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SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells

NCT00091130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2013-06-03

No results posted yet for this study

Summary

This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune response to kill human papillomavirus and abnormal cervical cells and may be effective in preventing cervical cancer

Conditions

  • Atypical Squamous Cells of Undetermined Significance
  • Cervical Cancer
  • High-grade Squamous Intraepithelial Lesion
  • Low-grade Squamous Intraepithelial Lesion

Interventions

BIOLOGICAL

HspE7

Given SC

OTHER

placebo

Given SC

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Frank Meyskens · University of California Medical Center At Irvine-Orange Campus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00091130 on ClinicalTrials.gov