Centro de Pesquisas René Rachou - FIOCRUZ/MG

Experience

The site enjoys an international reputation for the study of the immunology of helminthic infections in human populations. The speciality of the Lab is in the study of the immune cellular and humoral responses in areas of the Minas Gerais State, Brazil, that are endemic for helminths.

Research interests

The institution has been involved in numerous collaborative projects over the years, including projects supported by the NIH, European
Economic Community and the World Health Organization. Most recently, this year CPqRR was awarded a Tropical Medicine Research Center (TMRC) grant from the NIAID. These are testimony to the institute's commitment to international research projects. In addition, this site has been the Major Foreign Collaborator on an International Collaborations in Infectious Disease R esearch (ICIDR) grant for the past 13 years.

Disease areas

• Enteric diseases
• Helminths
• Influenza
• Leishmaniasis

Other information

The Centro de Pesquisas René Rachou (CPqRR, FIOCRUZ in Minas Gerais) is located in the urban center of Belo Horizonte, a city of approximately 4 million inhabitants. CPqRR has two major outpatient facilities at its disposal: one at the research institute in Belo Horizonte, and the other in at a field site located in a rural part of the northeastern region of Minas Gerais where intestinal helminths, Dengue, leprosy, and visceral and cutaneous leishmaniasis are endemic. In addition to the facilities at CPqRR in Belo Horizonte, CPqRR has also invested in dedicated clinical facilities for conducting clinical trials of investigational products in the town Americaninhas . At the field site in Americaninhas, the CPqRR has built a vaccine testing center in the town for the conduct of vaccine and other clinical trials. The facilities both in Belo Horizonte and in Americaninhas have access to emergency care and accommodations in the event of serious or other adverse events that require such management. In addition, the CPqRR has an agreement in place with a tertiary care hospital (Hospital Santa Rosalia) in the nearby city of Téofilo Otoni to transport study subjects in a fully equipped ambulance from Americaninhas to Téofilo Otoni. Both CPqRR clinical trial sites in Belo Horizonte and Americaninhas utilize clinical laboratory facilities that have been accredited by the Brazilian Association of Pathologists, the certifying body for clinical laboratories in Brazil. CPqRR staff that are delegated to handling clinical specimens are trained in the collection, processing and storing of clinical specimens. This training is conducted and renewed annually and is documented in each employee’s personnel file. SOPs have been written for each of these procedures and are reviewed and updated annually, as necessary. CPqRR has research laboratory facilities both at its field site in Americaninhas as well as at the CPqRR institute in Belo Horizonte. In Americaninhas, researcher from CPqRR and GWU have established a field laboratory for performing high quality parasitological examinations, such as microscopic fecal examination for helminth eggs, and preservation of serum, plasma, and RFP peripheral blood mononuclear cells for subsequent immunological studies. Because this lab processes and performs assays on clinical specimens collected from subjects participating in clinical trials that will be instrumental in providing evidence of safety, immunogenicity and efficacy of experimental vaccines for helminths, strict quality control and quality assurance systems have been established, with documentation that conforms to both US FDA and Brazilian regulatory standards for submission to IND/NDA/BLAs. This quality management system ensures that all lab operations are properly documented with Standard Operating Procedures for all tests conducted in the laboratory and maintaining current training records. This field laboratory has been inspected by several groups of external monitors with excellent reviews. In addition to this high-quality field laboratory, CPqRR and GWU have also established a Laboratory of Clinical Immunology (CIL) located within the Laboratory of Cellular and Molecular Immunology (LICM) at CPqRR in Belo Horizonte. The primary purpose of this laboratory is to develop and qualify standardized assays to study the immune response both to natural infection with hookworm and other helminths, and also to vaccines against helminth infections. The work of the CIL will be crucial in establishing immunological correlates of protection that can be used to determine vaccine efficacy in the future. All of these assays will be important in supporting the regulatory filings for the vaccines being developed, both at the initiation of clinical testing and all the way through licensure. The quality of the CIL’s work is therefore of a standard that has been deemed acceptable by regulatory agencies such as the Agência Nacional de Vigilância Sanitária (ANVISA).