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

A Phase 1, Open-Label Study to Evaluate the 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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Genticel · Industry
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1, Open-Label Study to Evaluate the 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.

Detailed description

This is an outpatient, open-label study. After a screening period of up to 4 weeks, all eligible subjects will receive 2 doses, 6 weeks apart, of GTL001 Powder reconstituted with water for injection. GTL001 will be adjuvanted with Aldara, 5% imiquimod cream, applied to the injection site 15 minutes and 24 hours after each vaccination. The follow-up period is 12 weeks from the first injection. The duration of the study is defined for each subject as the date that signed, written informed consent is provided through the last follow-up visit. Total duration of subject participation is approximately 16 weeks.

Conditions

• HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSIL

Interventions

Type	Name	Description
DRUG	GTL001+
DRUG	Aldara	5% imiquimod cream

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-02-24
• Last updated: 2016-12-02

Locations

4 sites across 1 country: United States