Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL

Stopped early · Phase 2 · Has a placebo group

Conditions studied: ASC-US, ASC-H, LSIL

In brief

* 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

Key facts

Study ID

NCT03911076

Run by

PapiVax Biotech, Inc.

People needed

16

Starts

2019-05-22

Expected to finish

2022-06-08

Last updated by the study team

2024-06-17

Who can join

Age: 25 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Health Awareness, Inc. — Port Saint Lucie, Florida, United States
• University Hospital, Rutgers New Jersey Medical School — Newark, New Jersey, United States
• Obstetrics & Gynecology Associates, Inc. — Fairfield, Ohio, United States
• Austin Area Obstetrics, Gynecology, and Fertility — Austin, Texas, United States
• Corpus Christi Women's Clinic (Elligo Health Research, Inc.) — Corpus Christi, Texas, United States
• MacArthur Medical Center — Irving, Texas, United States

Full record on ClinicalTrials.gov

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