Clinical trial · Interventional
Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia
A Phase I Efficacy and Safety Study of HPV16-specific Therapeutic DNA-vaccinia Vaccination in Combination With Topical Imiquimod, in Patients With HPV16+ High Grade Cervical Dysplasia (CIN3)
NCT00788164CI-TRIAL-00069228completedPhase 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)
RATIONALE: Vaccines made from DNA or a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the cervix may be an effective treatment for cervical intraepithelial neoplasia. Giving vaccine therapy together with imiquimod may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy and to see how well it works when given with or without imiquimod in treating patients with grade 3 cervical intraepithelial neoplasia.
Conditions
Conditions (4)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HPV Disease | — | UNRESOLVED | — |
| Human Papilomavirus | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imiquimod | Drug | Imiquimod | ALIAS |
| pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine | Biological | — | UNRESOLVED |
| TA-HPV | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Groups 1-3
- description
- Patients receive pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine intramuscularly (IM) on days 1 and 29 and TA-HPV vaccine IM on day 57.
- interventionNames
- Biological: TA-HPV
- Biological: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine
- type
- EXPERIMENTAL
- label
- Group 4
- description
- Patients receive topical imiquimod on days 1, 29, and 57.
- interventionNames
- Drug: imiquimod
- type
- EXPERIMENTAL
- label
- Group 5
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Colposcopically and biopsy confirmed grade 3 cervical intraepithelial neoplasia * Human papillomavirus (HPV) 16-positive disease by PCR * Measurable disease after diagnostic biopsy * No concurrent adenocarcinoma in situ of the cervix PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use an effective form of contraception during study treatment * Immunocompetent * No concurrent malignancy, except for nonmelanoma skin lesions * No serious concurrent disorder, including any of the following: * Active systemic infection * Autoimmune disease * Proven or suspected immunosuppressive disorder * Major medical illnesses of the cardiovascular or respiratory system * No evidence or history of cardiac disease, including any of the following: * Congestive heart failure * Symptomatic arrhythmia not controlled by medication * Unstable angina * History of acute myocardial infarction or cerebrovascular accident within the past 6 months * No history of severe allergy including eczema or other exfoliative skin disorder * No active eczema within the past 12 months * No concurrent skin conditions, including any of the following: * Burns * Traumatic or pruritic skin conditions * Open wounds * Unhealed surgical scars * Patients and their close social, sexual, or domestic contacts may not have any of the following active skin diseases: * Psoriasis * Lichen planus * Sever acneiform rash * Impetigo * Varicella zoster * Sepsis * No close social contact with children under 5 years old * No close social or domestic contact with a pregnant woman * No HIV seropositivity * No allergy to eggs PRIOR CONCURRENT THERAPY: * No previous vaccination with vaccinia * No immunosuppressive medication (i.e., steroid therapy or other immunosuppressive/immunomodulating drugs \[e.g., cyclosporine\]) within the past 2 months * No investigational agent(s) within the past 6 months * No concurrent participation in another experimental protocol
References
Publications (3)
- RESULTMaldonado L, Teague JE, Morrow MP, Jotova I, Wu TC, Wang C, Desmarais C, Boyer JD, Tycko B, Robins HS, Clark RA, Trimble CL. Intramuscular therapeutic vaccination targeting HPV16 induces T cell responses that localize in mucosal lesions. Sci Transl Med. 2014 Jan 29;6(221):221ra13. doi: 10.1126/scitranslmed.3007323. PMID 24477000
- DERIVEDPeng S, Ferrall L, Gaillard S, Wang C, Chi WY, Huang CH, Roden RBS, Wu TC, Chang YN, Hung CF. Development of DNA Vaccine Targeting E6 and E7 Proteins of Human Papillomavirus 16 (HPV16) and HPV18 for Immunotherapy in Combination with Recombinant Vaccinia Boost and PD-1 Antibody. mBio. 2021 Jan 19;12(1):e03224-20. doi: 10.1128/mBio.03224-20. PMID 33468698
- DERIVEDSun YY, Peng S, Han L, Qiu J, Song L, Tsai Y, Yang B, Roden RB, Trimble CL, Hung CF, Wu TC. Local HPV Recombinant Vaccinia Boost Following Priming with an HPV DNA Vaccine Enhances Local HPV-Specific CD8+ T-cell-Mediated Tumor Control in the Genital Tract. Clin Cancer Res. 2016 Feb 1;22(3):657-69. doi: 10.1158/1078-0432.CCR-15-0234. Epub 2015 Sep 29. PMID 26420854