Randomised Controlled Study on the Effects of Imiquimod, a TLR 7 Activating Agent,on the HPV16-Specific Immune Response Following HPV16 E6/E.7 Synthetic LongPeptides Vaccination in Women with HPV16 Positive High Grade Vulvar/VaginalIntraepithelial Neoplasia
Recruiting
- Conditions
- High grade vulvar and/or vaginal intraepithelial neoplasias which are HPV16 positive.
- Registration Number
- NL-OMON21989
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
1. Patients of 18 years and older.
2. Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines.
Exclusion Criteria
1. Known hypersensitivity to the vaccine or imiquimod or to any of the respective excipients.
2. Indication of a current active infectious disease of the vulva or other infections that need medical attention, other than HPV16.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The immunological response to vaccination with HPV16 E6 and E7 synthetic long peptides with and without concomitant application of imiquimod at the vaccination site.
- Secondary Outcome Measures
Name Time Method Safety and clinical response to vaccination with HPV16 E6 and E7 synthetic long peptides with and without concomitant application of imiquimod at the vaccination site.