A Study to Evaluate the Safety and Immunogenicity of Different Doses of ExPEC4V (JNJ-63871860) in Healthy Japanese Adult Participants
3 de octubre de 2016 actualizado por: Janssen Pharmaceutical K.K.
Randomized, Double-Blind, Placebo-controlled Phase 1 Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860
The purpose of this study is to assess the safety and tolerability of different doses of ExPEC4V (JNJ-63871860) in healthy Japanese participants greater than or equal to [> =] 20 years of age.
Descripción general del estudio
Descripción detallada
This is a Phase 1 double-blind (neither the Investigator nor the participant know the treatment), randomized (the study medication is assigned by chance), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) parallel group, single center study in healthy Japanese participants aged greater than or equal to [> =] 20 years.
A target of approximately 48 participants will be enrolled that are stratified according to their age in 2 groups: 24 participants > = 20 to less than [<] 50 years of age and 24 participants > = 50 years of age.
Both groups will be randomized to a single vaccination with 1 of the 3 study dose levels of ExPEC4V or placebo (vaccine buffer).
Participants will be enrolled in a dose ascending approach.
Blood samples will be drawn on Days 1 (prevaccination), 15 and 30 for the assessment of immunogenicity.
The study duration per participant will be approximately 38 days (Screening period and postvaccination follow-up included).
Participants' safety will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
48
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Fukuoka, Japón
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study
- Participant must be a man or woman greater than or equal to [> =] 20 years of age on the day of signing the ICF
- A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until at least 3 months after study vaccine administration. A male participant must agree not to donate sperm until at least 3 months after study vaccine administration
- Participant must have a body mass index (BMI: weight in kg divided by the square of height in meters) of less than or equal to [< =] 30.0 kg/m^2
- A male participant who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner uses occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Exclusion Criteria:
- Participant has a history of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy
- Participant has current or a history of autoimmune disease
- Participant has received an investigational drug (including investigational vaccines) within 90 days before vaccination in the study or is currently enrolled in an investigational study
- Participant has received treatment with immunoglobulins or blood products in the 4 months before vaccination in the study or any plans to receive such treatment during the study
- Participant has known or suspected congenital or acquired immunodeficiency (including leukemia, human immunodeficiency virus [HIV] seropositivity), has received immunosuppressive therapy (such as cyclosporine, anti-cancer chemotherapy, radiation therapy, or cytotoxic drugs) within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months, or has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen (HBsAg) and hepatitis C antibody, respectively
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Group 1
Participants with age (greater than or equal to [>=] 20 to less than [<] 50 years) will receive single dose of 0.5 milliliter (mL) of ExPEC4V (4:4:4:4) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Otros nombres:
Participant will receive single dose of Placebo on Day 1.
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Experimental: Group 2
Participants with age >= 20 to < 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Otros nombres:
Participant will receive single dose of Placebo on Day 1.
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Experimental: Group 3
Participants with age >= 20 to < 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Otros nombres:
Participant will receive single dose of Placebo on Day 1.
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Experimental: Group 4
Participants with age greater than or equal to [>=] 50 will receive single dose of 0.5 mL of ExPEC4V (4:4:4:4) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Otros nombres:
Participant will receive single dose of Placebo on Day 1.
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Experimental: Group 5
Participants with age >= 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Otros nombres:
Participant will receive single dose of Placebo on Day 1.
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Experimental: Group 6
Participants with age >= 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1.
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Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
Otros nombres:
Participant will receive single dose of Placebo on Day 1.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Up to follow-up (30 days)
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Up to follow-up (30 days)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Antibody Levels Against the ExPEC4V Measured by an Enzyme-Linked Immunosorbent Assay (ELISA)
Periodo de tiempo: Up to Day 30
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Up to Day 30
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Antibody Levels Against the ExPEC4V Measured by Opsonophagocytic Killing (OPK) Assay
Periodo de tiempo: Up to Day 30
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Up to Day 30
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2016
Finalización primaria (Actual)
1 de agosto de 2016
Finalización del estudio (Actual)
1 de agosto de 2016
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
20 de abril de 2016
Publicado por primera vez (Estimar)
22 de abril de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de octubre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
3 de octubre de 2016
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CR108139
- 63871860BAC1001 (Otro identificador: Janssen Pharmaceutical K.K., Japan)
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. .
Ensayos clínicos sobre ExPEC4V
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Janssen Research & Development, LLCTerminado
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Janssen Research & Development, LLCTerminado
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Janssen Research & Development, LLCTerminadoPrevención de Escherichia coli patógena extraintestinalEstados Unidos, Francia, Bélgica, España, Países Bajos