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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02325050
A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
12 de junio de 2017 actualizado por: Janssen Vaccines & Prevention B.V.
A Phase 1, Randomized, Placebo-Controlled, Observer-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous and Homologous Prime-Boost Regimens Using MVA-BN-Filo® and Ad26.ZEBOV Administered in Different Doses, Sequences and Schedules in Healthy Adult Subjects
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study consists of 3 parts: the first and third part with standard doses and the second part with higher doses.
All parts are randomized, placebo-controlled, observer-blind to evaluate the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different doses, sequences and schedules to healthy adult participants.
The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29, or 57, and third vaccine 1-year post-prime (3rd vaccination is optional for subjects in groups 1-8).
The total duration of the study will be about 1 year for participants who wiil receive boost vaccine and about 3 months for participants who will receive placebo and 2 year for participants who will receive a 3rd dose.
Safety will be monitored during the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
164
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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Maryland
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Rockville, Maryland, Estados Unidos
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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
18 años a 50 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Must be healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
- Have a body mass index (BMI) ≥18.5 and <35.0 kg/m2
- Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening, a negative urine pregnancy test immediately prior to each study vaccine administration, and practice adequate birth control measures from 28 days before the prime vaccination until at least 3 months after the boost vaccination as specified in the study protocol. If not heterosexually active at screening, must agree to practice adequate birth control measures if they become heterosexually active during their participation in the study (from screening onwards until at least 3 months after the boost vaccination). Agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during participation in the study (from screening onwards until at least 3 months after the boost vaccination)
- Women of non-childbearing potential, defined as postmenopausal (>45 years of age with amenorrhea for ≥2 years or any age with amenorrhea for ≥6 months and serum follicle-stimulating hormone [FSH] >40 mIU/mL) or surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), are not required to use the birth control methods as specified in the study protocol
- A man who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use a double-barrier method of birth control, such as either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. In case the female partner is using an adequate method of birth control, a single-barrier method of birth control for the male subject is acceptable. Men must also agree not to donate sperm during their participation in the study (from screening onwards until at least 3 months after the boost vaccination)
- Must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted
Exclusion Criteria:
- Has been vaccinated with a candidate Ebola vaccine
- Has been diagnosed with Ebola disease or exposed to Ebola including travel to West Africa in the last 12 months. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone. Participants who anticipate traveling to epidemic Ebola areas before the start of the long-term follow-up period will also be excluded from enrollment into the study
- Has received any Ad26- or MVA-based candidate vaccine in the past
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines), including known allergy to egg or aminoglycosides
- A woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in the study or within 3 months after the boost vaccination
- History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone; thyroidectomy, or thyroid disease requiring medication during the last 12 months; uncontrolled hypertension as defined in the study protocol; or, major psychiatric illness and/or substance abuse problems during the past 12 months that in the opinion of the investigator would preclude participation
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Group 1
Participants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 15) or Placebo (Day 1/Day 15).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 2
Participants will receive MVA-BN-Filo/Ad26.ZEBOV (Day 1 /Day 29) or placebo (Day 1/Day 29).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 3
Participants will receive MVA-BN-Filo /Ad26.ZEBOV/ (Day 1/Day 57) or placebo (Day 1/Day 57).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 4
Participants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 5
Participants will receive MVA-BN-Filo (Day 1 and Day 15) or placebo (Day 1 and Day 15).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 6
Participants will receive Ad26.ZEBOV (Day 1 and Day 15) or placebo (Day 1 and Day 15).
Participants will receive MVA-BN-Filo (1*10^8 TCID50) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 7
Participants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1/Day 15) or Placebo (Day 1/Day 15).
Participants will receive Ad26.ZEBOV (5x10^10 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 8
Participants will receive Ad26.ZEBOV/ MVA-BN-Filo (Day 1 /Day 29) or Placebo (Day 1/Day 29).
Participants will receive Ad26.ZEBOV (1x10^11 vp) on Day 360.
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 9
Participants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 8) or Placebo (Day 1/Day 8).
