Clinical Trial: Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
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 Summary:
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
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Current Primary Outcome: To evaluate feasibility and toxicity in women with CIN2/3 caused by HPV16 [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To compare immunogenicity of three different routes of administration: intradermal (ID), intramuscular (IM), and intralesional (IL) [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Sidney Kimmel Comprehensive Cancer Center
Dates:
Date Received: October 1, 2009
Date Started: September 2009
Date Completion: March 2017
Last Updated: March 8, 2016
Last Verified: March 2016