drugset / Trial / 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

NCT02689726 ↗

Phase 1 Terminated 13 enrolled Genticel PPD Development, LP · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-08
Primary completion
2016-08
Completion
2016-08

Outcome

Outcome not reported

Stopped: “Lack of efficacy in European Phase 2 study”

Drugs

EvaluationDrugModalityDoseRoute
Subject GTL001 Vaccine — —
Background Imiquimod Other / unclassified 5 % Topical

Indications

No indication recorded.