Recurrent Vulvovaginal CandidiasisPhase 1NCT01067131
Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection
A Phase 1 study testing PEV7C1, PEV7C9 and PEV7B2 in people with Recurrent Vulvovaginal Candidiasis, run by Pevion Biotech Ltd at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Vulvovaginal Candidiasis
- What is being tested?
- PEV7C1, PEV7C9 and PEV7B2
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Mar 2010to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Covance Clinical Research Unit AG
Allschwil, Basel, 4123
CHUV, Vaccine and Immunotherapy Center
Lausanne, 1011
About this study
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
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
- Being tested
- PEV7C1, PEV7C9, PEV7B2, PEV7B1
- Keywords
- Candida albicans, Fungal vaginal infection, Vulvovaginal candidiasis, Candidose, Vaccine, Virosome
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEV7C1Biological
capsule intravaginal application contains antigen coupled to virosomes
PEV7C9Biological
capsule intravaginal application contains excipient only
PEV7B2Biological
reconstituted lyophilisate intramuscular application contains antigen at low dose coupled to virosomes
PEV7B1Biological
reconstituted lyophilisate intramuscular application contains antigen at high dose coupled to virosomes
| Study group | Role | What they receive |
|---|---|---|
| PEV7C1, intravaginal | Experimental | Vaccine containing virosomes intravaginally applied Receives: Biological: PEV7C1 |
| PEV7C9, placebo, intravaginal | Placebo comparator | Placebo vaccine (excipient only) intravaginally applied Receives: Biological: PEV7C9 |
| PEV7B2, intramuscular low dose | Experimental | Intramuscular vaccine low dose of antigen Receives: Biological: PEV7B2 |
| PEV7B1, intramuscular high dose | Experimental | Intramuscular vaccine, high dose of antigen Receives: Biological: PEV7B1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic and local AE rates / SAE rates
Measured: Immunization period + 3 months
Secondary outcomes (2)
Titers of vaccine antigen specific antibodies
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pevion Biotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuseppe Pantaleo, Prof, Principal investigator, Centre hospitalier universitaire vaudois, Vaccine and Immunotherapy CenterRolf Pokorny, MD, MSc, Principal investigator, Covance Clinical Research Unit AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067131
- Sponsor's protocol ID
- PCAN001
- Status last verified
- Dec 2012
- First submitted
- 10 Feb 2010
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01067131
- Acronym / sponsor ID
- PCAN001
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Keywords
- Candida albicans, Fungal vaginal infection, Vulvovaginal candidiasis, Candidose, Vaccine, Virosome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Pevion Biotech LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEV7C1, intravaginal | Experimental | Biological: PEV7C1Vaccine containing virosomes intravaginally applied |
| PEV7C9, placebo, intravaginal | Placebo comparator | Biological: PEV7C9Placebo vaccine (excipient only) intravaginally applied |
| PEV7B2, intramuscular low dose | Experimental | Biological: PEV7B2Intramuscular vaccine low dose of antigen |
| PEV7B1, intramuscular high dose | Experimental | Biological: PEV7B1Intramuscular vaccine, high dose of antigen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEV7C1capsule intravaginal application contains antigen coupled to virosomes | Biological | PEV7C1, intravaginal |
| PEV7C9capsule intravaginal application contains excipient only | Biological | PEV7C9, placebo, intravaginal |
| PEV7B2reconstituted lyophilisate intramuscular application contains antigen at low dose coupled to virosomes | Biological | PEV7B2, intramuscular low dose |
| PEV7B1reconstituted lyophilisate intramuscular application contains antigen at high dose coupled to virosomes | Biological | PEV7B1, intramuscular high dose |
Primary outcome
Systemic and local AE rates / SAE rates
Time frame: Immunization period + 3 months
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Pantaleo, Prof principal investigator
Centre hospitalier universitaire vaudois, Vaccine and Immunotherapy Center
Rolf Pokorny, MD, MSc principal investigator
Covance Clinical Research Unit AG
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEV7C1, PEV7C9 and PEV7B2 in people with Recurrent Vulvovaginal Candidiasis, run by Pevion Biotech Ltd at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic and local AE rates / SAE rates (time frame: Immunization period + 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2012.