NCT00091130

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

An Exploratory Study to Evaluate the Effect of HPV 16 Vaccine on the Reduction of Viral Load in HPV 16 Positive Women With Persistent Viral Infection, But Low Grade Disease (ASCUS/LSIL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Detailed description

PRIMARY OBJECTIVES: I. Compare the effectiveness of SGN-00101 vaccine vs placebo in reducing the human papillomavirus (HPV)-16 viral load in patients with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) of the cervix with persistent HPV-16 infection who are at increased risk for developing a high-grade squamous intraepithelial lesion or invasive cervical cancer. II. Compare the natural history of HPV-16 viral load in patients treated with these regimens. III. Compare the effect of HPV-16 variants on viral load response in patients treated with these regimens. IV. Compare the relative effectiveness of these regimens on the regression of cervical cellular atypias (based on Pap test results), in terms of the regression of cytologic findings of LSIL and ASCUS to normal findings and resolution or regression of colposcopically defined cervicovaginal lesions, in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive SGN-00101 vaccine subcutaneously (SC) on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness. ARM II: Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness. Patients are followed at 12, 24, and 52 weeks after the last vaccination.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	HspE7	Given SC
OTHER	placebo	Given SC
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-06-01
• First posted: 2004-09-08
• Last updated: 2013-06-03

Locations

1 site across 1 country: United States