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Sponsored by: |
VGX Pharmaceuticals, Inc. |
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Information provided by: | VGX Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00685412 |
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, we have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18. We 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. The vaccine is proposed to be given to patients with a history of CIN 2 and 3 that have been treated by surgery. We will determine which dose the DNA vaccine will be the best tolerated and elicit the strongest immune response.
Condition | Intervention | Phase |
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Papillomavirus Infections |
Biological: VGX-3100 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Post Surgical or Ablative Treatment of Grade 2 or 3 Cervical Intraepithelial Neoplasia (CIN) |
Estimated Enrollment: | 24 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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0.6mg: Experimental
0.6mg DNA/dose
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Biological: VGX-3100
DNA plasmid delivered via electroporation using CELLECTRA device
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2mg: Experimental
2mg DNA/dose
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Biological: VGX-3100
DNA plasmid delivered via electroporation using CELLECTRA device
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6mg: Experimental
6mg DNA/dose
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Biological: VGX-3100
DNA plasmid delivered via electroporation using CELLECTRA device
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Study Director, MS | 267-440-4231 |
United States, North Carolina | |
Lyndhurst Gynecologic Associates | Recruiting |
Winston-Salem, North Carolina, United States, 27103 | |
Contact: Tracy Crawford 336-765-7537 | |
Principal Investigator: Robert L Parker, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Tina Lowther, MD 215-573-3413 | |
Principal Investigator: Christina Chu, MD |
Principal Investigator: | Christina Chu, MD | University of Pennsylvania |
Principal Investigator: | Robert Parker, MD | Lyndhurst Gynecologic Associates |
Responsible Party: | VGX Pharmaceuticals, Inc ( Chief Medical Officer ) |
Study ID Numbers: | HPV001 |
Study First Received: | May 22, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00685412 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CIN 2 or 3 cervical cancer |
Virus Diseases Carcinoma in Situ DNA Virus Infections Papillomavirus Infections |
Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Virus Diseases Neoplasms Neoplasms by Histologic Type Carcinoma in Situ Tumor Virus Infections DNA Virus Infections |
Papillomavirus Infections Infection Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |