ASC-USPhase 1PVX-6NCT03913117
Study of Treatment for HPV16+ ASC-US or LSIL
A Phase 1 study testing pNGVL4aCRTE6E7L2 and TA-CIN in people with ASC-US and LSIL, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- What is being tested?
- pNGVL4aCRTE6E7L2 and TA-CIN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2023to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Subject is able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21231
Kimberly Levinson, M.D., klevins1@jhmi.edu
Richard Roden, 410=502-5161, roden@jhmi.edu
- Recruiting
UAB | The University of Alabama at Birmingham
Birmingham, Alabama, 35249
Meg Thomas, margaretannthomas@uabmc.edu
About this study
Official title: 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
Read the detailed description
Primary Objectives
- To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL.
- 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.
- 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.
- Being tested
- pNGVL4aCRTE6E7L2, TA-CIN
- Keywords
- HPV16
- Medical subject headings
- Atypical Squamous Cells of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pNGVL4aCRTE6E7L2Biological
Naked pNGVL4aCRTE6E7L2 DNA plasmid
TA-CINBiological
TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.
| Study group | Role | What they receive |
|---|---|---|
| pNGVL4aCRTE6E7L2 0.3mg dose | Experimental | Low dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8. Receives: Biological: pNGVL4aCRTE6E7L2 |
| pNGVL4aCRTE6E7L2 1 mg dose | Experimental | Intermediate dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8. Receives: Biological: pNGVL4aCRTE6E7L2 |
| pNGVL4aCRTE6E7L2 3 mg dose | Experimental | High dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8. Receives: 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. Receives: Biological: pNGVL4aCRTE6E7L2; Biological: TA-CIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (5)
HPV16 antibody response
To evaluate the levels of circulating antibody specific for HPV-16 in the peripheral blood pre- and post-vaccination
Measured: 12 months
HPV16 CD8 T cell response
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
Measured: 12 months
HPV16 L2E7E6 T cell proliferative response
To evaluate the proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2
Measured: 12 months
Clearance of HPV16
To evaluate the presence of high risk HPV, and specifically HPV16 in cytologic specimens pre- and post-vaccination
Measured: 12 months
Cytologic clearance
To evaluate changes in the cytopathology of ectocervical and endocervical specimens taken pre- and post-vaccination
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start10 Jul 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASC-USStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Rebecca Arend, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913117
- Sponsor's protocol ID
- BB IND 18340
- Other IDs
- 000540585
- Acronym
- PVX-6
- Status last verified
- May 2026
- First submitted
- 10 Apr 2019
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03913117
- Acronym / sponsor ID
- PVX-6 / BB IND 18340
- Keywords
- HPV16
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary Objectives
- To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| pNGVL4aCRTE6E7L2 0.3mg dose | Experimental | Biological: pNGVL4aCRTE6E7L2Low dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8. |
| pNGVL4aCRTE6E7L2 1 mg dose | Experimental | Biological: pNGVL4aCRTE6E7L2Intermediate dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8. |
| pNGVL4aCRTE6E7L2 3 mg dose | Experimental | Biological: pNGVL4aCRTE6E7L2High dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8. |
| PVX-6 | Experimental | Biological: pNGVL4aCRTE6E7L2, Biological: TA-CINSelected 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pNGVL4aCRTE6E7L2Naked pNGVL4aCRTE6E7L2 DNA plasmid | Biological | PVX-6, pNGVL4aCRTE6E7L2 0.3mg dose, pNGVL4aCRTE6E7L2 1 mg dose, pNGVL4aCRTE6E7L2 3 mg dose |
| TA-CINTA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem. | Biological | PVX-6 |
Primary outcome
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
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
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
5 secondary outcomes
HPV16 antibody response
Time frame: 12 months
HPV16 CD8 T cell response
Time frame: 12 months
HPV16 L2E7E6 T cell proliferative response
Time frame: 12 months
Clearance of HPV16
Time frame: 12 months
Cytologic clearance
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pNGVL4aCRTE6E7L2 and TA-CIN in people with ASC-US and LSIL, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Wu, MS (+886 2 8226 8451, wendy@papivax.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.