Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment
Visão geral do estudo
Descrição detalhada
- Controlled trial study
- All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups.
group 1 : 25 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of equine rabies immune globulin (ERIG).
group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG).
group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).
5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab).
The GMTs of RNab among both groups would be analyzed and compared.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Bangkok, Tailândia, 10330
- Queen Saovabha Memorial Institute
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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:
- healthy volunteers age 18-60 years.
Exclusion Criteria:
- received prior rabies immunization
- pregnancy
- immunocompromised conditions
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Rabies vaccine, IM day 0,3,7,28 with RIG
Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 28 with equine rabies immunoglobulin 40 IU/Kg on day 0.
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Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Outros nomes:
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Experimental: Rabies vaccine, IM day 0,3,7,14 with RIG
Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 14 with equine rabies immunoglobulin 40 IU/Kg on day 0.
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Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Outros nomes:
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Comparador Ativo: Rabies vaccine, IM Day 0,3,7,14,28 with RIG
Rabies exposed victims receive rabies vaccination intramuscularly on Day 0,3,7,14,28 with equine rabies immunoglobulin 40 IU/Kg on day 0
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Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14
Prazo: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
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Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360.
Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
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Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28
Prazo: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
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Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7 and 28 would be determined on day 0,14, 28, 90 and 360.
Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
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Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Suda Sibunruang, MD, Queen Saovabha Memorial Institute
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 (Real)
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
- RC5502
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