Clinical trial · Interventional
Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
NCT00988559CI-TRIAL-00033684completedPhase 1Results postedClinicalTrials.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)
This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.
Conditions
Conditions (2)
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 (CIN 2/3) | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.85 |
| HPV16 Positive | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA vaccination | Biological | — | UNRESOLVED |
| Gene gun vaccine | Device | — | UNRESOLVED |
| imiquimod | Drug | Imiquimod | ALIAS |
| intra-lesional vaccine administration | Biological | — | UNRESOLVED |
| intramuscular vaccination | Biological | — | UNRESOLVED |
| therapeutic resection of the lesion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- PMED Delivery - groups 1 and 2
- description
- Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
- interventionNames
- Biological: DNA vaccination
- Device: Gene gun vaccine
- Procedure: therapeutic resection of the lesion
- type
- EXPERIMENTAL
- label
- IM injections - groups 5 and 6
- description
- Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.
- interventionNames
- Biological: DNA vaccination
- Biological: intramuscular vaccination
- Procedure: therapeutic resection of the lesion
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with high grade cervical intraepithelial lesions (CIN2/3) * patients whose lesions are HPV16+ * patients who are age 18 or older * patients who are able to give informed consent * patients who are immunocompetent * patients who are not pregnant, committed to using adequate contraception if of childbearing age * patients who have a minimum hemoglobin level of 9 Exclusion Criteria: * Patients with cytologic evidence of glandular dysplasia * Patients with cytologic evidence of adenocarcinoma in situ * Patients who are pregnant * Patients with an active autoimmune disease * Patients who are taking immunosuppressive medication * Patients with concurrent malignancy except for nonmelanoma skin lesions * Patients who have an allergy to gold. * Patients with any evidence of damaged skin, or moles, scars, tattoos or marks at the proposed site(s) of administration that might interfere with the interpretation of local skin reactions. * History or evidence of a physician-diagnosed chronic or recurrent inflammatory skin disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) at the proposed site of administration in the past 5 years. * Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, SLE, and Sjogren's syndrome, sarcoidosis. Asthma or COPD that does not require systemic corticosteroids or routine use of inhaled steroids is acceptable * Patients who have received prior chrysotherapy (administration of gold salts to treat rheumatoid arthritis). * Patients with a history of arterial or venous thrombosis * Patients with non-healed wounds. * Patients with a history of keloid formation ( ID delivery group only) * Patients with a history of hepatitis B with persistent infection.
References
Publications (0)
Data not yet available
No reference posted for this study.