Genital Infection ViralPhase 2RHEIA-VACNCT01957878
Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL
A Phase 2 study testing ProCervix in people with Genital Infection Viral and HUMAN PAPILLOMA VIRUS, run by Genticel at 40 sites in 7 countries.
Trial summary
Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Genital Infection Viral, HUMAN PAPILLOMA VIRUS
- What is being tested?
- ProCervix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 40 sitesin 7 countries
- Study dates
- Dec 2013to Oct 2016
- Phase
- Phase 2
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A subject will be eligible for inclusion in this study if the following criteria apply:
- Subject is female between the ages of 25 and 50 years (inclusive).
- Subject is pre-menopausal .
- Subject must have cervical HPV 16 and/or 18 infection confirmed by RT-PCR
- Subject has a cervical cytological evaluation with a normal, ASCUS or LSIL result at baseline.
- Subject has employed highly effective contraception the month prior to the first vaccination and will agree to employ highly effective contraception for at least 12 months after the first vaccination. .
Show all 9Show fewer
- Subject is in general good health based on medical history and physical examination.
- Subject is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
- Subject voluntarily gives written informed consent to participate in the study.
Who cannot join
- Subject has a current acute or chronic disease, other than infection with HPV, which would be expected to interfere with the planned evaluations of response
- Subject has vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators (SERMs).
- Subject has prior exposure to HPV prophylactic vaccine or subject has participated in the past in another vaccination clinical trial related to infection with HPV
- Current high grade lesions or history of untreated high grade cervical lesion (either CIN2 or CIN3).
- Subject has current or a history of cancer of the cervix.
- Subject has clinically significant (CS) gynaecological abnormalities that could interfere with study evaluation, in the judgment of the Investigator (e.g. prolapse, myoma, fibroid, hysterectomy).
Show all 20Show fewer
- Subject has a laboratory abnormality Grade ≥ 2, as defined using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials,
- Subject has received any live viral vaccine within 3 months or any other non live vaccine within 2 weeks of first study product administration.
- Subject has primary or secondary systemic immunosuppression
- Subject has a history of severe allergy (requiring hospital care) or history of severe asthma
- Subject has a history of malignant cancer, except the following adequately treated cancers: basal cell carcinoma, or dermatological squamous cell carcinoma.
- Subject was administered with another investigational drug or vaccine within 30 days prior to the screening visit or is participating in any other study.
- Subject has a known hypersensitivity to imiquimod.
- Subject has a history of severe reaction to any drug or vaccination.
- Subject has a medical condition with clinical and/or biological consequences judged by the Investigator incompatible with vaccination(s).
- Subject has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV).
- Subject has a symptomatic vaginal or genital infection
- Subject has a history of or currently active genital herpes disease.
- Subject is pregnant or is breastfeeding.
- Subject has a positive serum human chorionic gonadotrophin (HCG) result at enrolment.
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
France10 sites
CHU Amiens Hopital Sud
Amiens
Hôpital Saint Jacques
Besançon
GORH, CHU Estaing
Clermont-Ferrand
CHU Dijon
Dijon
Hôpital Jeanne de Flandre CHU de Lille
Lille
CHU de Nîmes - Hopital Universitaire Caremeau
Nîmes
Centre d'Investigation Clinique de Vaccinologie Cochin Pasteur (CIC BT505)
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite
CHU de Reims Institut Alix de Champagne
Reims
Hôpital de Hautepierre
Strasbourg
Spain10 sites
Hospital Clinic Dept of Obstetrics and Gynecology C/ Villarroel Unidad de Ginecología Oncológica, Instituto Clínico de Ginecología y Obstetricia y Neonatología (ICGON), Hospital Clínic, Instituto de Investigaciones Biomédi
Barcelona
Hospital del Mar
Barcelona
Hospital Universitari Vall D Hebron
Barcelona
Institut Catala d'Oncologia L'Hopitalet de Llobregat
Barcelona
Clinica Ginecologica Ceoga, Clinic/Outpatient Facility
Lugo
Hospital Clínico San Carlos
Madrid
Hospital La Paz de Madrid
Madrid
Hospital Universitario "12 de Octubre"
Madrid
Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil
Málaga
Hospital Sagrado Corazón de Sevilla
Seville
Germany6 sites
Charité - Universitätsmedizin Berlin Hospital
Berlin
Universitätsklinikum Erlangen Hospital
Erlangen
Elisabeth Krankenhaus Essen GmbH - Clinic/Outpatient Facility
Essen
Klinikum der Friedrich Schiller Universität Jena Hospital
Jena
LMU Klinikum der Universität- Hospital
München
Klinikum Wolfsburg Hospital
Wolfsburg
United Kingdom5 sites
Dumfries and Galloway Royal Infirmary Hospital
Dumfries
Liverpool - GUM - Liverpool Centre for Sexual Health
Liverpool
St Mary's Hospital
London
