Actively Recruiting

Phase 1
Age: 19Years +
FEMALE
NCT03913117

Study of Treatment for HPV16+ ASC-US or LSIL

Led by University of Alabama at Birmingham · Updated on 2025-06-26

30

Participants Needed

2

Research Sites

216 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

J

Johns Hopkins University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Study of Treatment for HPV16+ ASC-US or LSIL

Who Can Participate

Age: 19Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with persistent (>6 months) ASC-US or LSIL determined by cervical cytology at study entry
  • Patients with persistent (>6 months) HPV16 positive cytologic samples by approved HPV genotyping tests at study entry
  • Age 19 years or older
  • Baseline Eastern Cooperative Oncology Group status required
  • Adequate organ function including white blood cell count > 3,000, absolute lymphocyte number > 500, absolute neutrophil count > 1,000, platelets > 90,000, hemoglobin > 9, total bilirubin < 3 times institutional limit, AST/ALT < 3 times institutional limit, and creatinine < 2.5 times institutional limit
  • Women of child-bearing potential must agree to use two forms of contraception before enrollment and for 3 months after study completion
  • Ability to understand and willing to sign informed consent
  • Ability to adhere to study visit schedule and protocol requirements
Not Eligible

You will not qualify if you...

  • Patients with ASC-US or LSIL who are HPV16 negative at study entry
  • Histologic evidence of cervical intraepithelial neoplasia grade 2 or higher (CIN2+)
  • Diagnosis of immunosuppression or prolonged active use of immunosuppressive medications such as steroids
  • Prior vaccination with any HPV antigen (prophylactic or therapeutic)
  • Receiving other investigational agents within 28 days prior to study start
  • Uncontrolled intercurrent illnesses including active infections, symptomatic heart failure, unstable angina, cardiac arrhythmias, or psychiatric/social conditions limiting study compliance
  • History of autoimmune diseases such as multiple sclerosis (excluding thyroiditis, psoriasis, Sjogren's, inflammatory bowel disease)
  • History of allergic reactions to compounds used in study agents
  • Pregnant or breastfeeding women
  • Active or chronic infection with HIV, HCV, or HBV
  • Prior LEEP or cervical conization procedures
  • History of prior malignancy unless disease free for 5 years; resected basal or squamous cell carcinoma of skin allowed
  • Inability or unwillingness to understand or sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

UAB | The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

Actively Recruiting

2

Johns Hopkins University

Baltimore, Maryland, United States, 21231

Actively Recruiting

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Research Team

W

Wendy Wu, MS

CONTACT

Y

Yung-Nien Chang, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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