- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01379430
Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas
Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults in a Malaria Endemic Area
The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50.
The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Kilifi, Quênia, PO Box 43640, 00100
- KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Consenting adult males aged 18-50 years in good health.
- Will remain resident in the study area for the study duration
Exclusion Criteria:
- Clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- History of splenectomy
- Haemoglobin less than 9.0 g/dl
- Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels, urine dipstick examination for blood and protein).
- Blood transfusion within one month of the beginning of the study
- History of vaccination with previous experimental malaria vaccines
- Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
- Current participation in another clinical trial, or within 12 weeks of this study
- Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
- Likelihood of travel away from the study area
- HIV positive.
- History of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the AdCh63 ME-TRAP vaccine, see the investigators brochure for details, attached)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Group 1
Intramuscular arm
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AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal
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Experimental: Group 2
Intradermal arm
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AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
Prazo: Participants will be followed for the duration of the study, an expected average of 12 months
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To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by recording local and systemic solicited and unsolicited adverse events
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Participants will be followed for the duration of the study, an expected average of 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Immunogenicity of vaccines
Prazo: Participants will be followed for the duration of the study, an expected average of 12 months
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To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by assessing induced antibody and T cell response to the vaccine insert.
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Participants will be followed for the duration of the study, an expected average of 12 months
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Immunogenicity of Vaccines
Prazo: Participants will be followed for the duration of the study, an expected average of 12 months
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To compare the use of intra-muscular and intra-dermal MVA ME-TRAP
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Participants will be followed for the duration of the study, an expected average of 12 months
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Colaboradores e Investigadores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VAC040
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 .
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