Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-02-20 @ 2:49 PM
Study NCT ID:
NCT00988559
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
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
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P50CA098252 | NIH | None | https://reporter.nih.gov/quic… | View |
| 1R21CA128232 | NIH | None | https://reporter.nih.gov/quic… | View |
| NA_00020850 | OTHER | JHM IRB | View |