NCT03913117

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
16mo left

Started Jul 2023

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jul 2023Sep 2027

First Submitted

Initial submission to the registry

April 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
4.2 years until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

3.8 years

First QC Date

April 10, 2019

Last Update Submit

June 25, 2025

Conditions

ASC-USLSIL

Keywords

HPV16

Outcome Measures

Primary Outcomes (3)

  • Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination

    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

    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

    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 Outcomes (5)

  • HPV16 antibody response

    12 months

  • HPV16 CD8 T cell response

    12 months

  • HPV16 L2E7E6 T cell proliferative response

    12 months

  • Clearance of HPV16

    12 months

  • Cytologic clearance

    12 months

Study Arms (4)

pNGVL4aCRTE6E7L2 0.3mg dose

EXPERIMENTAL

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

Biological: pNGVL4aCRTE6E7L2

pNGVL4aCRTE6E7L2 1 mg dose

EXPERIMENTAL

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

Biological: pNGVL4aCRTE6E7L2

pNGVL4aCRTE6E7L2 3 mg dose

EXPERIMENTAL

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

Biological: pNGVL4aCRTE6E7L2

PVX-6

EXPERIMENTAL

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: pNGVL4aCRTE6E7L2Biological: TA-CIN

Interventions

pNGVL4aCRTE6E7L2BIOLOGICAL

Naked pNGVL4aCRTE6E7L2 DNA plasmid

PVX-6pNGVL4aCRTE6E7L2 0.3mg dosepNGVL4aCRTE6E7L2 1 mg dosepNGVL4aCRTE6E7L2 3 mg dose
TA-CINBIOLOGICAL

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

PVX-6

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients with a cervical cytologic diagnosis of ASC-US or LSIL
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with persistent (\>6 month period) ASC-US/LSIL determined by cervical cytology at study entry (ThinPrep with imaging)
  • 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.
  • Age ≥ 19 years
  • Baseline Eastern Cooperative Oncology Group
  • 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
  • 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.
  • Ability to understand and the willingness to sign a written informed consent document.
  • +1 more criteria

You may not qualify if:

  • Patients with ASC-US/LSIL determined by cervical cytology at study entry that are HPV16 negative.
  • Histologic evidence of CIN2+
  • Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids.
  • Prior vaccination with any HPV antigen (prophylactic or therapeutic).
  • Patients who are receiving any other investigational agents within 28 days prior to the first dose.
  • 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.
  • Patients with a history of autoimmune disease such as multiple sclerosis, exclusive of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.
  • Patients with a history of allergic reactions attributed to compounds used in agent preparation.
  • Patients who are pregnant or breast feeding.
  • Patient with active or chronic infection of HIV, HCV, or HBV.
  • Patients who have had a prior LEEP or cervical conization procedure.
  • 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.
  • Inability to understand or unwillingness to sign an informed consent document.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UAB | The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21231, United States

RECRUITING

MeSH Terms

Conditions

Atypical Squamous Cells of the Cervix

Condition Hierarchy (Ancestors)

Uterine Cervical DysplasiaPrecancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Central Study Contacts

Wendy Wu, MS

CONTACT

+886 2 8226 8451wendy@papivax.com.tw

Yung-Nien Chang, Ph.D.

CONTACT

410-804-9662changyn@papivax.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose escalation study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Division Director Gynecology Oncology

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 12, 2019

Study Start

July 10, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 26, 2025

Record last verified: 2025-06

Locations

US(2)