RecruitingPhase 1NCT03913117

Study of Treatment for HPV16+ ASC-US or LSIL

Phase I Clinical Trial Assessing the Safety and Feasibility of Intramuscular pNGVL4aCRTE6E7L2 and TA-CIN Administration for the Treatment of Patients With Persistent HPV16+ ASC-US or LSIL


Sponsor

University of Alabama at Birmingham

Enrollment

30 participants

Start Date

Jul 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine


Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a treatment can clear a persistent HPV16 infection — a specific strain of human papillomavirus linked to cervical cancer — in women with mildly abnormal Pap smear results that have persisted for more than 6 months. **You may be eligible if...** - You are 19 or older - You have had mildly abnormal Pap smear results (ASC-US or LSIL) for more than 6 months - Your cervical samples have tested positive for HPV16 for more than 6 months - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your HPV infection or abnormal Pap results have been present for less than 6 months - You are pregnant or planning to become pregnant during the study - Your blood or organ function levels fall below required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALpNGVL4aCRTE6E7L2

Naked pNGVL4aCRTE6E7L2 DNA plasmid

BIOLOGICALTA-CIN

TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.


Locations(2)

UAB | The University of Alabama at Birmingham

Birmingham, Alabama, United States

Johns Hopkins University

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT03913117