ong term follow up of the clinical and immunological responses following HPV 16 E6/E7 synthetic long peptides vaccination in women with HPV 16 positive vulvar intraepithelial neoplasia grade 3

Recruiting

• Conditions: VIN; vulvair intraepithelial neoplasia; 10038594

• Registration Number: NL-OMON36101
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

Patients are eligible and will be included if they participated in the initial phase II study and provide informed consent for the current study.

Exclusion Criteria

There are no exclusion criteria for this follow up study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The long term clinical and immunological responses will be assessed by use of<br /><br>history taking, histology, HPV typing and measurement of HPV-specific T-cell<br /><br>responses in peripheral blood T-lymphocytes. The immunological results will be<br /><br>compared with the results during the initial trial and the clinical results<br /><br>will be compared with the baseline and after 24 months of initial follow up<br /><br>characteristics. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluation of adverse drug reactions in terms of local adverse events at the<br /><br>inoculation sites and possible related systemic events after HPV-SLP<br /><br>vaccination.</p><br>