DNA tattoo vaccination
Conditions
Interventions
This is a phase I/II trial to evaluate the toxicity, immunogenicity and clinical response of two novel HPV DNA vaccines (sig-HELP-E6SH-kdel and sig-HELPE7SH-kdel), applied by DNA tattoo vaccination, i
Sponsors
NKI-AVL
Eligibility
Inclusion criteria
Inclusion criteria: • Age above 18 years • Willing and able to undergo the planned study procedures • Written informed consent • Histologically proven visible uVIN lesion (histology ≤3 months prior to enrolment and at least 6 weeks after last treatment) • HPV16-positive VIN lesion (to be determined on archival tumour tissue (≤10 years old); if not available a new biopsy will be required) • No indication of an active infectious disease: HIV, HCV and HBV negative • No history of autoimmune disease or systematic undercurrent disease which might affect immunocompetence • Adequate bone marrow (WBC > 3.0/nL, platelets > 100/nL), renal function (creatinine clearance > 40 mL/min), and liver function (bilirubin < 1.5 x ULN, normal blood coagulation)
Exclusion criteria
Exclusion criteria: • Prior treatment with anti-HPV agents • Participation in a study with another investigational drug within 30 days prior to enrolment in this study • Severe cardiac, respiratory, or metabolic disease • Use of systemic steroids or other immunosuppressive drugs • Use of oral anticoagulant drugs (except ascal) • Severe infections requiring antibiotics • Any treatment for the uVIN lesion within 6 weeks prior to the enrolment (including imiquimod) • Lactation or pregnancy (if applicable) • Not willing to take adequate contraceptive measures (if applicable)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives: • To study the systemic HPV-specific immune response of two naked DNA vaccines encoding sig-HELP-kdel and shuffled HPV16 E6 or E7 gene products (sig-HELPE6SH/ E7SH-kdel). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: • To study the safety of sig-HELP-E6SH/E7SH-kdel. • To study the clinical response to vaccination of sig-HELP-E6SH/E7SH-kdel. Exploratory objectives: • To study the migratory capacity of HPV16-specific T cells by analysis of their presence in vaccine sites. • The effect of vaccination on the immune infiltrate in VIN lesion microenvironment will be determined by multicolour fluorescent immunohistochemistry. | — |
Contacts
Public ContactJossie Rotman
VUmc-Cancer Center Amsterdam, CCA 2 - 48
Outcome results
None listed