Clinical trial · Interventional
Vvax001 Cancer Vaccine in Premalignant Cervical Lesions - Phase II
A Phase II Study to Determine the Efficacy and Safety of Vvax001, a Therapeutic Semliki Forest Virus Based Cancer Vaccine, in Patients With HPV-16 Induced Grade 3 Cervical Intraepithelial Neoplasia
- 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 is an open label phase II study in patients with newly diagnosed human papilloma virus type 16 (HPV16) induced cervical intraepithelial neoplasia grade 3 (CIN3). Patients will be treated with three doses of Vvax001 immunization with an interval of 3 weeks between each immunization to induce histopathological regression and HPV clearance. Regression of CIN3 lesions will be monitored using colposcopy in week 9, week 17 and week 25. When complete regression of the CIN3 lesion is observed by colposcopy, a biopsy will be taken in week 25 to confirm regression histologically. A positive histologic regression is defined as a reduction from CIN3 to CIN1 or no dysplasia. Patients with a complete regression will not undergo the standard-of-care loop excision of the transformation zone (LETZ) and will be followed-up after the study by cytology at 3, 6 and 12 months. If complete regression has not occurred by 25 weeks, a standard-of-care LETZ will be performed.
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 Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervical Intraepithelial Neoplasia Grade 3 | — | UNRESOLVED | — |
| CIN3 | — | UNRESOLVED | — |
| HPV 16 Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vvax001 therapeutic cancer vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV16+ CIN3
- description
- Patients with histological proven HPV16-positive cervical intraepithelial neoplasia grade 3.
- interventionNames
- Biological: Vvax001 therapeutic cancer vaccine
Primary outcomes (1)
- measure
- Clinical efficacy of Vvax001
- timeFrame
- At week 25 (19 weeks after the last immunization)
- description
- Clinical efficacy is determined by a pathological regression of the premalignant CIN3 lesion in pre- versus post-treatment tissue samples. A positive histologic regression is defined as a reduction from CIN3 to CIN1, or a reduction from CIN3 to no dysplasia.
Secondary outcomes (3)
- measure
- Immunogenicity of Vvax001
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed HPV16-positive CIN3. * Age of 18 years and older. * Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study. * Written informed consent according to local guidelines. Exclusion Criteria: * PAP5 lesions. * Previously undergone treatment for CIN lesions. * Adenocarcinoma in situ within CIN3 lesion. * History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the study) of high dose immunosuppressive therapy. * History of a malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the cervical cancer type. * Participation in a study with another investigational drug within 30 days prior to the enrolment in this study. * Clinically significant findings as judged by the Investigator on screening/study entry including those from the Biochemistry, Hematology and urinalysis performed at baseline. * Any condition that in the opinion of the investigator could interfere with the conduct of the study. * Pregnancy.
References
Publications (0)
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