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Virus Therapy

PVX-2 Vaccine for Atypical Squamous Cells (PVX-2 Trial)

Phase 2
Waitlist Available
Research Sponsored by PapiVax Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PVX-2 Trial Summary

This trial is testing a new immunization regimen for HPV which consists of two shots of a DNA vaccine and one shot of a TA-CIN vaccine. The goal is to see if this regimen is safe and effective at clearing HPV 16 by Month 6.

Who is the study for?
This trial is for women aged 25-70 with HPV16+ abnormal cervical cells but not worse than CIN2. They must be HIV negative, have a BMI ≤ 32 kg/m^2, and no hepatitis C. Participants should agree to use contraception or abstain from sex for six months and have good organ function. Exclusions include a cancer history within five years, pregnancy attempts soon, immunodeficiency conditions, recent receipt of blood products or vaccines, major surgeries or treatments.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of two injections: pNGVL4a Sig/E7(detox)/HSP70 DNA and TA-CIN against HPV16 by month six. One group receives PVX-2 (the actual treatment), while another gets a placebo to compare results.See study design
What are the potential side effects?
Possible side effects may include typical reactions at the injection site like pain or swelling, flu-like symptoms such as fever or tiredness, allergic responses to components in the vaccine regimen could occur but are less common.

PVX-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
Percent of patients that have cleared HPV16 at Month 6
Secondary outcome measures
Percent of patients that have cleared HPV16 at Month 12
Percent of patients that have normal cytology at Month 6

PVX-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PVX-2Experimental Treatment1 Intervention
Prime: 3 mg pNGVL4a-Sig/E7(detox)/HSP70 DNA Boost: 0.1 mg TA-CIN protein
Group II: PlaceboPlacebo Group1 Intervention
Prime: PBS (Phosphate Buffered Saline) Boost: PGC (Phosphate Glycine Cysteine Buffer)

Find a Location

Who is running the clinical trial?

PapiVax Biotech, Inc.Lead Sponsor
4 Previous Clinical Trials
80 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,692 Total Patients Enrolled

Media Library

pNGVL4a-Sig/E7(detox)/HSP70 DNA (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03911076 — Phase 2
Atypical Squamous Cells Research Study Groups: Placebo, PVX-2
Atypical Squamous Cells Clinical Trial 2023: pNGVL4a-Sig/E7(detox)/HSP70 DNA Highlights & Side Effects. Trial Name: NCT03911076 — Phase 2
pNGVL4a-Sig/E7(detox)/HSP70 DNA (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03911076 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the required medical condition able to participate in this trial right now?

"That is accurate. The clinical trial in question, which was originally posted on May 22nd, 2019, is still seeking participants. 7 different locations are involved in the recruitment process with a goal of 134 patients total."

Answered by AI

Do many hospitals in America offer this type of treatment?

"Right now, there are 7 different sites where this trial is enrolling patients They can be found in Irving, Newark and Austin as well other locations. If you're interested in enrolling, try to choose the site that is closest to your residence to cut down on travel time."

Answered by AI

Has the PVX-2 antiviral medication been cleared by the FDA?

"There is limited data on the safety of PVX-2, as this is only a Phase 2 trial. This means that while there are no reports supporting efficacy, there are some positive indicators for safety."

Answered by AI

How many study participants are there in total?

"134 patients that meet the clinical trial's inclusion criteria are required in order for the study to have enough statistical power. The sponsor, Parexel, will be running the trial from different sites including MacArthur Medical Center in Irving, New jersey and University Hospital, Rutgers New Jersey Medical School in Newark, Florida."

Answered by AI

For which patients is this research project seeking new participants?

"134 patients with squamous intraepithelial lesions of the cervix, aged 25 to 70, are being enrolled in this clinical trial. Most notably, applicants should meet the following criteria: female subjects who are age 25-70 years old and have confirmation of ASC-US, ASC-H, or LSIL by liquid-based cytology; HIV uninfected; Patients whose cytologic specimen is HPV16+ by Aptima HPV 16 18/45 Genotype Assay; Body Mass Index ≤ 32 kg/m2; Hepatitis b surface antigen negative; Anti-hepatitis c virus antibody (anti-HC"

Answered by AI

Does this research study have an age limit?

"According to the eligibility requirements set out by the research team, patients must be aged between 25 and 70 to take part in this trial. There is 1 other study available for individuals under 18 years old and 17 studies designed for seniors above the age of 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL
2019. "Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911076.
~23 spots leftby Apr 2025
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