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Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC when given together


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT00493545
Study type Interventional
Source Nventa Biopharmaceuticals Corporation
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 2007
Completion date June 2008

See also
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