HPV type 16/18 positive
  3. Pathologically confirmed CIN1/2 and no other cervical disease
  4. adequate organ functions.

Exclusion Criteria:

  1. Severe allergy to drugs
  2. Women of child-bearing potential who are pregnant or breast-feeding
  3. Any form of primary immunodeficiency
  4. With serious cardiac, cerebrovascular and primary diseases
  5. With a history of severe mental illness

Information from the National Library of Medicine

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


Contacts
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Contact: Lili Ren, Ph.D. +86-755-22942466 ren.lili@szhospital.com
Contact: Fanli Meng, Ph.D. +86-755-22942466 mengfanli2001@sina.com

Locations
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China, Guangdong
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Contact: Lili Ren, Ph.D.    +86-755-22942466    ren.lili@szhospital.com   
Contact: Fanli Meng, Ph.D.    +86-755-22942466    mengfanli2001@sina.com   
Sponsors and Collaborators
Shenzhen People's Hospital
Investigators
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Study Director: Hui Qi, M.D. Shen Zhen People's Hospital
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Responsible Party: Shenzhen People's Hospital
ClinicalTrials.gov Identifier: NCT03870113    
Other Study ID Numbers: ShenzhenPH BTR-002
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shenzhen People's Hospital:
Cervical Intraepithelial Neoplasia
Human Papillomavirus
Dentritic Vaccine
E6/E7 protein
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type