- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00091130
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
An Exploratory Study to Evaluate the Effect of HPV 16 Vaccine on the Reduction of Viral Load in HPV 16 Positive Women With Persistent Viral Infection, But Low Grade Disease (ASCUS/LSIL)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. Compare the effectiveness of SGN-00101 vaccine vs placebo in reducing the human papillomavirus (HPV)-16 viral load in patients with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) of the cervix with persistent HPV-16 infection who are at increased risk for developing a high-grade squamous intraepithelial lesion or invasive cervical cancer.
II. Compare the natural history of HPV-16 viral load in patients treated with these regimens.
III. Compare the effect of HPV-16 variants on viral load response in patients treated with these regimens.
IV. Compare the relative effectiveness of these regimens on the regression of cervical cellular atypias (based on Pap test results), in terms of the regression of cytologic findings of LSIL and ASCUS to normal findings and resolution or regression of colposcopically defined cervicovaginal lesions, in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive SGN-00101 vaccine subcutaneously (SC) on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
ARM II: Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
Patients are followed at 12, 24, and 52 weeks after the last vaccination.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Orange, California, Estados Unidos, 92868
- University of California Medical Center At Irvine-Orange Campus
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Meets criteria for 1 of the following groups:
Prospective group, meeting the following criteria:
- Evidence of atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) by Pap test
- Human papillomavirus (HPV)-16-positive by polymerase chain reaction (PCR) and PGMY09/PGMY11 oligonucleotide primers viral load assay
Medical records-based group, meeting the following criteria:
- Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months
Meets 1 of the following criteria:
- Liquid-cytology findings of ASCUS or LSIL
- Colposcopic evidence of a LSIL by the Reid Index score of 1-5
- Historically persistent HPV-16-infection by PCR and HPV reverse transcription (RT)-PCR
- No evidence of high-grade squamous intraepithelial lesions (HSIL) by colposcopy (Reid Index ≥ 6)
- Reports no sex partner change since last index Pap screening test
Specimen-based group, meeting the following criteria:
Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months
- Liquid-based cytology specimen available
Meets 1 of the following criteria:
- Liquid-cytology findings of ASCUS or LSIL
- Colposcopic evidence of a LSIL by the Reid Index score of 1-5
- Historically persistent HPV-16-infection by PCR and, where measurable, HPV RT-PCR showing no greater than 3-fold reduction over the index liquid-cytology specimen
- No evidence of HSIL by colposcopy (Reid Index ≥ 6)
- Menstrual period occurred at least once within the past 52 weeks
- No HSIL by Pap test within the past year
- Performance status - ECOG 0
- No severe or unstable coagulation
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- No angina
- No heart failure
- No other cardiac condition
- No respiratory condition
- No asthma
- No immunological disorders (e.g., lupus, diabetes, multiple sclerosis, or myasthenia gravis)
- Not immunocompromised, suggestive of severe immune deficiency
- HIV negative
- No AIDS
- No active infection, defined as fever > 100° F
- No syphilis
- No severe allergic reactions (anaphylactic response) to drugs or any other allergen
- No history of allergy to any vaccine constituents, including cell- or tissue-system elements used to prepare the vaccine (e.g., bread products, yeast, or recombinant DNA technology using yeast systems)
- Must agree to use effective form of contraception throughout vaccination period
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during vaccination period and for 5 months after study treatment
- No sexual intercourse within 48 hours of virus specimen collection during study visits
- No objects (e.g., tampons, douche, suppositories, fingers, or toes) within the vagina or rectum within 48 hours of virus specimen collection during study visits
- No prior malignancy except nonmelanoma skin cancer
- No medical or psychiatric illness than would preclude study participation or compliance
- No other disorders requiring medical intervention that would preclude study participation
- No prior HPV vaccine
- More than 30 days since prior investigational vaccine
- More than 30 days since prior systemic steroid therapy
- No prior splenectomy
- More than 30 days since prior investigational drug
- More than 72 hours since prior antibiotic therapy for active infection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm I (SGN-00101)
Patients receive SGN-00101 vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
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Estudios correlativos
Given SC
Otros nombres:
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Comparador de placebos: Arm II (placebo)
Patients receive placebo vaccine SC on day 1 of weeks 1, 4, and 8 for a maximum of 3 injections in the absence of unacceptable toxicity or the development of an invasive malignancy or serious illness.
|
Estudios correlativos
Given SC
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HPV-16 viral load
Periodo de tiempo: 6 months
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Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model.
The univariate logistic regression model for infection resolution is equivalent to a chi-square test.
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6 months
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Natural history of HPV 16 viral load
Periodo de tiempo: Baseline
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A repeated measures version of the zero-inflated log-normal model will be constructed.
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Baseline
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Natural history of HPV 16 viral load
Periodo de tiempo: 3 months
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A repeated measures version of the zero-inflated log-normal model will be constructed.
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3 months
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Natural history of HPV 16 viral load
Periodo de tiempo: 6 months
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A repeated measures version of the zero-inflated log-normal model will be constructed.
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6 months
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Regression or non-regression of the cellular atypia
Periodo de tiempo: Up to 52 weeks
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The analysis for this will employ logistic regression models.
A multivariate logistic regression model will be constructed. .
A two group continuity corrected chi squared test with a 0.050 two-sided significance level will be used.
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Up to 52 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HPV-16 viral load
Periodo de tiempo: 3 months
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Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model.
The univariate logistic regression model for infection resolution is equivalent to a chi-square test.
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3 months
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Time to infection resolution
Periodo de tiempo: Up to 52 weeks
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Kaplan Meier curves will be constructed.
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Up to 52 weeks
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Time to disease resolution
Periodo de tiempo: Up to 52 weeks
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Kaplan Meier curves will be constructed.
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Up to 52 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Frank Meyskens, University of California Medical Center At Irvine-Orange Campus
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCI-2012-02623
- UCI#02-55
- N01CN25139 (Otro número de subvención/financiamiento: US NIH Grant/Contract Award Number)
- CDR0000383786 (Identificador de registro: PDQ (Physician Data Query))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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