NCT01067131

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pevion Biotech Ltd · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Recurrent Vulvovaginal Candidiasis

Interventions

Type	Name	Description
BIOLOGICAL	PEV7C1	capsule intravaginal application contains antigen coupled to virosomes
BIOLOGICAL	PEV7C9	capsule intravaginal application contains excipient only
BIOLOGICAL	PEV7B2	reconstituted lyophilisate intramuscular application contains antigen at low dose coupled to virosomes
BIOLOGICAL	PEV7B1	reconstituted lyophilisate intramuscular application contains antigen at high dose coupled to virosomes

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-02-11
• Last updated: 2012-12-24

Locations

2 sites across 1 country: Switzerland