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Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL (PVX-2)

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ClinicalTrials.gov Identifier: NCT03911076
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
PapiVax Biotech, Inc.

Brief Summary:
  • 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

Condition or disease Intervention/treatment Phase
ASC-US ASC-H Atypical Squamous Cells, Cannot Rule Out High-Grade Squamous Intra-Epithelial Lesion LSIL Biological: PVX-2 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Safety run-in followed by randomized double-blind, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Safety run-in is open label (no control), followed by randomized double-blind, placebo-controlled study
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PVX-2
Prime: 3 mg pNGVL4a-Sig/E7(detox)/HSP70 DNA Boost: 0.1 mg TA-CIN protein
Biological: PVX-2
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)
Other: Placebo
PBS and PGC




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients with cervical cytologic diagnosis of ASC-US, ASC-H, or LSIL
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female subjects age 25-70 years with confirmation of ASC-US, ASC-H, or LSIL by liquid-based cytology
  2. HIV uninfected
  3. Patients whose cytologic specimen is HPV16+ by Aptima HPV 16 18/45 Genotype Assay
  4. Body Mass Index ≤ 32 kg/m2
  5. Hepatitis B surface antigen negative
  6. Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV positive
  7. 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
  8. 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.
  9. 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.
  10. Histologic diagnosis of <CIN2 upon screening colposcopic examination with mandatory ECC, and cervical biopsy(ies) as clinically indicated.

Exclusion Criteria:

  1. Patients who are attempting pregnancy within 6 months, pregnant, or breastfeeding.
  2. Patients with immunodeficiency, or treatment with immunosuppressive medications
  3. Administration of any blood product within 3 months of enrollment.
  4. Administration of any licensed vaccine within 2 weeks of enrollment (4weeks for measles vaccine)
  5. Participation in a study with an investigational compound or device within 30 days of signing informed consent.
  6. History of seizures (unless seizure free for 5 years)
  7. Patients with positive serological test for human immunodeficiency virus (HIV).
  8. Previous cancer history within the past 5 years.
  9. Patients who have had chemotherapy, radiation, biological cancer therapy, or other investigational agents within 28 days prior to the first dose of study drug.
  10. Patients who have had surgery within 28 days, excluding minor procedures (dental work, skin biopsy, etc).
  11. 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.
  12. 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).
  13. 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
  14. Previous cervical conization or LEEP procedure or previous total hysterectomy due to cervical lesions at enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911076


Contacts
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Contact: Wendy Wu, MS +886282268451 wendy@papivax.com.tw

Locations
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United States, Florida
Miami Research Associates Recruiting
Miami, Florida, United States, 33143
Contact: Lissette Molina, MD         
Health Awareness, Inc. Recruiting
Port Saint Lucie, Florida, United States, 33458
Contact: Allison Blomer, MD         
United States, Texas
Corpus Christi Women's Clinic (Elligo Health Research, Inc.) Recruiting
Corpus Christi, Texas, United States, 78412
Principal Investigator: Charles Kirkham, MD         
Sponsors and Collaborators
PapiVax Biotech, Inc.
Parexel

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Responsible Party: PapiVax Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03911076     History of Changes
Other Study ID Numbers: PVX2TACIN17368
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atypical Squamous Cells of the Cervix
Squamous Intraepithelial Lesions of the Cervix
Uterine Cervical Dysplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female