Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00988559 · ClinicalTrials.gov registry record · Phase 1
Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
A Phase 1 study of HPV16 Positive and Cervical Intraepithelial Neoplasia (CIN 2/3), sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
- 3
- Study locations
NCT00988559 is a Phase 1 study of HPV16 Positive and Cervical Intraepithelial Neoplasia (CIN 2/3) that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 132 participants. The trial reports 3 study locations across 2 states.
The verdict
NCT00988559, a Phase 1 study of HPV16 Positive and Cervical Intraepithelial Neoplasia (CIN 2/3), has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL DNA vaccination
- DEVICE Gene gun vaccine
- BIOLOGICAL intramuscular vaccination
- BIOLOGICAL intra-lesional vaccine administration
- PROCEDURE therapeutic resection of the lesion
Study Locations (3)
Maryland
- Johns Hopkins Outpatient Center - Baltimore
- Johns Hopkins Bayview Medical Center - Baltimore
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2009-09 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00988559
The ClinicalTrials.gov registry entry for NCT00988559 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HPV16 Positive appearing as the primary indexed condition, and to 5 interventions - of which DNA vaccination is the first listed.
NCT00988559 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Alabama.
Frequently Asked Questions
What is clinical trial NCT00988559 about?
NCT00988559 is a clinical study titled "Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)". 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 d...
What is the current status of trial NCT00988559?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2009-09. Estimated completion is 2016-07.
What conditions does trial NCT00988559 study?
This clinical trial studies the following conditions: HPV16 Positive, Cervical Intraepithelial Neoplasia (CIN 2/3).
What interventions are being tested in trial NCT00988559?
The interventions under investigation include: DNA vaccination (BIOLOGICAL), Gene gun vaccine (DEVICE), intramuscular vaccination (BIOLOGICAL), intra-lesional vaccine administration (BIOLOGICAL), therapeutic resection of the lesion (PROCEDURE).
Who is sponsoring clinical trial NCT00988559?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00988559 being conducted?
This trial has 3 study locations across Alabama, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.