CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccinebiological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Histologically confirmed cervical intraepithelial neoplasia (CIN2/3)
  • ✓Human papillomavirus-16-positive disease
  • ✓Age >18 years
  • ✓Immunocompetent
Key exclusion· 1
  • ✕Pregnancy

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

Search/NCT00121173
NCT00121173Phase 2Completed
CompareCT.gov

A Phase I/II Clinical Trial of pNGVL4a-Sig/E7 (Detox)/HSP70 for the Treatment of Patients With HPV 16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jul 21, 2005·Updated Jul 20, 2018

In Brief

A Phase 2 clinical trial evaluating pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine for Cervical Cancer and Precancerous Condition. Completed, enrolled 16 participants across 1 site.

Detailed Summary

RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent cervical cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Precancerous Condition
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2005
Enrollment StartNov 1, 2003
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 20.9 years ago

Interventions

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccinebiological

recombinant DNA vaccine