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

HPV16 Positive Clinical Trial

Official title:
A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00988559
Study type	Interventional
Source	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status	Completed
Phase	Phase 1
Start date	September 2009
Completion date	July 2016

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