Discovery of HPV T Cell Epitopes and Development of Multi-epitope Vaccines

NCT ID: NCT07077980

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2033-09-01

Brief Summary

Based on the trend that the incidence and mortality of cervical carcinoma among female cancers worldwide are increasing year by year, the investigators aim to develop a multi-epitope therapeutic vaccine capable of simultaneously activating humoral and cellular immune responses, which is achieved by fusing multiple T-cell epitope immunostimulatory proteins. To obtain information on functional T-cell epitopes to be included in the vaccine, the investigators conducted research starting from clinical cases. By collecting peripheral blood and cancerous tissues from clinical patients, the investigators isolated reactive T-cells and screened for information on T-cell epitopes of HPV antigens.

Conditions

Cervical Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Females aged between 18 and 65 who can receive standard treatment, including those who only undergo surgery or those who receive radiotherapy and chemotherapy after surgery.

2. Cervical carcinoma caused by HPV16 or HPV18 infection.

3. The pathological stage is from IB1 to IV, and informed consent is obtained.

4. If the tumor tissue of patients with stage IB1 is not obvious, samples can be taken or not taken without affecting subsequent pathological examinations.

Exclusion Criteria

1. Patients with other malignancies

2. Patients with any uncontrolled systemic disease, including active infection, uncontrolled hypertension, diabetes mellitus, unstable angina and congestive heart failure, myocardial infarction (1 year) before starting treatment, severe arrhythmia requiring medical treatment, coagulation abnormalities, liver or kidney or metabolic disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Zhou, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Locations

Anhui Provincal Hospital

Hefei, Anhui, China

Countries

China

Central Contacts

Ying Zhou, MD

Role: CONTACT

caddiezy@ustc.edu.cn

+8613865901025

Facility Contacts

Ying Zhou, MD

Role: primary

caddiezy@ustc.edu.cn

+8613865901025

Other Identifiers

YingZhou 2025-3

Identifier Type: -

Identifier Source: org_study_id