NCT00493545

Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia

A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Nventa Biopharmaceuticals Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
BIOLOGICAL	HspE7 and Poly-ICLC	3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-06-28
• Last updated: 2008-05-07

Locations

8 sites across 1 country: United States