A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate feasibility and toxicity in women with CIN2/3 caused by HPV16
2 years
Yes
Cornelia L Trimble, MD
Principal Investigator
Johns Hopkins University
United States: Food and Drug Administration
J0866, NA_00020850
NCT00988559
September 2009
December 2014
Name | Location |
---|---|
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Johns Hopkins Outpatient Center | Baltimore, Maryland 21287 |
Johns Hopkins Bayview Medical Center | Baltimore, Maryland 21224 |