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

NCT01067131 | Completed Phase 1 DMC

• 1 other identifier: PCAN001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Candida albicans; Fungal vaginal infection; Vulvovaginal candidiasis; Candidose; Vaccine; Virosome

Outcome Measures

Primary Outcomes (1)

• Systemic and local AE rates / SAE rates

  Immunization period + 3 months

Secondary Outcomes (2)

• Titers of vaccine antigen specific antibodies

  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)

• Neutralisation capacity of vaccine antigen specific antibodies

  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)

Study Arms (4)

PEV7C1, intravaginal

EXPERIMENTAL

Vaccine containing virosomes intravaginally applied

Biological: PEV7C1

PEV7C9, placebo, intravaginal

PLACEBO COMPARATOR

Placebo vaccine (excipient only) intravaginally applied

Biological: PEV7C9

PEV7B2, intramuscular low dose

EXPERIMENTAL

Intramuscular vaccine low dose of antigen

Biological: PEV7B2

PEV7B1, intramuscular high dose

EXPERIMENTAL

Intramuscular vaccine, high dose of antigen

Biological: PEV7B1

Interventions

PEV7C1 BIOLOGICAL

capsule intravaginal application contains antigen coupled to virosomes

PEV7C1, intravaginal

PEV7C9 BIOLOGICAL

capsule intravaginal application contains excipient only

PEV7C9, placebo, intravaginal

PEV7B2 BIOLOGICAL

reconstituted lyophilisate intramuscular application contains antigen at low dose coupled to virosomes

PEV7B2, intramuscular low dose

PEV7B1 BIOLOGICAL

reconstituted lyophilisate intramuscular application contains antigen at high dose coupled to virosomes

PEV7B1, intramuscular high dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• a clinically significant amount of protein and/or haemoglobin in the urine sample
• a clinically significant abnormality in the haematological or biochemicals assays
• 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.

Sponsors & Collaborators

• Pevion Biotech Ltd: lead

Study Sites (2)

Covance Clinical Research Unit AG

Allschwil, Basel, 4123, Switzerland

Location

CHUV, Vaccine and Immunotherapy Center

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Giuseppe Pantaleo, Prof

  Centre hospitalier universitaire vaudois, Vaccine and Immunotherapy Center

  PRINCIPAL INVESTIGATOR

• Rolf Pokorny, MD, MSc

  Covance Clinical Research Unit AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

CH (2)