Recruiting
Phase 1

HPV Treatment

Sponsor:

University of Alabama at Birmingham

Code:

NCT03913117

Conditions

ASC-US

LSIL

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Interventions

pNGVL4aCRTE6E7L2

TA-CIN

Study Details

Brief 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

Conditions

ASC-US

LSIL

Study ID

NCT03913117

Start date

Jul 10, 2023

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients with persistent (>6 month period) ASC-US/LSIL determined by cervical cytology at study entry (ThinPrep with imaging)
2. Patients whose cytologic samples are persistent (>6 month period) HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test at study entry. Co-infections with HPV types other than HPV16 are permissible for study entry.
3. Age ≥ 19 years
4. Baseline Eastern Cooperative Oncology Group
5. Patients must have adequate organ function at the time of enrollment as defined by the following parameters:

  • White blood cell count > 3,000
  • Absolute lymphocyte number > 500
  • Absolute neutrophil count > 1,000
  • Platelets > 90,000
  • Hemoglobulin > 9
  • Total bilirubin <3 X the institutional limit of normal
  • AST(SGOT)/ALT(SGPT) <3 X the institutional limit of normal
  • Creatinine < 2.5X the institutional limit of normal
6. Women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier) prior to study entry and for 3 months after study completion.
7. Ability to understand and the willingness to sign a written informed consent document.
8. Subject is able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Patients with ASC-US/LSIL determined by cervical cytology at study entry that are HPV16 negative.
2. Histologic evidence of CIN2+
3. Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids.
4. Prior vaccination with any HPV antigen (prophylactic or therapeutic).
5. Patients who are receiving any other investigational agents within 28 days prior to the first dose.
6. 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.
7. Patients with a history of autoimmune disease such as multiple sclerosis, exclusive of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.
8. Patients with a history of allergic reactions attributed to compounds used in agent preparation.
9. Patients who are pregnant or breast feeding.
10. Patient with active or chronic infection of HIV, HCV, or HBV.
11. Patients who have had a prior LEEP or cervical conization procedure.
12. History of prior malignancy permitted if patient has been disease free for ≥ 5 years; however individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.
13. Inability to understand or unwillingness to sign an informed consent document.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: pNGVL4aCRTE6E7L2 0.3mg dose

Low dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

experimental: pNGVL4aCRTE6E7L2 1 mg dose

Intermediate dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

experimental: pNGVL4aCRTE6E7L2 3 mg dose

High dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

experimental: PVX-6

Selected dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0 and 4, and the TA-CIN protein is administered by intramuscular injection at week 8.

Interventions

pNGVL4aCRTE6E7L2

Naked pNGVL4aCRTE6E7L2 DNA plasmid

TA-CIN

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

Primary outcome measure

  • Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination [ Time Frame: 12 months ]
  • Dose finding [ Time Frame: 12 months ]
  • Safety and feasibility of PVX-6 vaccination [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

UAB | The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Kimberly Levinson, M.D.

klevins1@jhmi.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • HPV16

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-15.