Historical review of clinical vaccine studies at Oswaldo Cruz Institute and Oswaldo Cruz Foundation--technological development issues.
This paper presents, from the perspective of technological development and production, the results of an investigation examining 61 clinical studies with vaccines conducted in Brazil between 1938-2013, with the participation of the Oswaldo Cruz Institute (IOC) and the Oswaldo Cruz Foundation (Fiocruz). These studies have been identified and reviewed according to criteria, such as the kind of vaccine (viral, bacterial, parasitic), their rationale, design and methodological strategies. The results indicate that IOC and Fiocruz have accumulated along this time significant knowledge and experience for the performance of studies in all clinical phases and are prepared for the development of new vaccines products and processes. We recommend national policy strategies to overcome existing regulatory and financing constraints.
Bio-Manguinhos-Fiocruz, Rio de Janeiro, RJ, Brasil.
Reinaldo de Menezes
Rde M
Martins
Bio-Manguinhos-Fiocruz, Rio de Janeiro, RJ, Brasil.
Cristina de Albuquerque
Cde A
Possas
Bio-Manguinhos-Fiocruz, Rio de Janeiro, RJ, Brasil.
Akira
A
Homma
D000047:Academies and Institutes / Q000266:history*; D001428:Bacterial Vaccines / Q000266:history* / Q000627:therapeutic use; D001938:Brazil; D002986:Clinical Trials as Topic / Q000266:history*; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D016052:Protozoan Vaccines / Q000266:history* / Q000627:therapeutic use; D012106:Research; D013678:Technology, Pharmaceutical / Q000379:methods / Q000639:trends; D014765:Viral Vaccines / Q000266:history* / Q000627:therapeutic use
D001428:Bacterial Vaccines; D016052:Protozoan Vaccines; D014765:Viral Vaccines