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)
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
III. Compare the effect of HPV-16 variants on viral load response in patients treated with
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
HPV-16 viral load
Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model. The univariate logistic regression model for infection resolution is equivalent to a chi-square test.
University of California Medical Center At Irvine-Orange Campus
United States: Institutional Review Board
|University of California Medical Center At Irvine-Orange Campus||Orange, California 92868|