Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 14, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Safety of DC cells vaccine targeting HPV16/18 E6/E7 [ Time Frame: Baseline through 90 days after vaccine injection ]
    Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
  • Efficacy of DC Vaccines against HPV E6/E7 [ Time Frame: once per three month ]
    Cytokines, tumor biomarkers, neoantigen-specific T cells would be detected at multiple time points.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
Disease Response [ Time Frame: once per three month ]
1. Detection of protein expression of HPV E6 / E7; 2. Evaluation of CIN phase
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2
Official Title  ICMJE Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Intraepithelial Neoplasia
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: Vaccinated group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lili Ren, Ph.D. +86-755-22942466 ren.lili@szhospital.com
Contact: Fanli Meng, Ph.D. +86-755-22942466 mengfanli2001@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03870113
Other Study ID Numbers  ICMJE ShenzhenPH BTR-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shenzhen People's Hospital
Study Sponsor  ICMJE Shenzhen People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hui Qi, M.D. Shen Zhen People's Hospital
PRS Account Shenzhen People's Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP