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Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)

2014-08-27 03:18:53 | BioPortfolio

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.

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 Design

Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

HPV16+

Intervention

DNA vaccination, Gene gun vaccine, intramuscular vaccination, intra-lesional vaccine administration, therapeutic resection of the lesion

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35294

Status

Recruiting

Source

Sidney Kimmel Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:53-0400

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