- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065973
An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101
An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101 in Subjects With Cervical Intraepithelial Neoplasia (CIN) and High-risk Human Papillomavirus (HPV) Infection
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Port Jefferson, New York, United States, 11777
- Suffolk Obstetrics & Gynecology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent prior to initiation of any study-related procedures;
- Nonlactating female between the ages of 21 to 65 years, inclusive;
- Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contraception (defined as 2 concurrent methods of contraception, 1 of which is a barrier method) and agrees to continue using effective contraception throughout the duration of the study;
- Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits);
- Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL) within 4 months prior to screening Visit 1;
- History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy, within 12 weeks prior to administration of first study vaccination (CIN 2/3 subjects will not be eligible);
- For the diagnosis of CIN1, has a documented satisfactory colposcopy, ie, the entire lesion as well as the entire squamocolumnar junction is visualizible by colposcopy;
- Confirmed high-risk HPV infection by a commercially available high-risk DNA assay (eg, Hybrid Capture II [Qiagen]);
Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1):
- Bone marrow function: absolute neutrophil count ≥1,500/µL, and platelets ≥ 100,000/ µL;
- Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN);
- Hepatic function: total bilirubin ≤ 1.5 x ULN (Common Terminology Criteria for AEs [CTCAE] v4.0 grade 1) except patients with Gilbert's disease (up to 5.0 mg/dL). Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN.
- Normal Cardiac function: as assessed by history and physical exam.
Exclusion Criteria:
- Atypical endometrial or glandular cells or evidence of invasive cervical carcinoma on cervical biopsy;
- Previous history of cancer, other than adequately treated basal cell or Stage 1 squamous cell carcinoma of the skin;
- Current recognized immunodeficiency disease, including infection with HIV, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies.
- Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor]) within 30 days prior to administration of the first study vaccination;
- Serious, concomitant disorder, including active systemic infection requiring treatment, in the opinion of the investigator;
Currently receiving or has received treatment with systemic steroids in the following dosages within 30 days prior to administration of the first study vaccination.
- Chronic or long-term corticosteroids: ≥0.5 mg/kg/day of oral prednisolone or equivalent
- Sporadic corticosteroids: ≥1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days
- Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable;
- Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results;
- Participation in another investigational study concurrently or use of another investigational drug within 6 months prior to administration of the first study vaccination;
- Previously enrolled in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Cohort 1 (Low Dose)
The group will receive the lowest dose of the vaccine
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ACTIVE_COMPARATOR: Cohort 2 (Mid Dose)
The Group will receive the middle dose of the vaccine
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ACTIVE_COMPARATOR: Cohort 3 (High Dose)
The Group will receive the highest dose of vaccine to be tested
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation or determination of adverse events following vaccination
Time Frame: Days 1-133
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Days 1-133
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U10-02-11-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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