Safety, immunogenicity and clinical response of sig-HELP-E6SH/E7SH-kdel, injected in the epidermis by DNA tattoo, in HPV16-positive vulvar intraepithelial neoplasia: a phase I/II study

Safety, immunogenicity and clinical response of sig-HELP-E6SH/E7SH-kdel, injected in the epidermis by DNA tattoo, in HPV16-positive vulvar intraepithelial neoplasia: a phase I/II study - HPV16 E6-E7

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47893

Enrollment

Registered

2016-01-14

Start date

2016-12-12

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

uVIN vulvar dysplasia

Interventions

Sig-HELP-E6SH/E7SH-kdel will be injected intradermally on days 0, 14, 28 and 42 using a permanent make-up device (Derm.MT GmbH, Berlin, Germany).

Eligibility

Age

18 Years to 99 Years

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
* 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-HELP-E6SH/E7SH-kdel).	—

Secondary

Measure	Time frame
* 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.	—

Measure

Time frame

* 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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)