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

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


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.


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




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


University of Alabama at Birmingham
United States




Sidney Kimmel Comprehensive Cancer Center

Results (where available)

View Results


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

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