Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL
NCT ID: NCT02576561
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2015-11-30
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The objective of the TVGV-1 program is to develop a non-surgical alternative that is reliable, safe, and would avoid potential surgical risks such as preterm birth, perinatal mortality, risk of infertility, incontinence and disfigurement, as well as reduced cost and inconvenience for an otherwise economically productive young subject population.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TVGV-1 (cohort 1)
Antigen + Adjuvant - 0.6 mg lyophilized PEK fusion protein + 0.6 ml\* GPI- 0100 (1:1 ratio)
TVGV-1
Antigen + Adjuvant
GPI-0100 (cohort 1)
Adjuvant Alone - 0 mg lyophilized PEK fusion protein. 0.6 mg lyophilized placebo cake + 0.6 ml\* GPI- 0100 (1:1 ratio)
GPI-0100
Adjuvant Alone
Placebo (cohort 1)
Placebo- 0 mg lyophilized PEK fusion protein. 0.6 mg lyophilized placebo cake + 0.6 ml placebo-diluent (1:1 ratio)
Placebo
Placebo
TVGV-1 (cohort 2)
Antigen + Adjuvant - 0.9 mg lyophilized PEK fusion protein + 0.9 ml\* GPI- 0100 (1:1 ratio)
TVGV-1
Antigen + Adjuvant
GPI-0100 (cohort 2)
Adjuvant Alone - 0 mg lyophilized PEK fusion protein. 0.9 mg lyophilized placebo cake + 0.9 ml\* GPI- 0100 (1:1 ratio)
GPI-0100
Adjuvant Alone
Placebo (cohort 2)
Placebo - 0 mg lyophilized PEK fusion protein. 0.9 mg lyophilized placebo cake + 0.9 ml placebo diluent (1:1 ratio)
Placebo
Placebo
TVGV-1 (cohort 3)
Antigen + Adjuvant - 1.2 mg lyophilized PEK fusion protein + 1.2 ml\* GPI- 0100 (1:1 ratio)
TVGV-1
Antigen + Adjuvant
GPI-0100 (cohort 3)
Adjuvant Alone - 0 mg lyophilized PEK fusion protein + 1.2 mg lyophilized placebo cake 1.2 ml\* GPI- 0100 (1:1 ratio)
GPI-0100
Adjuvant Alone
Placebo (cohort 3)
Placebo - 0 mg lyophilized PEK fusion protein. 1.2 mg lyophilized placebo cake + 1.2 ml placebo-diluent (1:1 ratio)
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TVGV-1
Antigen + Adjuvant
GPI-0100
Adjuvant Alone
Placebo
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Written informed consent in accordance with institutional guidelines
3. Negative pregnancy test (urine and blood tests)
4. 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.
5. Patients who have ONLY HPV 16 OR HPV 16 AND 18 and no other High-Risk HPV by Cobas test will be included.
6. 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
7. Adequate visualization of entire cervix, cervical lesion(s) and squamous-columnar junction
8. 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)
9. 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
Exclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status \>2 (See Appendix G)
3. Administration of any blood product within 3 months of enrollment
4. 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.
5. Administration of any vaccine within 8 weeks of enrollment and within 4 weeks for flu vaccine.
6. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
7. 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)
8. Active drug or alcohol use or dependence that, in the opinion of the Site Investigator, would interfere with adherence to study protocol
9. 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
10. 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
11. 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
12. Any known allergic reaction to vaccine components
13. 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
14. Family member of the investigation study staff
15. Pregnant or breast-feeding
16. Inability to provide informed consent
17. A subject with a history or expectation of noncompliance with medications or treatment protocol
18. Receipt of (e.g. Gardasil® or Cervarix®) HPV preventative vaccines within 8 years of study enrollment
19. Excessive use of acetaminophen or other potentially hepatotoxic drugs
18 Years
55 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinical Research Management, Inc.
INDUSTRY
THEVAX Genetics Vaccine
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frank L Douglas, PhD, MD
Role: STUDY_DIRECTOR
THEVAX Genetics Vaccine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VAX 02-01
Identifier Type: -
Identifier Source: org_study_id