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

NCT01067131 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-12-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pevion Biotech Ltd

    lead INDUSTRY

Principal Investigators

  • Giuseppe Pantaleo, Prof · Centre hospitalier universitaire vaudois, Vaccine and Immunotherapy Center

  • Rolf Pokorny, MD, MSc · Covance Clinical Research Unit AG

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01067131 on ClinicalTrials.gov