CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 132 enrolled
Drug / intervention
DNA vaccination +5 morebiological
Likely dose
intramuscular vaccination 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00988559
NCT00988559Phase 1Completed
CompareCT.gov

A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Oct 2, 2009·Updated Jul 9, 2018

In Brief

A Phase 1 clinical trial evaluating DNA vaccination, Gene gun vaccine, and 4 other interventions for HPV16 Positive and Cervical Intraepithelial Neoplasia (CIN 2/3). Completed, enrolled 132 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHPV16 Positive, Cervical Intraepithelial Neoplasia (CIN 2/3)
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2009
Enrollment StartSep 1, 2009
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 16.8 years ago

Interventions

DNA vaccinationbiological

vaccination with pNGVL4a-CRT/E7(detox)

Gene gun vaccinedevice

8 micrograms (group 1) or 16 micrograms (group 2)

intramuscular vaccinationbiological

1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly

intra-lesional vaccine administrationbiological

1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally

therapeutic resection of the lesionprocedure

at week 15, all residual lesions will be resected

imiquimoddrug

imiquimod applied to the cervix by the physician