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

Recurrent Vulvovaginal Candidiasis Clinical Trial

Official title:
A Phase I Randomized Placebo Controlled Study of a Virosome Formulated Anti-Candida Vaccine (PEV7) Administered by the Vaginal (PEV7C) or Intramuscular (PEV7B) Route to Healthy Adult Volunteers

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01067131
Study type Interventional
Source Pevion Biotech Ltd
Contact
Status Completed
Phase Phase 1
Start date March 2010
Completion date December 2012
View Details
See also
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