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1.
Vaccine ; 25(15): 2852-7, 2007 04 12.
Artigo em Inglês | MEDLINE | ID: mdl-17141380

RESUMO

The practicalities when applying the ICH GCPs (International Conference on Harmonization 1996 Good Clinical Practices [EU, MHLW, FDA. International Conference on Harmonization Guideline for Good Clinical Practice; 1997] in less developed countries (ldcs) are seldom discussed and we found no guidelines as how to "adapt" them. Below we illustrate how ICH GCP principles can be implemented in different settings. We have recently conducted in Asia (Hechi, China; Karachi, Pakistan; Hue, Vietnam; North Jakarta, Indonesia and Kolkata, India) large-scale cluster-randomized effectiveness evaluations of the Vi polysaccharide typhoid fever vaccine (Vi PS project) among approximately 200,000 individuals(1)[Acosta CJ, Galindo CM, Ali M, Abu-Elyazeed R, Ochiai RL Danovaro-Holliday MC et al. A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design. TMIH 2005;10(12):1219-1228]. There is no doubt on the importance of ICH GCP in its contribution to ethical and scientifically sound clinical research. However, when the ICH GCP is implemented in ldcs some considerations must be made in order to adequately tailor them. Vaccine trials in ldcs are a frequent setting for such challenges because of the increased global interest conducting health research in such countries. The ICH GCP principles are discussed below within the framework of this recent typhoid fever vaccine study experience.


Assuntos
Países em Desenvolvimento , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Vacinação/normas , Vacinas/administração & dosagem , Humanos , Polissacarídeos Bacterianos/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Vacinas Tíficas-Paratíficas/administração & dosagem
2.
Trop Med Int Health ; 10(12): 1219-28, 2005 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-16359401

RESUMO

Phase-III vaccine efficacy trials typically employ individually randomized designs intended to ensure that measurements of vaccine protective efficacy reflect only direct vaccine effects. As a result, decisions about introducing newly licensed vaccines into public health programmes often fail to consider the substantially greater protection that may occur when a vaccine is deployed in public health programmes, due to the combination of direct plus indirect vaccine protective effects. Vaccine total protection can be better evaluated with cluster randomized trials. Such a design was considered to generate policy relevant data to accelerate the rationale introduction of the licensed typhoid fever Vi polysaccharide (PS) vaccine in Asia by the Diseases of the Most Impoverished (DOMI) typhoid fever programme. The DOMI's programme multi-country study is one of the largest cluster randomized vaccine trials ever mounted in Asia, which includes approximately 200,000 individuals. Its main objective is to determine the effectiveness of a licensed Vi PS vaccine. The rationale and design of this study are discussed. Preliminary results are presented that determined the final planning of the trial before immunization. Important methodological and practical issues regarding vaccine cluster randomized designs are illustrated.


Assuntos
Polissacarídeos Bacterianos/uso terapêutico , Febre Tifoide/prevenção & controle , Vacinas Tíficas-Paratíficas/uso terapêutico , Adolescente , Adulto , Criança , Pré-Escolar , China/epidemiologia , Análise por Conglomerados , Países em Desenvolvimento , Humanos , Indonésia/epidemiologia , Lactente , Pessoa de Meia-Idade , Paquistão/epidemiologia , Aceitação pelo Paciente de Cuidados de Saúde , Polissacarídeos Bacterianos/efeitos adversos , Vigilância da População/métodos , Prevalência , Salmonella typhi/isolamento & purificação , Febre Tifoide/epidemiologia , Febre Tifoide/microbiologia , Vacinas Tíficas-Paratíficas/efeitos adversos , Vietnã/epidemiologia
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