Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT00988559
Brief Summary:
This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.
Detailed Description:
Primary Objectives
* To evaluate the feasibility and toxicity of vaccination in women with CIN2/3 caused by HPV16
* To evaluate the effect of vaccination on histology
* To compare immunogenicity of three different routes of administration: intradermal (ID), intramuscular (IM), intralesional (IL).
Secondary Objectives:
* To evaluate changes in HPV viral load
* To evaluate the cellular immune response to vaccination
* To evaluate the humoral immune response to vaccination
* To evaluate local tissue immune response
* To correlate measures of immune response with clinical response
* To correlate measures of immune response with those observed in the preclinical model
Study:
NCT00988559
Study Brief:
Protocol Section:
NCT00988559