Clinical Trial for the Evaluation of Three Regimens of Influenza Vaccination in Kidney Transplant Recipients

Summary

This will be an open label, parallel, randomized clinical trial that will evaluate the immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented) produced by Instituto Butantan among adult kidney transplant recipients, when administered in three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two doses administered with a 21 day interval. The randomization ratio among the three groups of kidney transplant recipients will be 1:1, and 60 participants will be included in each group. After vaccination all participants will be followed for 26 weeks. In addition, 15 healthy adults will be included as a control group, and will receive the recommended dose. The study hypothesis is that a different vaccination regimen can improve the immune response of kidney transplant recipients after vaccination with the trivalent influenza vaccine (inactivated and fragmented).

Timeline

Start

2014-04

Primary completion

2014-08

Completion

2015-03

Publications

• Odongo FCA, Braga PE, Palacios R, Miraglia JL, Sartori AMC, Ibrahim KY, Lopes MH, Caiaffa-Filho HH, Timenetsky MDCST, Agena F, Fonseca de Azevedo LS, David-Neto E, Precioso AR, Pierrotti LC. An Open-label Randomized Controlled Parallel-group Pilot Study Comparing the Immunogenicity of a Standard-, Double-, and Booster-dose Regimens of the 2014 Seasonal Trivalent Inactivated Influenza Vaccine in Kidney Transplant Recipients. Transplantation. 2022 Jan 1;106(1):210-220. doi: 10.1097/TP.0000000000003702.

Drugs

Indications