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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03870113
• Other study ID #: ShenzhenPH BTR-002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2019
• Source: Shenzhen People's Hospital
• Contact: Lili Ren, Ph.D.
• Phone: +86-755-22942466
• Email: ren.lili[@]szhospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety]	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.	3 months after the last vaccination injection
Primary	Immunogenicity of neoantigen-primed DC Vaccines	Immunogenicity of the DC vaccine will be measured to detect changes of neoantigen-specific T cells by flow cytometry.	once per three month
Secondary	Objective Response Rate	Objective Response Rate will be measured by detection of protein expression of HPV E6 / E7and evaluation of CIN phase	once per three month