Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL (NCT02576561) | Clinical Trial Compass
UnknownPhase 2
Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL
United States10 participantsStarted 2015-11
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
Exclusion criteria
✕. History of cancer (excluding basal cell carcinoma of the skin) including cervical cancer
What they're measuring
1
Absence of histologic HSIL (CIN2/3) as assessed by biopsy at last study Visit 11, Day 270.
Timeframe: DAY 270
2
Assessment of cutaneous toxicities (i.e., size, induration and time to resolution of skin reactions to vaccine).
. 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