drugset / Trial / NCT01067131

Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection

NCT01067131 ↗

Phase 1 Completed 48 enrolled Pevion Biotech Ltd
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Pevion Biotech develops a state-of-the-art vaccine against recurrent vulvovaginal candidiasis (RVVC) caused by the pathogenic form of Candida albicans especially in pre-menopausal women of childbearing age with a history of recurrent vulvovaginal candidiasis. This study is designed to evaluate the safety and tolerability of the vaccine, administered by two different routes (intramuscular and intravaginal) as primary endpoint. Immunogenicity will be evaluated as secondary endpoint.

Timeline

Start
2010-03
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject PEV7B1 Unknown — Intramuscular
Subject PEV7B2 Unknown — Intramuscular
Subject PEV7C1 Unknown — Other