Wetenschappelijk onderzoek naar de veiligheid van HPV-DNA vaccinatie en reactie van hetafweersysteem op deze vaccinatie bij patiënten met een HPV16-positieve afwijking aan deschaamlippen.

Recruiting

• Conditions: DNA tattoo vaccination; uVIN; usual vulvar intraepithelial neoplasia; HPV16; sig-HELP-E6SH/E7SH-kdel; vulvaire intraepitheliale neoplasie; HPV vaccinatie

• Registration Number: NL-OMON29038
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Age above 18 years

• Willing and able to undergo the planned study procedures

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objectives:<br /><br>• To study the systemic HPV-specific immune response of two naked DNA vaccines<br>encoding sig-HELP-kdel and shuffled HPV16 E6 or E7 gene products (sig-HELPE6SH/<br>E7SH-kdel).

Secondary Outcome Measures

Name	Time	Method
Secondary objective:<br /><br>• To study the safety of sig-HELP-E6SH/E7SH-kdel.<br /><br>• To study the clinical response to vaccination of sig-HELP-E6SH/E7SH-kdel.<br /><br><br /><br>Exploratory objectives:<br /><br>• To study the migratory capacity of HPV16-specific T cells by analysis of their<br>presence in vaccine sites.<br /><br>• The effect of vaccination on the immune infiltrate in VIN lesion microenvironment will<br>be determined by multicolour fluorescent immunohistochemistry.