An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advaxis, Inc.
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Histamine Antagonists; Histamine H1 Antagonists

Criteria

Inclusion Criteria:

• Histologically confirmed CIN 2/3 that requires surgical intervention

Exclusion Criteria:

• Previous history of listeriosis

• Steroid use

• Antibiotic use

• Negative anergy panel

• HIV positive

• Pregnant or actively trying during the treatment period

• Intercurrent disease