Clinical trial · Interventional
DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2
Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein
NCT03870113CI-TRIAL-00037598unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaccinated group | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccinated 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.
- interventionNames
- Biological: Vaccinated group
Primary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety]
- timeFrame
- 3 months after the last vaccination injection
- description
- 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.
- measure
- Immunogenicity of neoantigen-primed DC Vaccines
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.