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Evaluation of immunogenicity and safety of yellow fever vaccine in adults with chronic renal disease

Grant number: 18/12237-9
Support type:Regular Research Grants
Duration: November 01, 2018 - October 31, 2020
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Marta Heloísa Lopes
Grantee:Marta Heloísa Lopes
Home Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
Assoc. researchers:Ana Marli Christovam Sartori ; Ligia Camera Pierrotti ; Luiz Sergio Fonseca de Azevedo ; Tania Leme da Rocha Martinez

Abstract

INTRODUCTION: Yellow fever transmission area is increasing to the East and South of Brazil since the beginning of the 2000s. In the end of 2016 - 2017, the country registered the biggest yellow fever outbreak of the last decades and epizooties, as well as human cases, increased in Sao Paulo State, with enlargement of the vaccine recommendation area. Yellow fever vaccine is a live attenuated vaccine that has contraindications. Chronic kidney disease is not a formal contraindication to vaccination, but there are only a few studies in this population. OBJECTIVES: The study objectives are to evaluate yellow fever vaccine safety and immunogenicity in adults with chronic kidney disease. METHODS: Two studies will be conducted: 1) Seroprevalence study of neutralizing anti-yellow fever antibodies in adults with chronic kidney disease previously vaccinated. Participants will be enrolled at the Nephrology Division of HC-FMUSP, e Nephrology Clinic of Hospital Beneficiência Portuguesa; 2) An open-label, controlled, non-randomized clinical trial. Adults with chronic kidney disease, in dialysis or not, who have not received yellow fever vaccine previously, and have vaccine recommendation for living or visiting area of yellow fever vaccine recommendation, will be enrolled at the Nephrology Clinic, Kidney Transplant Clinic and Immunization Center of Hospital das Clínicas da FMUSP. All participants will receive a single yellow fever vaccine dose after medical evaluation. Local and systemic adverse events following immunization (AEFI) will be evaluated in the 30 days following vaccination. Immune response to the vaccine will be evaluated 10 and 30 days and 12 months after vaccination using: rates (%) of seroconversion / four-fold increasing in neutralizing antibodies titers rates and neutralizing antibodies geometric mean titers. (AU)