Academic O&G University of Manchester Research - St Mary's Hospital
Manchester
The Centre for Immunology and Infection Hull York Medical School University of York
York
Belgium4 sites
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute (VAXINFECTIO) Faculty of Medicine University of Antwerp Belgium
Antwerp
Grand Hôpital de Charleroi Site Notre-Dame
Charleroi
University Hospitals Leuven
Leuven
Regionaal Ziekenhuis Heilig Hart Tienen Hospital
Tienen, Vlaams Brabant
Finland3 sites
Helsinki University Central Hospital
Helsinki
Kuopio University Hospital
Kuopio
Tampereen yliopistollinen sairaala Hospital
Tampere
Netherlands2 sites
Center Gynaecological Oncology Amsterdam AMC, NKI-AVL, VUmc
Amsterdam
St. Antonius Ziekenhuis Hospital
Nieuwegein
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate ProCervix Efficacy to Clear HPV 16 and HPV 18 Infection in Women With Normal Cytology or ASCUS/LSIL
Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential.
This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).
Read more
ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant.
The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.
- Conditions
- Genital Infection Viral, HUMAN PAPILLOMA VIRUS
- Being tested
- ProCervix, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProCervixBiological
ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod
PlaceboBiological
Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod
| Study group | Role | What they receive |
|---|---|---|
| HPV therapeutic vaccine | Experimental | ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod Receives: Biological: ProCervix |
| Placebo matching ProCervix | Placebo comparator | Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of HPV 16 and HPV 18 infection at Month 12 using a type specific, sensitive and quantitative HPV PCR assay.
Measured: month 12
Secondary outcomes (1)
Clearance of HPV 16 and HPV 18 infection.
Measured: Month 6, 15, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Infection ViralStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genticel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957878
- Sponsor's protocol ID
- PC10VAC02
- Acronym
- RHEIA-VAC
- Status last verified
- Dec 2016
- First submitted
- 4 Oct 2013
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate ProCervix Efficacy to Clear HPV 16 and HPV 18 Infection in Women With Normal Cytology or ASCUS/LSIL
- ClinicalTrials.gov ID
- NCT01957878
- Acronym / sponsor ID
- RHEIA-VAC / PC10VAC02
- Conditions
- Genital Infection Viral, HUMAN PAPILLOMA VIRUS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- GenticelIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Oct 2013 (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.
Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential.
This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).
ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant.
The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV therapeutic vaccine | Experimental | Biological: ProCervixProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod |
| Placebo matching ProCervix | Placebo comparator | Biological: PlaceboPlacebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- A subject will be eligible for inclusion in this study if the following criteria apply:
Key exclusion criteria (20 listed)
- Subject has a current acute or chronic disease, other than infection with HPV, which would be expected to interfere with the planned evaluations of response
- Subject has vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators (SERMs).
- Subject has prior exposure to HPV prophylactic vaccine or subject has participated in the past in another vaccination clinical trial related to infection with HPV
- Current high grade lesions or history of untreated high grade cervical lesion (either CIN2 or CIN3).
- Subject has current or a history of cancer of the cervix.
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 |
|---|---|---|
| ProCervixProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod | Biological | HPV therapeutic vaccine |
| PlaceboPlacebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod | Biological | Placebo matching ProCervix |
Primary outcome
Clearance of HPV 16 and HPV 18 infection at Month 12 using a type specific, sensitive and quantitative HPV PCR assay.
Time frame: month 12
1 secondary outcome
Clearance of HPV 16 and HPV 18 infection.
Time frame: Month 6, 15, 18, 24
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 2 Dec 2016.
Related trials for Genital Infection Viral
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ProCervix in people with Genital Infection Viral and HUMAN PAPILLOMA VIRUS, run by Genticel at 40 sites in 7 countries.
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 9 inclusion and 20 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 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France, Spain, Germany, United Kingdom, Belgium and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clearance of HPV 16 and HPV 18 infection at Month 12 using a type specific, sensitive and quantitative HPV PCR assay. (time frame: month 12). 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 2 Dec 2016.