- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188850
Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100
August 8, 2018 updated by: Inovio Pharmaceuticals
Phase I, Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Previously Immunized With VGX-3100
DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages over traditional vaccines such as live attenuated virus and recombinant protein-based vaccines.
DNA vaccines appear to be well tolerated in humans.
Therefore, the investigators have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18.
The investigators have chosen to deliver our candidate vaccines via electroporation (EP) using the CELLECTRA constant current device to deliver a small electric charge following intramuscular (IM) injection, since animal studies have shown that this delivery method increases the immune response to our DNA vaccine leading to a decrease in the size of tumors caused by HPV 16 and 18.
In study HPV-001, the vaccine was given to subjects with a history of CIN 2 and 3 who had been previously treated by surgery.
This study is proposed to vaccinate the same subjects with a fourth dose of the VGX-3100 to determine the safety and immune response.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00909
- Clinical Research Puerto Rico
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Lyndhurst Gynecologic Associates
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Pennsylvania
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Hopwood, Pennsylvania, United States, 15904
- Laurel Highlands, OB/GYN, P.C.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Written informed consent in accordance with institutional guidelines;
- Successful enrollment in and completion of all study procedures and follow-up in study HPV-001.
- Female 18-46 years of age;
- Post surgical (including LEEP and conization) or ablative treatment and a diagnosis of CIN 2 or 3, while under physician care as per ASCCP guidelines (Appendix C);
- Normal ECG and CPK, as judged by Grade 0-1 as per Toxicity Grading Scale for Healthy Adults (Appendix B) done up to 30 days prior to administration of study treatment;
- Body mass index (BMI) ≤30 kg/m2;
- Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) from enrollment to study discharge;
- Able and willing to comply with all study procedures.
Exclusion Criteria:
- Active infection with herpes simplex virus (HSV);
- Pregnant or breast feeding subjects;
- Any concurrent condition requiring the continued use of systemic or topical steroids (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 1 of treatment;
- Administration of any blood product within 3 months of enrollment;
- Administration of any vaccine within 6 weeks of enrollment;
- Patient is currently participating or has participated in a study with an investigational compound or device other than VGX-3100 within 30 days of signing informed consent;
- Metal implants at the site of injection;
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
- Any other conditions judged by the investigator that would limit the evaluation of a subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 6mg of DNA/dose
Subjects who have previously received a 3 dose series of VGX-3100 containing either 0.6, 2 or 6mg DNA/dose will receive a fourth dose of VGX-3100 containing 6mg of DNA/dose administered via IM injection + electroporation at Day 0
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DNA plasmid delivered via IM injection + electroporation using CELLECTRA device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Safety and tolerability of a fourth dose of VGX-3100
Time Frame: through Month 6 (end of study)
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Safety and tolerability of a fourth dose of VGX-3100, administered by IM injection with EP to adult females who have been previously immunized with three doses of VGX-3100
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through Month 6 (end of study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Humoral and cellular immune responses to VGX-3100
Time Frame: through Month 6 (end of study)
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Humoral and cellular immune responses to VGX-3100 in blood samples obtained from study subjects after a fourth dose of VGX-3100 (6 mg) in adult female subjects who have been previously vaccinated with a three dose series of VGX-3100 containing 0.6, 2 or 6 mg of DNA/dose.
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through Month 6 (end of study)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Parker, MD, Lyndhurst Gynecologic Associates
- Principal Investigator: John Sunyecz, MD, Laurel Highlands, OB/GYN, P.C.
- Principal Investigator: Javier Morales, MD, Clinical Research Puerto Rico
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 20, 2011
Study Registration Dates
First Submitted
August 5, 2010
First Submitted That Met QC Criteria
August 25, 2010
First Posted (Estimate)
August 26, 2010
Study Record Updates
Last Update Posted (Actual)
August 10, 2018
Last Update Submitted That Met QC Criteria
August 8, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- HPV-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on VGX-3100
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Inovio PharmaceuticalsCompletedCervical Dysplasia | Cervical High Grade Squamous Intraepithelial Lesion | HSILUnited States, Spain, Portugal, Italy, Philippines, Thailand, Slovakia, Lithuania, Estonia, Belgium, South Africa, Germany, Argentina, United Kingdom, Poland, Puerto Rico, Finland, Mexico, Peru
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Inovio PharmaceuticalsCompletedCervical Dysplasia | Cervical High Grade Squamous Intraepithelial Lesion | HSILUnited States, Spain, Lithuania, Estonia, South Africa, Argentina, Brazil, Finland, Poland, Puerto Rico
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Inovio PharmaceuticalsUniversity of PennsylvaniaCompletedHead and Neck Squamous Cell CancerUnited States
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Inovio PharmaceuticalsCompletedCervical Intraepithelial NeoplasiaSouth Africa, United States, Korea, Republic of, Canada, Estonia, India, Georgia, Australia, Puerto Rico
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AIDS Malignancy ConsortiumNational Cancer Institute (NCI); The Emmes Company, LLC; Inovio PharmaceuticalsActive, not recruitingAnal Intraepithelial Neoplasia | High Grade Squamous Intraepithelial Neoplasia | HIV Positivity | Human Papillomavirus-16 Positive | Human Papillomavirus-18 PositiveUnited States, Puerto Rico
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Inovio PharmaceuticalsCompletedCervical CancerUnited States
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Inovio PharmaceuticalsCompletedHuman Papillomavirus (HPV) | Vulvar Dysplasia | Vulvar Intraepithelial Neoplasia (VIN) | Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) | VIN2 | VIN3 | Pre-cancerous Lesions of the VulvaUnited States
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VGX Pharmaceuticals, LLCGeneOne Life Science, Inc.Completed