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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 Long Peptides Vaccination in Women with HPV16 Positive High Grade Vulvar/Vaginal Intraepithelial Neoplasia


- candidate number4341
- NTR NumberNTR1526
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2008
- Secondary IDsHPV01/01 2007-005230-37
- Public TitleRandomised Controlled Study on the Effects of Imiquimod, a TLR 7 Activating Agent, on the HPV16-Specific Immune Response Following HPV16 E6/E.7 Synthetic Long Peptides Vaccination in Women with HPV16 Positive High Grade Vulvar/Vaginal Intraepithelial Neoplasia
- Scientific TitleRandomised Controlled Study on the Effects of Imiquimod, a TLR 7 Activating Agent, on the HPV16-Specific Immune Response Following HPV16 E6/E7 Synthetic Long Peptides Vaccination in Women with HPV16 Positive High Grade Vulvar/Vaginal Intraepithelial Neoplasia.
- ACRONYMN/A
- hypothesisThis study aims to compare the immunological response to vaccination with HPV16 E6 and E7 synthetic long peptides with concomitant application of imiquimod at the vaccination site with vaccination without the concomitant application of imiquimod.
- Healt Condition(s) or Problem(s) studiedVulvar intraepithelial neoplasia (VIN), Human Papilloma Virus (HPV), Vaccination, Imiquimod, Vaginal intraepithelial neoplasia
- Inclusion criteria1. 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.
3. Histological evidence of high grade VIN and/or VaIN, HPV16 positive.
4. Baseline laboratory findings; white blood cells (WBC) > 3,000 x 109/l, lymphocytes > 1,000 x 109/l, platelets > 100 x 109/l.
5. HIV- and HBV-negative.
6. 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.
- Exclusion criteria1. 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.
3. VaIN lesions that are not distinguishable from a co-existing cervical intraepithelial neoplasia (CIN) lesion.
4. History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy including transplant recipients.
5. History of a second malignancy except curatively treated low-stage tumours with a histology that can be differentiated from the vulvar, vaginal and cervical cancer type.
6. Radiotherapy, chemotherapy administered within 4 weeks prior to the enrolment visit.
7. Participation in a study with another investigational drug within 30 days prior to the enrolment in this study.
8. Any condition that in the opinion of the investigator could interfere with the conduct of the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-okt-2008
- planned closingdate31-mrt-2011
- Target number of participants36
- InterventionsAll patients will be vaccinated four times with three week intervals with HPV16 E6 and E7 synthetic long peptides (ISA-HPV-01) at a dose of 300 ėg /peptide in 2 separated subcutaneous injections.
Patients will be randomized to either: arm 1 is to receive local application of imiquimod on the vaccination sites one hour and 48 hours after each vaccination, arm 2 will not apply anything to the vaccination site.
- Primary outcomeThe immunological response to vaccination with HPV16 E6 and E7 synthetic long peptides with and without concomitant application of imiquimod at the vaccination site.
- Secondary outcomeSafety and clinical response to vaccination with HPV16 E6 and E7 synthetic long peptides with and without concomitant application of imiquimod at the vaccination site.
- Timepoints- 3 weeks after second and last vaccination
- 3 and 12 months after last vaccination.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. G. Kenter
- CONTACT for SCIENTIFIC QUERIESProf. Dr. H.W. Nijman
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Isa pharmaceuticals B.V.
- PublicationsN/A
- Brief summaryHuman Papilloma Virus (HPV)16 infection may cause vulvar intraepithelial neoplasia (VIN), and/or vaginal intraepithelial neoplasia, (VaIN). Vaccination with synthetic long peptides encoding for the oncogenes E6 and E7 from HPV16 may stimulate the immune system to elimintate the virus and associated lesions. This study will compare the immunological response after vaccination with and without the local application of imiquimod to the vaccination site. Also clinical response is measured up to 12 months after vaccination.
- Main changes (audit trail)
- RECORD6-nov-2008 - 27-nov-2008


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