Clinical trial NCT03870113: DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2
Official title: Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Cervical Intraepithelial Neoplasia
Human Papillomavirus
Dentritic Vaccine
E6/E7 protein
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: 3 months after the last vaccination injection
measure: Immunogenicity of neoantigen-primed DC Vaccines
timeFrame: once per three month
Secondary outcomes:
measure: Objective Response Rate
timeFrame: once per three month
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: Shen Zhen People's Hospital
name: Hui Qi, M.D.
role: STUDY_DIRECTOR
References: