Long 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

Long 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 - Long term follow up of HPV 16 E6/E7 SLP vaccine in VIN 3 lesions

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36101

Enrollment

Registered

2011-07-12

Start date

2011-09-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VIN vulvair intraepithelial neoplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: There are no exclusion criteria for this follow up study.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Evaluation of adverse drug reactions in terms of local adverse events at the inoculation sites and possible related systemic events after HPV-SLP vaccination.	—

Countries

Netherlands

Outcome results