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A Phase I Randomized Placebo Controlled Study of a Virosome Formulated Anti-Candida Vaccine (PEV7) Administered by the Vaginal (PEV7A) or Intramuscular (PEV7B) Route to Healthy Adult Volunteers

This study is currently Recruiting

March 2010 By Pevion Biotech Ltd

First Recieved on February 10, 2010

Last Updated on March 2, 2010

Sponsor: Pevion Biotech Ltd
Collaborators:
Information provided by: Pevion Biotech Ltd
Identifier: NCT01067131

Purpose

Pevion Biotech develops a state-of-the-art vaccine against recurrent vulvovaginal candidiasis (VVC) 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.

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

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

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 throughout the study. 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. - Negative culture for any Candida species at screening visit 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) at screening visit ; for group 3 and 4 at screening and at days 0?2, 28?2 and 56?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 immunoglobuline-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 84 for group 3 and 4) - Receipt of live attenuated vaccine within 30 days or other vaccine within 14 days of enrolment - Any therapy or medications via vaginal route 7 days prior to first vaccination and during the entire course of the study from first dose of study vaccine until the last safety visit (Group 1 and 2: day 140?2 ; Group 3 and 4: day 154 ?2) - Chronic administration (defined as more than 14 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 2. a clinically significant abnormality in the haematological or biochemicals assays 3. positive antibody assays for Hepatitis B and/or C and/or HIV - Any chronic drug therapy to be continued during the study period (except oral hormonal contraceptives) - Any confirmed or suspected acquired immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or history of congenital or hereditary immunodeficiency. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or component used during the manufacturing process of the vaccine like eggs and chick proteins. - Acute disease at the time of enrolment. {Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., temperature <38?C (<100.4?F)} - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, blood disorder or immune dysfunction as determined by physical examination or laboratory screening tests. - Acute or chronic diabetes - History of chronic alcohol consumption and/or intravenous drug abuse. - Pregnant or lactating female. - Female planning to become pregnant.

Investigators

  • Investigator: Giuseppe Pantaleo, Prof - Principal Investigator - Centre hosptialier universitaire vaudois, Vaccine and Immunotherapy Center

Locations

  • CHUV, Vaccine and Immunotherapy Center

    Lausanne, 1011 Switzerland

Conditions related to this trial:

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