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

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
• •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 enrollment. {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.
• •Pregnancy or lactation.
• •Subject planning to become pregnant.