- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02926430
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
18 de fevereiro de 2019 atualizado por: Janssen Vaccines & Prevention B.V.
A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF,
administered intramuscularly to elderly adults given approximately 12 months apart.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
73
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
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Florida
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Miami, Florida, Estados Unidos
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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
60 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; and not intending to conceive by any methods
- From the time of first vaccination until 3 months after the first dose of study vaccine, and from the second vaccination through 3 months after, a man who has not had a vasectomy (or if a vasectomy was performed less than 1 year ago and the absence of sperm cannot be verified)
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grades 1 or 2 according to the US Food and Drug Administration (FDA) toxicity tables (for tests in the FDA table ), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Exclusion Criteria:
- Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree celsius within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
- Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
- Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1
Participants will receive 5*10^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
Outros nomes:
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Experimental: Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2
Participants will receive 5*10^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
Outros nomes:
Participants will receive placebo as formulation buffer.
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Experimental: Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3
Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
Outros nomes:
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Experimental: Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4
Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
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Participants will receive placebo as formulation buffer.
Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
Outros nomes:
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Experimental: Placebo (Day 1 and Day 365): Group 5
Participants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination).
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Participants will receive placebo as formulation buffer.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
Prazo: 7 days after each vaccination (Day 1)
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7 days after each vaccination (Day 1)
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Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
Prazo: 7 days after each vaccination (Day 365)
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7 days after each vaccination (Day 365)
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Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
Prazo: 7 days after each vaccination (Day 1)
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7 days after each vaccination (Day 1)
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Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
Prazo: 7 days after each vaccination (Day 365)
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7 days after each vaccination (Day 365)
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Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Prazo: 28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
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Number of Participants With Serious Adverse Events (SAEs) Throughout Study
Prazo: Up to 730 days
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Up to 730 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Respiratory Syncytial Virus (RSV) Neutralization A2
Prazo: Days 1, 29, 183, 365, 393, 547, 730
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Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed.
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Days 1, 29, 183, 365, 393, 547, 730
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RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay
Prazo: Days 1, 29, 183, 365, 393, 547, 730
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Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form.
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Days 1, 29, 183, 365, 393, 547, 730
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Intracellular Cytokine Staining
Prazo: Day 1, 29, 183, 365, 393, 547, 730
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The activation of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV protein peptide stimulation (including, but not limited to CD4/CD8, interleukin [IL-2], interferon gamma [IFN gamma], tumor necrosis factor alpha [TNF-alpha] and/or activation markers, memory, T-helper [cells] Th1/Th2 subtyping).
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Day 1, 29, 183, 365, 393, 547, 730
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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 novembro de 2016
Conclusão Primária (Real)
14 de março de 2018
Conclusão do estudo (Real)
29 de janeiro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
22 de setembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de outubro de 2016
Primeira postagem (Estimativa)
6 de outubro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de fevereiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de fevereiro de 2019
Última verificação
1 de fevereiro de 2019
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- CR108214
- VAC18193RSV1003 (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
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