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.

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. - Vvax001 cancer vaccine in (pre) malignant cervical lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43094

Enrollment

Registered

2016-07-04

Start date

2017-01-13

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical neoplasia/cervical cancer

Interventions

Patients will receive three intramuscular immunizations with a 3-week interval. Patient evaluation will be performed before, immunization including history, physical examination, full blood count, u

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the immunogenicity of Vvax001. By monitoring HPV-16 E6,7-specific T-cell immune responses, the optimal dose inducing the highest immune responses will be determined.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)