- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03911076
Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL (PVX-2)
April 19, 2022 updated by: PapiVax Biotech, Inc.
A Randomized Double-Blind, Placebo-controlled Phase II Trial With Safety Run-In of Intramuscular pNGVL4a-Sig/E7(Detox)/HSP70 and TA-CIN for the Treatment of Patients With HPV16+ Atypical Squamous Cells of Undetermined Significance (ASC-US) or Cannot Exclude High Grade SIL (ASC-H) Cytology or Low-grade Squamous Intraepithelial Lesion (LSIL)
- To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen
- To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
134
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Muchou J Ma, MD
- Phone Number: +1 407 971 1487
- Email: joe@papivax.com.tw
Study Locations
-
-
Florida
-
Port Saint Lucie, Florida, United States, 33458
- Recruiting
- Health Awareness, Inc.
-
Contact:
- Allison Blomer, MD
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- Recruiting
- University Hospital, Rutgers New Jersey Medical School
-
Contact:
- Mark H Einstein, MD
- Phone Number: 973-972-2714
-
Principal Investigator:
- Mark H Einstein, MD
-
-
Ohio
-
Fairfield, Ohio, United States, 45014
- Recruiting
- Obstetrics & Gynecology Associates, Inc.
-
Contact:
- Kimberly A Bonar, MD
- Phone Number: 833-740-0315
-
Contact:
- Kayla Rauch
- Phone Number: 513-275-5322
-
Principal Investigator:
- Kimberly A Bonar, MD
-
-
Texas
-
Austin, Texas, United States, 78758
- Recruiting
- Austin Area Obstetrics, Gynecology, and Fertility
-
Contact:
- Mark Akin, MD
- Phone Number: 512-652-7001
-
Principal Investigator:
- Mark Akin, MD
-
Corpus Christi, Texas, United States, 78412
- Recruiting
- Corpus Christi Women's Clinic (Elligo Health Research, Inc.)
-
Principal Investigator:
- Charles Kirkham, MD
-
Irving, Texas, United States, 75062
- Recruiting
- MacArthur Medical Center
-
Contact:
- Jeff M Livingston, MD
- Phone Number: 972-256-3700
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female subjects age 25-70 years with confirmation of ASC-US, ASC-H, or LSIL by liquid-based cytology
- HIV uninfected
- Patients whose cytologic specimen is HPV16+ by Aptima HPV 16 18/45 Genotype Assay
- Body Mass Index ≤ 32 kg/m2
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV positive
- Patients who are able and willing to comply with all study procedures and voluntarily sign an informed consent form, and with anticipated availability for the planned follow-up period of one year
- Patients who are of childbearing potential agree to remain sexually abstinent, use methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 6 months.
- Patients must have adequate organ function at the time of enrollment as defined by the following parameters: white blood cell count >3,000/mcL; lymphocyte number >500/mcL; absolute neutrophil count >1,000/mcL; platelets >90,000/mcL; hemoglobin >9 g/dL; total bilirubin <3 X the institutional limit of normal; aspartate aminotransferase (AST [SGOT]) / alanine aminotransferase (ALT [SGPT]) <3 X the institutional limit of normal; creatinine <2.5X the institutional limit of normal.
- Histologic diagnosis of <CIN2 upon screening colposcopic examination with mandatory ECC, and cervical biopsy(ies) as clinically indicated.
Exclusion Criteria:
- Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.
- Patients with immunodeficiency, or treatment with immunosuppressive medications
- Administration of any blood product within 3 months of enrollment.
- Administration of any licensed vaccine within 2 weeks of enrollment (4weeks for measles vaccine)
- Participation in a study with an investigational compound or device within 30 days of signing informed consent.
- History of seizures (unless seizure free for 5 years)
- Patients with positive serological test for human immunodeficiency virus (HIV).
- Previous cancer history within the past 5 years.
- Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug.
- Patients who have had surgery within 28 days, excluding minor procedures (dental work, skin biopsy, etc).
- Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing, or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis).
- Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies; patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids
- Previous cervical conization or LEEP procedure or previous total hysterectomy due to cervical lesions at enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PVX-2
Prime: 3 mg pNGVL4a-Sig/E7(detox)/HSP70 DNA Boost: 0.1 mg TA-CIN protein
|
pNGVL4a-Sig/E7(detox)/HSP70 (naked DNA plasmid priming vaccine) TA-CIN (HPV16 L2E7E6 fusion protein booster vaccine)
|
Placebo Comparator: Placebo
Prime: PBS (Phosphate Buffered Saline) Boost: PGC (Phosphate Glycine Cysteine Buffer)
|
PBS and PGC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
Time Frame: 12 months
|
To evaluate the safety and tolerability of the dual IM pNGVL4a Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen
|
12 months
|
Percent of patients that have cleared HPV16 at Month 6
Time Frame: 6 months
|
To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on Human Papillomavirus (HPV) 16 clearance by Month 6
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients that have cleared HPV16 at Month 12
Time Frame: 12 months
|
To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on maintenance of Human Papillomavirus (HPV) 16 clearance by Month 12
|
12 months
|
Percent of patients that have normal cytology at Month 6
Time Frame: 6 months
|
To evaluate the efficacy of dual IM pNGVL4a-Sig/E7(detox)/HSP70 DNA and single IM TA-CIN immunization regimen on regression to cytology with no evidence of intraepithelial lesion or malignancy (NILM) at Month 6
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2019
Primary Completion (Anticipated)
September 30, 2023
Study Completion (Anticipated)
January 30, 2024
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 9, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
April 20, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PVX2TACIN17368
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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