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

PHASE2TerminatedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

December 31, 2013

Study Completion Date

April 30, 2016

Conditions
Cervical Intraepithelial Neoplasia
Interventions
BIOLOGICAL

ADXS11-001 (Lm-LLO-E7)

ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.

DRUG

Placebo Control

3 intravenous infusions of normal saline at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.

Trial Locations (15)

10038

New York Downtown Hospital, New York

10461

Montefiore Medical Center, The Bronx

19140

Temple University, Philadelphia

33461

Altus Research, Lake Worth

33472

Visions Clinical Research, Boynton Beach

46202

Indiana University Dept. of OB/GYN Oncology, Indianapolis

60612

Center for Women, Chicago

78212

InVisions Consultants, LLC- c/o Institute for Women's Health, San Antonio

78217

InVisions Consultants, LLC, San Antonio

84107

Wasatch Clinical Research, Salt Lake City

85016

Arizona OB/GYN Affiliates, PC, Phoenix

85032

Precision Trials, Phoenix

85224

New Horizons Women's Care, LLC, Chandler

85712

Visions Clinical Research - Tucson, Tucson

91942

Grossmont Center for Clinical Research, La Mesa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Advaxis, Inc.

INDUSTRY

NCT01116245 - An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+ | Biotech Hunter | Biotech Hunter