Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects
The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC when given together
Approximately 600 million people worldwide are infected with the Human Papilloma Virus. In
the majority of cases people can clear the virus on their own however in cases where the
infection is not recognized or is left untreated, the result can be cervical cancer.
This study will examine the safety and tolerability of Hsp-E7 and Poly-ICLC administered
together as a vaccine for Cervical Intraepithelial neoplasia (CIN). There will be 4 cohorts
of subjects in the study each given a higher dose than the one prior providing that prior
dose has been well tolerated and deemed to be safe.
Subjects will be immunized every 28 days for a period of 8 weeks (3 administrations).
Posttreatment evaluation will occur 4 weeks after the last of 3 injections. Subjects with
CIN 2 or 3 disease at the time of enrollment will be eligible to undergo clinically
appropriate therapeutic treatment of the cervix at the twelfth of the study.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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