RecruitingPhase 1

Study of Treatment for HPV16+ ASC-US or LSIL

United States30 participantsStarted 2023-07-10

Plain-language 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

Who can participate

Age range19 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination

Timeframe: 12 months

Dose finding

Timeframe: 12 months

Safety and feasibility of PVX-6 vaccination

Timeframe: 12 months

Trial details

NCT IDNCT03913117

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Wendy Wu, MS

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

View on ClinicalTrials.gov More ASC-US trials

Who can participate

Age range19 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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.