The goals of this study are to describe the safety, reactogenicity and immunogenicity of MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected. 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, comparative trial of three formulations of MEDI-517 given at 0, 30, and 180 days by intramuscular injection. The volunteers in this study will be healthy females 18 through 30 years of age. The study collects safety, reactogenicity and immunogenicity data of MEDI-517 with and without adjuvant. Extended follow-up will provide long-term immune response data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Solicited adverse event rates (including injection site and systemic reactions)
Time frame: For 7 days after each injection
Solicited adverse event rates
Time frame: For 30 days after each injection
Serious adverse event rates
Time frame: From first injection through 6 months after last injection
Laboratory assessments (Chemistry 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 each injection and 30 minutes after each 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 18, 24, 36, and 48 months
Neutralization titers against HPV-16 and HPV-18
Time frame: Study Days 0, 60, 210 and 360
Inhibitory ELISAs
Time frame: Study Days 0, 60, 210, and 360, and at 18, 24, 36, and 48 months
Lymphoproliferative, IL-5, and IFN-γ assays
Time frame: Study Days 0, 60, 210, and 360, and at 18, and 24 months
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