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UNKNOWNPHASE2

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

Phase 2a Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of Three Doses of TVGV-1 Vaccine Compared to Its Adjuvant, GPI-0100, in Subjects With Histologically Confirmed HPV Induced Cervical HSIL

NCT02576561•THEVAX Genetics Vaccine

View on ClinicalTrials.gov

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.

Detailed Description

The purpose of the Phase 2a Study VAX 02-01 is to assess the safety and activity of TVGV-1 vaccine construct in achieving the absence of histologic HSIL (CIN2/3) (regression to LSIL or less) as assessed by biopsy at last study Visit 11, Day 270. 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.

Eligibility

Age

18 - 55 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female age 18 to 55 years
•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

•1. History of cancer (excluding basal cell carcinoma of the skin) including cervical cancer
•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
+9 more criteria

Locations (11)

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

Key Dates

Start Date

November 1, 2015

Primary Completion Date

May 1, 2018

Completion Date

September 1, 2018

Last Updated

October 25, 2017

Enrollment

ACTUAL participants

Conditions

Human PapillomavirusHigh-Grade Squamous Intraepithelial Lesions

Interventions

TVGV-1

BIOLOGICAL

GPI-0100

BIOLOGICAL

Placebo

BIOLOGICAL

Stories to Prevent (StoP) HPV Cancers

NCT06808776

Human Papillomavirus VaccinationEmotions

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RECRUITING

Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma, PAP-OP Study

NCT06115772

Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Stories to Prevent (StoP) HPV Cancers

Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma, PAP-OP Study

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