DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2

Overview

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.

Full Title of Study: “Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shenzhen People’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hui Qi, M.D., Study Director, Shen Zhen People’s Hospital
  • Overall Contact(s)
    • Lili Ren, Ph.D., +86-755-22942466, ren.lili@szhospital.com

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