ICAR Research Data Repository for Knowledge Management

The NIFTY trial sought to determine whether reducing the dosage of the vaccine can provide the same protection to the standard dosage given in Kenyan and Ugandan adults and children. The trial is registered at ClinicalTrials.gov. ID: NCT04059471.

This dataset relates to a trial to determine the safety and immune response elicited by the reduced doses of yellow fever vaccine in comparison to full dose of the vaccine in Kenyan and Ugandan adults. This was a parallel group, randomized, controlled, blinded, non-inferiority trial of four different doses of YF vaccine. The study was conducted at the KEMRI CGMRC in Kilifi, Kenya and at Epicentre in Mbarara, Uganda. Both these sites had already worked together in study (Clinicaltrials.gov number: NCT02991495).Adult participants (n=480) was randomized for vaccination with full standard dose or with 1000,500 or 250 IU (i.e. 4 arms) with a 1:1:1:1 allocation ratio. Adult vaccinees was followed up for 2 years. This data was captured in paper Case report forms(CRFs) stored in secure lockable cabinets by study clinicians and later transcribed into eCRFs using REDCap database by data entry clerks located at each site. Data export to create analysis was done using STATA statistical software.