- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02325050
A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
12 de junho de 2017 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
164
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Maryland
-
Rockville, Maryland, Estados Unidos
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Número de participantes com reatogenicidade (ou seja, eventos adversos locais e sistêmicos solicitados)
Prazo: 1 semana após a administração de cada vacina do estudo
|
1 semana após a administração de cada vacina do estudo
|
Number of participants with adverse events
Prazo: Up to 21 days after the last vaccination (up to Day 381)
|
Up to 21 days after the last vaccination (up to Day 381)
|
Number of participants with serious adverse events
Prazo: Up to the end of long term follow-up (up to Day 720)
|
Up to the end of long term follow-up (up to Day 720)
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Immune responses to the study vaccine regimens as measured by a virus neutralization assay
Prazo: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunosorbent assay (ELISA)
Prazo: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
Immune responses to the study vaccine regimens as measured by an enzyme-linked immunospot (ELISpot) assay
Prazo: up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
up to Day 720 (Group 1-8); Day 360 (Group 9, 10)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de janeiro de 2015
Conclusão Primária (Real)
2 de julho de 2015
Conclusão do estudo (Real)
8 de maio de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
19 de dezembro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de dezembro de 2014
Primeira postagem (Estimativa)
24 de dezembro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de junho de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2017
Última verificação
1 de junho de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- CR106479
- VAC52150EBL1002 (Outro identificador: Janssen Vaccines & Prevention B.V.)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em MVA-BN-Filo
-
Janssen Vaccines & Prevention B.V.National Institute of Allergy and Infectious Diseases (NIAID)Concluído
-
MRC/UVRI and LSHTM Uganda Research UnitEpicentre, Paris, France.; Janssen Pharmaceutica N.V., Belgium; Coalition for... e outros colaboradoresConcluído
-
University of OxfordNational Institute of Allergy and Infectious Diseases (NIAID); Wellcome TrustConcluídoEbola | Ebola ZaireReino Unido
-
Janssen Vaccines & Prevention B.V.Institut National de la Santé Et de la Recherche Médicale, France; Centre Muraz e outros colaboradoresConcluídoFebre Hemorrágica, EbolaQuênia, Uganda, Burkina Faso, Costa do Marfim
-
Janssen Vaccines & Prevention B.V.Walter Reed Army Institute of Research (WRAIR)ConcluídoFebre Hemorrágica, EbolaEstados Unidos, Uganda, Quênia, Moçambique, Nigéria, Tanzânia
-
Crucell Holland BVConcluído
-
London School of Hygiene and Tropical MedicinePublic Health England; Janssen Vaccines & Prevention B.V.; Epicentre; Coalition... e outros colaboradoresAtivo, não recrutandoDoença do Vírus EbolaCongo, República Democrática do
-
Janssen Vaccines & Prevention B.V.Institut National de la Santé Et de la Recherche Médicale, France; University...Concluído
-
Janssen Vaccines & Prevention B.V.Emory University; Coalition for Epidemic Preparedness Innovations; Center for...Concluído
-
Crucell Holland BVConcluído