drugset / Trial / NCT01067131
Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEV7B1 | Unknown | — | Intramuscular |
| Subject | PEV7B2 | Unknown | — | Intramuscular |
| Subject | PEV7C1 | Unknown | — | Other |