Treatment for HPV16 positive cervical abnormalities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I clinical trial evaluates the safety and feasibility of a DNA vaccine (pNGVL4aCRTE6E7L2) and a protein vaccine (TA-CIN) for patients with persistent HPV16 positive ASC-US or LSIL. The study aims to determine the appropriate dosage of the DNA vaccine through intra-muscular administration and assess its immunogenicity and toxicity. Participants will receive the DNA vaccine followed by a boost with the TA-CIN protein vaccine to enhance immune response against HPV16.

Why it matters

Who can join: the full rules

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.

Where it's running

• UAB | The University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Wendy Wu, MS
• Email: wendy@papivax.com.tw
• Phone: +886 2 8226 8451

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dysplasix™ intravaginal suppositories for women with high‑risk HPV and mild cervical cell changes

  This trial tests whether nightly Dysplasix™ vaginal suppositories can clear high‑risk HPV and help mild cervical cell changes (ASC‑US or LSIL) in adult women.

  Recruiting Phase 2 Amplexd Therapeutics, Inc. · Shatin, New Territories · NCT07572396

• ALA-PDT for cervical LSIL with HPV16/18 in multiple centers

  This study tests whether aminolevulinic acid–mediated photodynamic therapy can treat cervical LSIL in people with HPV16/18 compared with just observation.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang and 4 other locations · NCT07306247

• Pap smear versus a three-marker blood test to find cervical precancer and cancer

  This tests whether a blood test that measures three molecular markers can find cervical precursor lesions and cancer as well as the Pap smear in women 18 to 85.

  Recruiting Timser SAPI de CV · Mexico City, Mexico City · NCT07480902

• Anal cancer screening for men on PrEP

  This study will test how well anal swabs and DNA methylation testing find high-grade anal lesions (HSIL) and how common those lesions are in men who have sex with men using PrEP, and whether HSIL affects quality of life.

  Recruiting at 6 sites Universitair Ziekenhuis Brussel · Bruges and 7 other locations · NCT07029152

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.