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Cancer Vaccine

HPV Vaccine for Cervical Cell Changes (PVX-6 Trial)

Phase 1

Recruiting

Research Sponsored by PapiVax Biotech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 19 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

PVX-6 Trial Summary

This trial is testing if a new vaccine is safe, and if it is, what the right dose is.

Who is the study for?

This trial is for individuals over 19 years old with persistent HPV16+ ASC-US/LSIL cervical lesions. They must have good organ function, agree to use two forms of contraception, and be able to follow the study schedule. Excluded are those with more advanced cervical changes, immunosuppression, other serious health issues, pregnancy or breastfeeding, certain infections (HIV/HCV/HBV), prior malignancy within 5 years (except some skin cancers), previous LEEP/conization procedures or HPV vaccinations.Check my eligibility

What is being tested?

The trial is testing the safety and proper dosage of pNGVL4aCRTE6E7L2 DNA vaccine and TA-CIN protein vaccination in patients with specific types of precancerous cervical lesions caused by HPV16. It's a Phase I study which means it's early in the clinical trials process focusing on safety.See study design

What are the potential side effects?

As this is a Phase I trial primarily assessing safety and dosage levels, potential side effects may not be fully known yet but could include typical vaccine-related reactions such as pain at injection site, fever, fatigue or allergic responses.

PVX-6 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 19 years old or older.

PVX-6 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Dose finding

Safety and feasibility of PVX-6 vaccination

Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination

Secondary outcome measures

Clearance of HPV16

Cytologic clearance

HPV16 CD8 T cell response

+2 more

PVX-6 Trial Design

4Treatment groups

Experimental Treatment

Group I: pNGVL4aCRTE6E7L2 3 mg doseExperimental Treatment1 Intervention

High dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

Group II: pNGVL4aCRTE6E7L2 1 mg doseExperimental Treatment1 Intervention

Intermediate dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

Group III: pNGVL4aCRTE6E7L2 0.3mg doseExperimental Treatment1 Intervention

Low dose of pNGVL4aCRTE6E7L2 plasmid DNA is administered by intramuscular injection at weeks 0, 4 and 8.

Group IV: PVX-6Experimental Treatment2 Interventions

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

PapiVax Biotech, Inc.Lead Sponsor

4 Previous Clinical Trials

184 Total Patients Enrolled

University of Alabama at BirminghamLead Sponsor

1,584 Previous Clinical Trials

2,280,044 Total Patients Enrolled

Johns Hopkins UniversityOTHER

2,260 Previous Clinical Trials

14,820,750 Total Patients Enrolled

Media Library

pNGVL4aCRTE6E7L2 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03913117 — Phase 1

Squamous Intraepithelial Lesion Research Study Groups: PVX-6, pNGVL4aCRTE6E7L2 0.3mg dose, pNGVL4aCRTE6E7L2 1 mg dose, pNGVL4aCRTE6E7L2 3 mg dose

Squamous Intraepithelial Lesion Clinical Trial 2023: pNGVL4aCRTE6E7L2 Highlights & Side Effects. Trial Name: NCT03913117 — Phase 1

pNGVL4aCRTE6E7L2 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03913117 — Phase 1

Frequently Asked Questions

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

Is this research project in progress and currently welcoming participants?

"Unfortunately, this clinical trial is not open for recruitment at the moment. It was initially published on December 31st 2022 and last edited April 18th 2022. However, if you are looking alternative studies to participate in, there are currently two trials involving lsil and two trials with pNGVL4aCRTE6E7L2 still enrolling participants."

Answered by AI

Does the FDA recognize pNGVL4aCRTE6E7L2 as a legitimate drug?

"The safety of pNGVL4aCRTE6E7L2 is rated at a 1, given that the current Phase 1 trial has little evidence to suggest its efficacy and limited data on patient safety."

Answered by AI

What preceding investigations have been conducted regarding pNGVL4aCRTE6E7L2?

"At the moment, two trials are underway that explore pNGVL4aCRTE6E7L2. None of these experiences have entered Phase 3 as yet. Birmingham, Alabama is hosting most of these studies; however there are three other sites conducting research regarding this treatment."

Answered by AI

How many participants are recruited for this clinical experiment?

"This trial is no longer recruiting patients; it was initially posted on December 31st 2022 and the last update occurred on April 18th 2022. However, if you are seeking alternative studies, there are currently two trials for lsil and two studies involving pNGVL4aCRTE6E7L2 that need participants."

Answered by AI

What is the ultimate objective of this research endeavor?

"The primary aim of this year-long trial is to ascertain the optimal dosage. Researchers are also assessing antibodies, CD8 T cells, and mononucleocyte proliferation in response to HPV16 E6, E7 and L2 stimulation as secondary outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Treatment for HPV16+ ASC-US or LSIL

Rebecca Arend 2023. "Study of Treatment for HPV16+ ASC-US or LSIL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913117.

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