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
|
Experimental: Group 10
Participants will receive MVA-BN-Filo/ Ad26.ZEBOV (Day 1 /Day 15) or Placebo (Day 1/Day 15).
|
One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 5*10^10 viral particles (vp).
One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
One 0.5 mL IM injection of 1*10^11 viral particles (vp).
One 0.5 mL IM injection of 0.9% saline.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Número de participantes con reactogenicidad (es decir, eventos adversos locales y sistémicos solicitados)
Periodo de tiempo: 1 semana después de la administración de cada vacuna del estudio
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1 semana después de la administración de cada vacuna del estudio
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Number of participants with adverse events
Periodo de tiempo: Up to 21 days after the last vaccination (up to Day 381)
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Up to 21 days after the last vaccination (up to Day 381)
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Number of participants with serious adverse events
Periodo de tiempo: Up to the end of long term follow-up (up to Day 720)
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Up to the end of long term follow-up (up to Day 720)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Immune responses to the study vaccine regimens as measured by a virus neutralization assay
Periodo de tiempo: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
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up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
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Immune responses to the study vaccine regimens as measured by an enzyme-linked immunosorbent assay (ELISA)
Periodo de tiempo: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
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up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
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Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay
Periodo de tiempo: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
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up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
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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 (Actual)
8 de enero de 2015
Finalización primaria (Actual)
2 de julio de 2015
Finalización del estudio (Actual)
8 de mayo de 2017
Fechas de registro del estudio
Enviado por primera vez
19 de diciembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
19 de diciembre de 2014
Publicado por primera vez (Estimar)
24 de diciembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de junio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
- La seguridad
- Saludable
- Inmunogenicidad
- Virus del Ébola
- Enfermedad viral del Ébola (EVE)
- Filovirus
- Adenovirus humano serotipo 26 (Ad26) que expresa la glicoproteína variante Mayinga del virus del Ébola (Ad26.ZEBOV)
- Virus vaccinia modificado Ankara - Nórdico bávaro (MVA-BN) Filo-vector
- vacuna monovalente
Otros números de identificación del estudio
- CR106479
- VAC52150EBL1002 (Otro identificador: Janssen Vaccines & Prevention B.V.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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 MVA-BN-Filo
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Janssen Vaccines & Prevention B.V.National Institute of Allergy and Infectious Diseases (NIAID)Terminado
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MRC/UVRI and LSHTM Uganda Research UnitEpicentre, Paris, France.; Janssen Pharmaceutica N.V., Belgium; Coalition for Epidemic... y otros colaboradoresTerminadoEnfermedad del virus del ÉbolaUganda
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University of OxfordNational Institute of Allergy and Infectious Diseases (NIAID); Wellcome TrustTerminadoÉbola | Ébola ZaireReino Unido
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Janssen Vaccines & Prevention B.V.Institut National de la Santé Et de la Recherche Médicale, France; Centre Muraz; EBOVAC2 ConsortiumTerminadoFiebre Hemorrágica, ÉbolaKenia, Uganda, Burkina Faso, Costa de Marfil
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Janssen Vaccines & Prevention B.V.Walter Reed Army Institute of Research (WRAIR)TerminadoFiebre Hemorrágica, ÉbolaEstados Unidos, Uganda, Kenia, Mozambique, Nigeria, Tanzania
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Crucell Holland BVTerminado
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London School of Hygiene and Tropical MedicinePublic Health England; Janssen Vaccines & Prevention B.V.; Epicentre; Coalition for... y otros colaboradoresActivo, no reclutandoEnfermedad del virus del ÉbolaCongo, República Democrática del
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Janssen Vaccines & Prevention B.V.Institut National de la Santé Et de la Recherche Médicale, France; University...TerminadoEnfermedad viral del ébolaFrancia, Reino Unido
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Janssen Vaccines & Prevention B.V.Emory University; Coalition for Epidemic Preparedness Innovations; Center for Family...Terminado
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Crucell Holland BVTerminado