Clinical Trials List
Protocol NumberPVX2TACIN17368
NCT Number(ClinicalTrials.gov Identfier)NCT03911076
2018-10-01 - 2021-11-30
Phase II
Recruiting1
ICD-10C53.9
Malignant neoplasm of cervix uteri, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9180.9
Malignant neoplasm of cervix uteri, unspecified
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)
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Trial Applicant
QPS
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Sponsor
PapiVax Biotech, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Linkou Chang Gung Medical Foundation
Taiwan National PI
林政道
Co-Principal Investigator
- Angel Chao Division of Obstetrics & Gynecology
- 容世明 Division of Pediatrics
- Huei-Jean Huang Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
AS-CUS/ASC-H Atypical Squamous Cells, Cannot Rule Out High-Grade Squamous Intra-Epithelial Lesion/LSIL
Objectives
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
Test Drug
pNGVL4a-Sig/E7(detox)/HSP70；TA-CIN
Active Ingredient
pNGVL4a-Sig/E7(detox)/HSP70
TA-CIN
TA-CIN
Dosage Form
injection
injection
injection
Dosage
3.6 mg
0.1235 mg
0.1235 mg
Endpoints
Primary Outcome Measures :
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
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 :
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
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
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
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 :
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
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
Inclution Criteria
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
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
Exclusion Criteria
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.
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.
The Estimated Number of Participants
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Taiwan
92 participants
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Global
122 participants
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