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

NCT03911076 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: PVX2TACIN17368
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

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

Conditions

ASC-US; ASC-H; LSIL

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

  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

  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 Outcomes (2)

• Percent of patients that have cleared HPV16 at Month 12

  12 months

• Percent of patients that have normal cytology at Month 6

  6 months

Study Arms (2)

PVX-2

EXPERIMENTAL

Prime: 3 mg pNGVL4a-Sig/E7(detox)/HSP70 DNA Boost: 0.1 mg TA-CIN protein

Biological: PVX-2

Placebo

PLACEBO COMPARATOR

Prime: PBS (Phosphate Buffered Saline) Boost: PGC (Phosphate Glycine Cysteine Buffer)

Other: Placebo

Interventions

PVX-2 BIOLOGICAL

pNGVL4a-Sig/E7(detox)/HSP70 (pBI-1, naked DNA plasmid priming vaccine) TA-CIN (HPV16 L2E7E6 fusion protein booster vaccine)

PVX-2

Placebo OTHER

PBS and PGC

Placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Gender Eligibility Details: Patients with cervical cytologic diagnosis of ASC-US, ASC-H, or LSIL
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• PapiVax Biotech, Inc.: lead
• Parexel: collaborator

Study Sites (6)

Health Awareness, Inc.

Port Saint Lucie, Florida, 33458, United States

Location

University Hospital, Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Obstetrics & Gynecology Associates, Inc.

Fairfield, Ohio, 45014, United States

Location

Austin Area Obstetrics, Gynecology, and Fertility

Austin, Texas, 78758, United States

Location

Corpus Christi Women's Clinic (Elligo Health Research, Inc.)

Corpus Christi, Texas, 78412, United States

Location

MacArthur Medical Center

Irving, Texas, 75062, United States

Location

Related Publications (1)

• Einstein MH, Roden RBS, Ferrall L, Akin M, Blomer A, Wu TC, Chang YN. Safety Run-in of Intramuscular pNGVL4a-Sig/E7(detox)/HSP70 DNA and TA-CIN Protein Vaccination as Treatment for HPV16+ ASC-US, ASC-H, or LSIL/CIN1. Cancer Prev Res (Phila). 2023 Apr 3;16(4):219-227. doi: 10.1158/1940-6207.CAPR-22-0413.

  PMID: 36607735 RESULT

Related Links

• Study report

MeSH Terms

Conditions

Atypical Squamous Cells of the Cervix

Condition Hierarchy (Ancestors)

Uterine Cervical Dysplasia; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Einstein, MD, MS

  Professor and Chairman, Dept. of OBS&GYN, Rutgers New Jersey Medical School, Newark, NJ 07101

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Safety run-in is open label (no control), followed by randomized double-blind, placebo-controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Safety run-in followed by randomized double-blind, placebo-controlled study

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 10, 2019
• Study Start: May 22, 2019
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)