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Virus Therapy
PVX-2 Vaccine for Atypical Squamous Cells (PVX2 Trial)
Phase 2
Waitlist Available
Led By Mark Einstein, MD, MS
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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
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)
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Who is running the clinical trial?
PapiVax Biotech, Inc.Lead Sponsor
4 Previous Clinical Trials
80 Total Patients Enrolled
ParexelIndustry Sponsor
306 Previous Clinical Trials
101,067 Total Patients Enrolled
Mark Einstein, MD, MSPrincipal InvestigatorProfessor and Chairman, Dept. of OBS&GYN, Rutgers New Jersey Medical School, Newark, NJ 07101
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had cancer in the last 5 years.You have a medical condition where your immune system attacks your own body (like rheumatoid arthritis or multiple sclerosis).
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: PVX-2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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