Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL

PHASE1TerminatedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSIL
Interventions
DRUG

GTL001+

DRUG

Aldara

5% imiquimod cream

Trial Locations (4)

19107

Planned Parenthood Southeastern Pennsylvania, Philadelphia

27612

Wake Research Associates, LLC, Raleigh

40208

University of Louisville, Louisville

43213

Clinical Research Advantage, Inc./ Columbus Obstetricians and Gynecology, Inc., Columbus

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Genticel

INDUSTRY

NCT02689726 - Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL | Biotech Hunter | Biotech Hunter