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Cancer Vaccine
HPV DNA Vaccine for HPV-Related Cervical Disease
Phase 1
Recruiting
Led By Kimberly Levinson, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of childbearing potential are defined as any female who has experienced menarche and does not meet the criteria for "women not of childbearing potential" defined below.
Age ≥19 years. Also due to Alabama law the age a person is no longer a minor needing parental consent is 19, so all participants need to be 19 or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
Study Summary
This trial is testing a new vaccine to see if it is safe and effective in preventing HPV in women.
Who is the study for?
This trial is for adult women (19+ years) with high-grade cervical lesions (CIN2/3) that are HPV16 positive. It includes both HIV-negative and HIV-positive participants who have controlled their condition, with specific blood count levels and normal organ function. Pregnant or breastfeeding women, those allergic to similar vaccines, or with certain health conditions are excluded.Check my eligibility
What is being tested?
The study tests the safety and tolerability of a new HPV DNA vaccine called pNGVL4aCRTE6E7L2 delivered by injection with electroporation in women diagnosed with CIN II or III caused by HPV16. The trial will include both HIV-negative and HIV-positive subjects.See study design
What are the potential side effects?
Potential side effects aren't detailed but may include typical vaccine reactions such as pain at the injection site, swelling, redness, fever, fatigue, muscle aches. Since it's an investigational vaccine, there may be unknown risks which will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman capable of becoming pregnant.
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I am 19 years old or older.
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I have been diagnosed with HIV-1.
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I am a woman who has undergone permanent sterilization.
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I have high-grade cervical lesions and am HIV negative.
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I can perform all my usual activities without assistance.
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I am HIV positive with a confirmed high-grade cervical lesion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants experiencing dose limiting toxicities at each dosing level
Trial Design
3Treatment groups
Experimental Treatment
Group I: Vaccination Arm Level 3Experimental Treatment1 Intervention
The dose escalation of pNGVL4aCRTE6E7L2 will be conducted to evaluate the safety of three escalating doses; level 3 dose of 3.0 mg
Group II: Vaccination Arm Level 2Experimental Treatment1 Intervention
The dose escalation of pNGVL4aCRTE6E7L2 will be conducted to evaluate the safety of three escalating doses; level 2 at dose 1.0 mg
Group III: Vaccination Arm Level 1Experimental Treatment1 Intervention
The dose escalation of pNGVL4aCRTE6E7L2 will be conducted to evaluate the safety of three escalating doses; Level 1 dose of 0.3 mg
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,872 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,806 Total Patients Enrolled
Kimberly Levinson, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman capable of becoming pregnant.I do not have any ongoing or chronic neurological conditions, except for a one-time fever-related seizure in childhood.My cervical condition is severe but not caused by HPV16.I use condoms for contraception.I use a diaphragm, cervical cap, or sponge with spermicide for birth control.I am 19 years old or older.I am not pregnant or breastfeeding.I do not have any ongoing serious illnesses that could interfere with the study.I have been diagnosed with HIV-1.I have an autoimmune disease like lupus, celiac, or MS, but not thyroiditis, psoriasis, Sjogren's, or IBD.You need to use two forms of birth control, like condoms and another method, to prevent pregnancy.My organ and bone marrow functions are normal.I do not have active hepatitis C or B, and I have never received an HPV vaccine.I am able and willing to understand and sign the consent form.I have fainted in the last year.I am a woman who has undergone permanent sterilization.I have high-grade cervical lesions and am HIV negative.I have no significant heart, lung, liver, kidney, or blood disorders as checked by my doctor.You have had allergic reactions to substances similar to the DNA vaccine being tested.I can perform all my usual activities without assistance.I am HIV positive with a confirmed high-grade cervical lesion.I haven't had cancer in the last 5 years, except for completely removed skin cancer.My HIV-1 levels are below 200 copies/mL, confirmed by two tests.My cervical sample tested positive for HPV16.I haven't taken long-term immune system drugs or high-dose steroids in the last 6 months.I haven't received immunoglobulins or blood products in the last 120 days and don't plan to during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vaccination Arm Level 2
- Group 2: Vaccination Arm Level 3
- Group 3: Vaccination Arm Level 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Human Papillomavirus Patient Testimony for trial: Trial Name: NCT04131413 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant count for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this trial began accepting patients on September 14th 2020 and is still recruiting as of April 13th 2022. 48 individuals are being recruited from two sites for this study."
Answered by AI
Are researchers accepting new participants for this study at the present time?
"Affirmative. According to clinicaltrials.gov, the research was publicised on September 14th 2020 and most recently updated on April 13th 2022. The trial requires 48 participants between 2 sites for enrollment into the study."
Answered by AI
Has this treatment been validated by the FDA?
"This treatment has a safety rating of 1 due to its Phase 1 status, indicating that the efficacy and safety have yet to be established."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Alabama
What site did they apply to?
Johns Hopkins University
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I love to help others. I don't really know what to do I just need help and this is all really confusing.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Johns Hopkins University: < 48 hours
Average response time
- < 2 Days
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