Study of Treatment for HPV16+ ASC-US or LSIL (PVX-6)

May 12, 2026 updated by: Rebecca Arend, University of Alabama at Birmingham

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives

  1. To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL.
  2. To determine the appropriate intra-muscular injection dose of pNGVL4aCRTE6E7L2 DNA vaccine as determined by toxicity and immunogenicity for a subsequent phase II clinical trial.
  3. To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine prime, TA-CIN protein vaccine boost in patients with persistent HPV16+ ASC-US/LSIL.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pNGVL4aCRTE6E7L2 0.3mg dose
Low dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.
Biological: pNGVL4aCRTE6E7L2
Naked pNGVL4aCRTE6E7L2 DNA plasmid
Experimental: pNGVL4aCRTE6E7L2 1 mg dose
Intermediate dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.
Biological: pNGVL4aCRTE6E7L2
Naked pNGVL4aCRTE6E7L2 DNA plasmid
Experimental: pNGVL4aCRTE6E7L2 3 mg dose
High dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.
Biological: pNGVL4aCRTE6E7L2
Naked pNGVL4aCRTE6E7L2 DNA plasmid
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.
Biological: pNGVL4aCRTE6E7L2
Naked pNGVL4aCRTE6E7L2 DNA plasmid
Biological: TA-CIN
TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination
Time Frame: 12 months
To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL
12 months
Dose finding
Time Frame: 12 months
To determine the appropriate intra-muscular injection dose of pNGVL4aCRTE6E7L2 DNA vaccine as determined by toxicity and immunogenicity for a subsequent phase II clinical trial
12 months
Safety and feasibility of PVX-6 vaccination
Time Frame: 12 months
To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine prime, TA-CIN protein vaccine boost in patients with persistent HPV16+ ASC-US/LSIL
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV16 antibody response
Time Frame: 12 months
To evaluate the levels of circulating antibody specific for HPV-16 in the peripheral blood pre- and post-vaccination
12 months
HPV16 CD8 T cell response
Time Frame: 12 months
To evaluate the levels of circulating HPV-16 E6- and E7-specific CD8+ T cells and T regulatory cells in the peripheral blood pre- and post-vaccination
12 months
HPV16 L2E7E6 T cell proliferative response
Time Frame: 12 months
To evaluate the proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2
12 months
Clearance of HPV16
Time Frame: 12 months
To evaluate the presence of high risk HPV, and specifically HPV16 in cytologic specimens pre- and post-vaccination
12 months
Cytologic clearance
Time Frame: 12 months
To evaluate changes in the cytopathology of ectocervical and endocervical specimens taken pre- and post-vaccination
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB IND 18340
  • 000540585 (Other Identifier: John's Hopkins University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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