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Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT01067131•Pevion Biotech Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Females aged between 18 and 45 years.
•Written informed consent obtained from the volunteer.
•Free of obvious health problems as established by medical history and/or clinical examination and/or gynecological examination before entering the study.
•Body Mass Index between 18.0 and 30.0.
•A negative pregnancy test and an adequate contraception until at least 4 weeks after the last vaccination of the primary vaccination course. Adequate contraception means use of a physician-prescribed oral hormonal agent AND use of condoms (without spermicidal agents) at the same time. Progesterone-only contraceptives are not suitable due to the lack of a regular menstrual cycle.
•Availability for the duration of the study and willingness to attend all scheduled visits.
•No vaginal practices other than receptive intercourse with male or use of sanitary tampons during menses.

Exclusion Criteria

•Known or suspect history of cervico-vaginal malignancy or abnormality discovered at time of screening. Ovarectomised and hysterectomised women are excluded from the study.
•Presence of Chlamydia trachomatis, Neisseria gonorrhoeae infection as detected by PCR at screening visit.
•Presence of bacterial vaginosis (assessed by the Amsel criteria and bacterial culture) for group 1 and 2 at screening visit; at days 0±2, 28±2 and 56±2, for group 3 and 4 at screening and by Amsel criteria only at days 0±2 and 28±2.
•Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up.
•Planned use of any registered vaccine other than study vaccine and planned use of immunoglobulin-based therapy during the immunization phase until 14 days after the last immunization (Day 0 to day 70 for group 1 and 2; Day 0 to Day 56 for group 3 and 4) and for groups 1 and 2 from application of booster vaccine dose until 14 days after administration.
•Receipt of live attenuated vaccine within 30 days prior to the first vaccination until 30 days after the last vaccination of the immunization period. Equally the above applies to the period 30 days prior until 30 days after the booster vaccination.
•Any therapy or medications via vaginal route 7 days prior to first vaccination and in the period from first dose of study vaccine until the last safety visit (Groups 1 and 2: Day 140±2; Groups 3 and 4: Day 70±2). Equally the above applies to the period 7 days prior to booster vaccination until end of study (Groups 1 and 2).
•Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, \> 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Samples obtained at screening visit show:
•1. a clinically significant amount of protein and/or haemoglobin in the urine sample
+11 more criteria

Locations (2)

Covance Clinical Research Unit AG

Allschwil, Basel, Switzerland

CHUV, Vaccine and Immunotherapy Center

Lausanne, Switzerland

Key Dates

Start Date

March 1, 2010

Primary Completion Date

December 1, 2012

Completion Date

December 1, 2012

Last Updated

December 24, 2012

Enrollment

ACTUAL participants

Conditions

Recurrent Vulvovaginal Candidiasis

Interventions

PEV7C1

BIOLOGICAL

PEV7C9

BIOLOGICAL

PEV7B2

BIOLOGICAL

PEV7B1

BIOLOGICAL

Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study

NCT06190509

Recurrent Vulvovaginal Candidiasis

View study

COMPLETEDPHASE3

A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

NCT03561701

Recurrent Vulvovaginal Candidiasis

View study

COMPLETEDPHASE4

Study of Lactobacillus in Adjuvant Treatment of RVVC

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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