Cervical Intraepithelial NeoplasiaPhase 1NCT01880411
Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity PEK Fusion Protein Vaccine
A Phase 1 study testing PEK Fusion Protein Vaccine in people with Cervical Intraepithelial Neoplasia, run by HealthBanks Biotech Co., Ltd..
Trial summary
Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL. PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (LSIL) or… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- PEK Fusion Protein Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Female age 18 to 45 years
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
- LSIL or HSIL on Papanicolaou (PAP) smear within the prior 6-8 weeks
- Normal electrocardiogram (ECG), laboratory values (chemistry, complete blood count) and urinalysis, as judged by Grade 0-1 as per National Cancer Institute Common Toxicity Criteria (NCI-CTC) performed up to 30 days prior to administration of study treatment.
- Body mass index (BMI) ≤32 kg/m2
- Women of child-bearing potential (WOCBP) agree to use two forms of medically effective contraception (e.g. hormonal contraception, intrauterine device, barrier method, spermicide, etc…) during the study and for at least 12 weeks following the completion of treatment. Patients agree to inform the investigator immediately if they become pregnant during the study or within 12 weeks following completion of treatment and to provide information about the pregnancy, delivery and health of the infant until the age of one month.
- Able and willing to comply with all study procedures
Who cannot join
- Active infection with herpes simplex virus (HSV)
- Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus (HCV), or Hepatitis B surface antigen (HBsa)
- Pregnant or breast-feeding
- History of any prior cervical surgical treatment
- History of any active autoimmune disease or current medical condition requiring the use of systemic or topical corticosteroids (excluding steroid containing eye drops or inhaled steroids) or other immunosuppressive agents within 4 weeks prior to enrollment
- History of cancer (excluding basal cell carcinoma of the skin)
Show all 14Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Administration of any blood product within 3 months of enrollment
- Administration of any vaccine within 6 weeks of enrollment
- Active infection requiring antimicrobial treatment
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- Any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, anticoagulants or platelet inhibitors
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
- Any condition which, in the opinion of the investigator, would limit the evaluation of the patient.
About this study
Official title: Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine (PEK + GPI-0100) in Patients With LSIL or HSIL
Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL.
PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial lesions (HSIL) of the cervix and induces a measurable immune response.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- PEK Fusion Protein Vaccine
- Keywords
- PEK fusion protein Healthbanks
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEK Fusion Protein VaccineBiological
PEK (PE-E7-K3), a recombinant protein combined with GPI-0100 adjuvant
| Study group | Role | What they receive |
|---|---|---|
| PEK Fusion Protein Vaccine | Experimental | PEK Fusion Protein Vaccine Injection 0.1mg, 0.3mg and 1.2mg One injection at one week intervals Receives: Biological: PEK Fusion Protein Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthBanks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina S Chu, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880411
- Sponsor's protocol ID
- HBPEKVPI001
- Status last verified
- Jun 2013
- First submitted
- 13 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine (PEK + GPI-0100) in Patients With LSIL or HSIL
- ClinicalTrials.gov ID
- NCT01880411
- Acronym / sponsor ID
- HBPEKVPI001
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- PEK fusion protein Healthbanks
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- HealthBanks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 19 Jun 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.
Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity of a Three Dose Regimen of Escalating Doses of PEK Fusion Protein Vaccine in Women with LSIL or HSIL.
PEK fusion protein vaccine (PEK + GPI-0100) is safe and well tolerated in patients with low-grade squamous intraepithelial lesions (LSIL) or high grade squamous intraepithelial lesions (HSIL) of the cervix and induces a measurable immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEK Fusion Protein Vaccine | Experimental | Biological: PEK Fusion Protein VaccinePEK Fusion Protein Vaccine Injection 0.1mg, 0.3mg and 1.2mg One injection at one week intervals |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female age 18 to 45 years
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
- LSIL or HSIL on Papanicolaou (PAP) smear within the prior 6-8 weeks
- Normal electrocardiogram (ECG), laboratory values (chemistry, complete blood count) and urinalysis, as judged by Grade 0-1 as per National Cancer Institute Common Toxicity Criteria (NCI-CTC) performed up to 30 days prior to administration of study treatment.
Key exclusion criteria (14 listed)
- Active infection with herpes simplex virus (HSV)
- Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus (HCV), or Hepatitis B surface antigen (HBsa)
- Pregnant or breast-feeding
- History of any prior cervical surgical treatment
- History of any active autoimmune disease or current medical condition requiring the use of systemic or topical corticosteroids (excluding steroid containing eye drops or inhaled steroids) or other immunosuppressive agents within 4 weeks prior to enrollment
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 |
|---|---|---|
| PEK Fusion Protein VaccinePEK (PE-E7-K3), a recombinant protein combined with GPI-0100 adjuvant | Biological | PEK Fusion Protein Vaccine |
Primary outcome
Number of participants with adverse events.
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
Christina S Chu, MD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEK Fusion Protein Vaccine in people with Cervical Intraepithelial Neoplasia, run by HealthBanks Biotech Co., Ltd..
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 14 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: status not confirmed, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Number of participants with adverse events. (time frame: 6 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 19 Jun 2013.