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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: Completed Phase 1 study of HPV16 Positive and Cervical Intraepithelial Neoplasia (CIN 2/3), sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Presence of intervention-related serious adverse events as defined by CTCAE
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 |
What the finished NCT00988559 record still lists
NCT00988559 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT00988559's enrollment target sits among peer trials
132 432nd of 2000 higher than 1,562 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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