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

NCT07077980 | Not Yet Recruiting

• 1 other identifier: YingZhou 2025-3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The activity of T cell

  The T cell activity exceeds 95%.

  one month

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cervical cancer patients diagnosed with HPV16 or HPV18 infection

You may qualify if:

• 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.
• Cervical carcinoma caused by HPV16 or HPV18 infection.
• The pathological stage is from IB1 to IV, and informed consent is obtained.
• If the tumor tissue of patients with stage IB1 is not obvious, samples can be taken or not taken without affecting subsequent pathological examinations.

You may not qualify if:

• Patients with other malignancies
• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provincal Hospital

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ying Zhou, MD

  The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

  STUDY CHAIR

Central Study Contacts

Ying Zhou, MD

CONTACT

+8613865901025; caddiezy@ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2033
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)