A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix

CompletadoFase 3ClinicalTrials.gov

ID: NCT03185013RENIS: IS002166Tipo: INTERVENTIONALInicio: 28 de jun de 2017Fin estimado: 6 de abr de 2021

Gastroenterología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Women aged 18 years and above
Confirmed cervical infection with HPV types 16 and/or 18 at screening
Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
Confirmed histologic evidence of cervical HSIL at screening
Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
Normal screening electrocardiogram (ECG)

Criterios de exclusión

Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
Cervical lesion(s) that cannot be fully visualized on colposcopy
History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
Treatment for cervical HSIL within 4 weeks prior to screening
Pregnant, breastfeeding or considering becoming pregnant during the study
History of previous therapeutic HPV vaccination
Immunosuppression as a result of underlying illness or treatment
Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
Receipt of any non-study, live vaccine within 4 weeks of Day 0
Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
Less than two acceptable sites available for IM injection

Intervenciones

biological

VGX-3100

1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

biological

Placebo

1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

device

Electroporation (EP)

Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.

Ubicaciones

Instituto de Ginecología

Rosario, Santa Fe Province, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

DIM Clínica Privada

Ramos Mejía, Argentina

Patrocinadores

PrincipalInovio Pharmaceuticals

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