Immune modulating effects and safety of Vvax001, a therapeutic Semliki Forest Virus based cancer vaccine, in patients with a history of (pre) malignant cervical lesions.

Completed

Conditions: cervical neoplasia/cervical cancer
10019815
10038594

Registration Number: NL-OMON43094

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Patients with a history of cervical intraepithelial neoplasia (CIN) II and III and patients with a history of cervical cancer, both minimally 12 weeks after completion of treatment.

Exclusion Criteria

- Prior treatment with immunotherapeutic agents against HPV
- 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 second 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
- Any condition that in the opinion of the investigator could interfere with the conduct of the study
- Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the immunogenicity of Vvax001. By monitoring HPV-16<br /><br>E6,7-specific T-cell immune responses, the optimal dose inducing the highest<br /><br>immune responses will be determined.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameters are side effects/ adverse events related to Vvax001.<br /><br>Toxicity will be graded according to the NCI Common Terminology Criteria for<br /><br>Adverse Events (CTCAE) Version 4.0.<br /><br><br /><br>The injection sites will be screened for local transformation by means of<br /><br>inspection and palpation. If indicated, imaging (e.g. ultrasound) and/or biopsy<br /><br>will be performed. Screening of the injection sites will be performed during<br /><br>visit 3, 5 and 6.</p><br>