Study of Treatment for HPV16+ ASC-US or LSIL

Phase 1

Recruiting

• Conditions: ASC-US; LSIL

• Registration Number: NCT03913117
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-4-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Patients with persistent (>6 month period) ASC-US/LSIL determined by cervical<br> cytology at study entry (ThinPrep with imaging)<br><br> 2. Patients whose cytologic samples are persistent (>6 month period) HPV16+ by Roche<br> Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV<br> genotyping test at study entry. Co-infections with HPV types other than HPV16 are<br> permissible for study entry.<br><br> 3. Age = 19 years<br><br> 4. Baseline Eastern Cooperative Oncology Group<br><br> 5. Patients must have adequate organ function at the time of enrollment as defined by<br> the following parameters:<br><br> - White blood cell count > 3,000<br><br> - Absolute lymphocyte number > 500<br><br> - Absolute neutrophil count > 1,000<br><br> - Platelets > 90,000<br><br> - Hemoglobulin > 9<br><br> - Total bilirubin <3 X the institutional limit of normal<br><br> - AST(SGOT)/ALT(SGPT) <3 X the institutional limit of normal<br><br> - Creatinine < 2.5X the institutional limit of normal<br><br> 6. Women of child-bearing potential must agree to use two forms of contraception<br> (hormonal and barrier) prior to study entry and for 3 months after study completion.<br><br> 7. Ability to understand and the willingness to sign a written informed consent<br> document.<br><br> 8. Subject is able to adhere to the study visit schedule and other protocol<br> requirements.<br><br>Exclusion Criteria:<br><br> 1. Patients with ASC-US/LSIL determined by cervical cytology at study entry that are<br> HPV16 negative.<br><br> 2. Histologic evidence of CIN2+<br><br> 3. Patients with a diagnosis of immunosuppression or prolonged, active use of<br> immunosuppressive medications such as steroids.<br><br> 4. Prior vaccination with any HPV antigen (prophylactic or therapeutic).<br><br> 5. Patients who are receiving any other investigational agents within 28 days prior to<br> the first dose.<br><br> 6. Patients with an uncontrolled intercurrent illness including, but not limited to,<br> ongoing or active infection, symptomatic congestive heart failure, unstable angina<br> pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would<br> limit compliance with study requirements.<br><br> 7. Patients with a history of autoimmune disease such as multiple sclerosis, exclusive<br> of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.<br><br> 8. Patients with a history of allergic reactions attributed to compounds used in agent<br> preparation.<br><br> 9. Patients who are pregnant or breast feeding.<br><br> 10. Patient with active or chronic infection of HIV, HCV, or HBV.<br><br> 11. Patients who have had a prior LEEP or cervical conization procedure.<br><br> 12. History of prior malignancy permitted if patient has been disease free for = 5<br> years; however individuals with completely resected basal cell or squamous cell<br> carcinoma of the skin within this interval may be enrolled.<br><br> 13. Inability to understand or unwillingness to sign an informed consent document.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination;Dose finding;Safety and feasibility of PVX-6 vaccination

Secondary Outcome Measures

Name	Time	Method
HPV16 antibody response;HPV16 CD8 T cell response;HPV16 L2E7E6 T cell proliferative response;Clearance of HPV16;Cytologic clearance