Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Human Papillomavirus, High-Grade Squamous Intraepithelial Lesions

In brief

The purpose of this research study is to test the safety and effectiveness of the investigational study vaccine, called TVGV-1. The study will test the vaccine in women with high grade HPV cervical infection.

Key facts

Study ID

NCT02576561

Run by

THEVAX Genetics Vaccine

People needed

10

Starts

2015-11-01

Expected to finish

2018-09-01

Last updated by the study team

2017-10-25

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female age 18 to 55 years
• Written informed consent in accordance with institutional guidelines
• Negative pregnancy test (urine and blood tests)
• Women of child bearing potential must agree to use contraception through one menstrual cycle post end of study or if early withdrawal, through what would have been visit 11. Methods include intrauterine device or double barrier method, hormonal contraceptive in combination with a double barrier method.
• Patients who have ONLY HPV 16 OR HPV 16 AND 18 and no other High-Risk HPV by Cobas test will be included.
• Histologically confirmed, positive HSIL of CIN2+ or higher (only CIN2+/3 subjects will be selected) cervical biopsy, confirmed by external (independent) pathologist panel within the 12 weeks prior to enrollment. If the standard care biopsy is not available for evaluation by the independent pathologist, a fresh biopsy and endocervical curettage will be required. The extent of colposcopic HSIL disease should not involve more than two quadrants of the cervix. Biopsies should be taken from each affected quadrant
• Adequate visualization of entire cervix, cervical lesion(s) and squamous-columnar junction
• Normal electrocardiogram (ECG), laboratory values (chemistry, complete blood count) and urinalysis, as judged Grade 0-1 by per National Cancer Institute Common Toxicity Criteria (NCI-CTC)
• Agrees to Loop Electrosurgical Excision Procedure (LEEP), Cold Knife Conization (CKC) or Hysterectomy being performed at the end of study according to the standard-of-care

You may not qualify if…

• History of cancer (excluding basal cell carcinoma of the skin) including cervical cancer
• Eastern Cooperative Oncology Group (ECOG) performance status >2 (See Appendix G)
• Administration of any blood product within 3 months of enrollment
• Active infection requiring antimicrobial treatment that would interfere with interpretation of adverse events, cutaneous reactions or efficacy. Treatment of minor concurrent infections should be limited to less than 10 days.
• Administration of any vaccine within 8 weeks of enrollment and within 4 weeks for flu vaccine.
• Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
• Any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, anticoagulants except platelet inhibitors (NSAIDs as needed for pain are permitted)
• Active drug or alcohol use or dependence that, in the opinion of the Site Investigator, would interfere with adherence to study protocol
• Skin conditions that require consistent use of topical corticosteroids or other local or systemic therapy that may interfere with interpretation or description of skin-related adverse events linked to vaccination
• The standard criteria for prospective clinical trials of medications developed by Drug-Induced Liver Injury Network (established by The National Institute of Diabetes and Digestive and Kidney Diseases) will be used to assess the laboratory test abnormalities. Normal range for these labs will typically be 5 - 40 IU/L for AST; 7 - 56 IU/L for ALT; 0.2 - 1.2 mg/dL for bilirubin. Subjects will be excluded if values are x 2-x 2.5 the upper limit
• Evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, dermatologic, immune disorder, or other disease that may interfere with assessment of safety or efficacy of vaccine activity as indicated in study objectives
• Any known allergic reaction to vaccine components
• Any other medical condition(s) that, in the judgment of the Site Investigator, might interfere with the study or require treatment that might interfere with the study
• Family member of the investigation study staff
• Pregnant or breast-feeding
• Inability to provide informed consent
• A subject with a history or expectation of noncompliance with medications or treatment protocol
• Receipt of (e.g. Gardasil® or Cervarix®) HPV preventative vaccines within 8 years of study enrollment
• Excessive use of acetaminophen or other potentially hepatotoxic drugs

Where it is running

• Visions Clinical Research - Tucson — Tucson, Arizona, United States
• Red Rocks OBGYN — Lakewood, Colorado, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• ProHEALTH Care Associates LLP — Port Jefferson, New York, United States
• Unified Women's Clinical Research — Raleigh, North Carolina, United States
• Unified Women's Clinical Research — Winston-Salem, North Carolina, United States
• Complete Healthcare for Women — Columbus, Ohio, United States
• Penn Fertility Care/Reproductive Research Unit Univ of Pennsylvania — Philadelphia, Pennsylvania, United States
• Insearch-Tidewater Clinical Research — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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