* 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
Patients with human papillomavirus type 16 (HPV16) infection and low-grade cervical dysplasia \[low-grade squamous intraepithelial lesion (LSIL)/CIN1\] or atypical squamous cells \[atypical squamous cells of undetermined significance (ASC-US)/atypical squamous cells- cannot exclude high-grade squamous intraepithelial lesion (ASC-H)\] require active surveillance for disease progression. A safe and effective immunotherapy to clear HPV16 is an unmet medical need. This study (NCT03911076) is a randomized double-blind, placebo-controlled phase II trial of PVX2 \[vaccination twice with HPV16-targeting pNGVL4a-Sig/E7(detox)/HSP70 plasmid and once with the HPV16 L2E7E6 fusion protein "TA-CIN"\] as immunotherapy for patients with HPV16+ ASC-US, ASC-H, or LSIL/CIN1. The primary objective of this cohort is to determine the safety and tolerability of PVX2 in three monthly immunizations. Subjects are confirmed to have HPV16 infection and LSIL/CIN1, ASC-US, or ASC-H. Adverse events are evaluated using Common Terminology Criteria for Adverse Events v5.0. HPV typing by HPV16 18/45 Aptima Assay is performed at baseline, month 6, and month 12, with simultaneous cytology analysis. Cervical biopsies and endocervical curettage are performed at baseline and month 6. In a safety run-in cohort 12 eligible patients are enrolled prior to the randomized phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
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
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
Time frame: 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
Time frame: 6 months
Percent of patients that have cleared HPV16 at Month 12
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
Time frame: 12 months
Percent of patients that have normal cytology at Month 6
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
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Corpus Christi Women's Clinic (Elligo Health Research, Inc.)
Corpus Christi, Texas, United States
MacArthur Medical Center
Irving, Texas, United States