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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pevion Biotech Ltd
ClinicalTrials.gov Identifier:
NCT01067131
First received: February 10, 2010
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Recurrent Vulvovaginal Candidiasis
Biological: PEV7C1
Biological: PEV7C9
Biological: PEV7B2
Biological: PEV7B1
Phase 1

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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pevion Biotech Ltd:

Primary Outcome Measures:
  • Systemic and local AE rates / SAE rates [ Time Frame: Immunization period + 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Titers of vaccine antigen specific antibodies [ Time Frame: Immunisation phase, last immunisation +2 weeks, +1 month, +3 months, +6 months, +12 months, +14 months (Groups 1&2 only), +15 months (Groups 1&2 only) ] [ Designated as safety issue: No ]
  • Neutralisation capacity of vaccine antigen specific antibodies [ Time Frame: Immunisation phase, last immunisation +2 weeks, +1 month, +3 months, +6 months, +12 months, +14 months (Groups 1&2 only), +15 months (Groups 1&2 only) ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEV7C1, intravaginal
Vaccine containing virosomes intravaginally applied
Biological: PEV7C1
capsule intravaginal application contains antigen coupled to virosomes
Placebo Comparator: PEV7C9, placebo, intravaginal
Placebo vaccine (excipient only) intravaginally applied
Biological: PEV7C9
capsule intravaginal application contains excipient only
Experimental: PEV7B2, intramuscular low dose
Intramuscular vaccine low dose of antigen
Biological: PEV7B2
reconstituted lyophilisate intramuscular application contains antigen at low dose coupled to virosomes
Experimental: PEV7B1, intramuscular high dose
Intramuscular vaccine, high dose of antigen
Biological: PEV7B1
reconstituted lyophilisate intramuscular application contains antigen at high dose coupled to virosomes

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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.
  • Negative culture for any Candida species before visit 2. Subjects with a positive culture will be treated and the Candida culture will be repeated. They will be eligible if a negative culture result is available prior to visit 2 (first vaccination).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067131

Locations
Switzerland
Covance Clinical Research Unit AG
Allschwil, Basel, Switzerland, 4123
CHUV, Vaccine and Immunotherapy Center
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Pevion Biotech Ltd
Investigators
Principal Investigator: Giuseppe Pantaleo, Prof Centre hospitalier universitaire vaudois, Vaccine and Immunotherapy Center
Principal Investigator: Rolf Pokorny, MD, MSc Covance Clinical Research Unit AG
  More Information

No publications provided

Responsible Party: Pevion Biotech Ltd
ClinicalTrials.gov Identifier: NCT01067131     History of Changes
Other Study ID Numbers: PCAN001
Study First Received: February 10, 2010
Last Updated: December 21, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Pevion Biotech Ltd:
Candida albicans
Fungal vaginal infection
Vulvovaginal candidiasis
Candidose
Vaccine
Virosome

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases

ClinicalTrials.gov processed this record on October 01, 2014