cervical neoplasia / cervical cancer
Conditions
Interventions
and liver function tests. Besides, a pregnancy test will be taken before each 
Patients will receive three immunizations, with an interval of 3 weeks between 
each immunization. Each vaccination will be given as two injections
1 
injection in each leg. The injections will be administered intramuscularly in 
the upper legs, preferably in the m. vastus lateralis. Patient evaluation will 
be performed before immunization and during the first follow-up visit (week 7) 
including history, physical examination, full blood count, urea, electrolytes 
vaccination. Participants may directly leave the study site after injection of 
Vvax001. Participants will be contacted by telephone 4-8 hours after 
immunization to obviate any adverse events (AE's). Peripheral blood mononuclear 
cells (PBMC) will be collected at baseline, first follow-up visit (week 7), 
colposcopy (week 9 and week 17) and at time of biopsy (week 25) to monitor 
HPV-specific immune responses. Colposcopy and digital imaging will be performed 
after immunization in week 9, in week 17 and in week 25 to monitor regression 
of the CIN lesions. If full regression of the lesion does not occur, LLETZ will 
be performed 25 weeks after the first immunization. LLETZ will also be 
performed if progression occurs (proven by biopsy) during the study. When 
complete regression of the CIN3 lesion is observed by colposcopy, a biopsy will 
be taken in week 25 to confirm regression. In this case, no LLETZ will be 
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult female patients (>=18 years) who have newly been diagnosed with HPV-16 positive CIN3 lesions and have signed written informed consent according to local guidelines. Patients of child-bearing potential should test negative using a pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study.
Exclusion criteria
Exclusion criteria: * PAP5 lesions. * Previously undergone treatment for CIN lesions. * Adenocarcinoma in situ within CIN3 lesion * History of 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 biochemistry, haematology and urinalysis performed at screening. * Any condition that in the opinion of the investigator could interfere with the conduct of the study. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoint is clinical efficacy of Vvax001. To assess vaccine induced clinical responses, histology of the pre-treatment diagnostic biopsy will be compared to histology of the post- treatment therapeutic biopsy/LLETZ. A positive response is defined as a reduction from CIN3 to CIN1, or a change from CIN3 to no dysplasia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are 1) the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses in peripheral blood at baseline, week 7, week 9, week 17 and week 25; 2) HPV16 clearance; and 3) potential side effects/adverse events related to Vvax001. | — |
Countries
Netherlands
Outcome results
None listed