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

Southern University of Science and Technology

Status and phase: Unknown; Phase 1

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Biological: Vaccinated group

Study type: Interventional

Funder types: Other

Identifiers

NCT03870113

ShenzhenPH BTR-002

Details and patient eligibility

About

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 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Vaccinated group

Experimental group

Description:

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.

Treatment:

Biological: Vaccinated group