The purpose of this Phase II study is to provide data regarding the safety and immunogenicity for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative for high-risk HPV DNA. The study is designed to evaluate safety and immunogenicity data for MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will provide long-term immune response data. This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.
This is a Phase II double-blind, randomized, dose-comparison, multicenter study in the United States of three different dose levels of MEDI-517 (HPV-16/18 VLP AS04 vaccine) and one dose of MEDI-517 formulated with aluminum hydroxide, with doses administered at 0, 30 and 180 days. Healthy female volunteers 18 through 30 years of age will be entered into 4 treatment arms. The objectives of study are to evaluate reactogenicity, safety and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
210
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Solicited adverse event rates (including injection site and systemic reactions)
Time frame: For 7 days after each injection
Unsolicited adverse event rates
Time frame: For 30 days after each injection
Serious adverse event rates
Time frame: From first injection through 30 days after last injection
Laboratory assessments (Biochemistry and Hematology parameters)
Time frame: Study Days 0, 30 and 210
Vital signs (temperature, blood pressure, pulse rate, respiratory rate)
Time frame: At the time of injection and 30 minutes after the injection
Serum ELISA titers against HPV-16 and HPV-18
Time frame: 30 days after the third injection
Serum ELISA titers against HPV-16 and HPV-18
Time frame: Study Days 0, 7, 30, 60, 180, 210, and 360, and at 24, 36, and 48 months
Neutralization titers against HPV-16 and HPV-18
Time frame: Study Days 0, 60, 210 and 360
Cell-mediated immunity by IL-5, IFN-γ and lymphoproliferative assays
Time frame: Study Days 0, 60, 210, and 360
HPV-16 and HPV-18 ELISA and inhibitory ELISA
Time frame: Study Days 0, 60, 210, and 360, and at 18, 24, 36, and 48 months
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Cervical and vaginal ELISA titers against HPV-16 and HPV-18
Time frame: At Study Days 210 and 360