Study Design and Participants
chronic kidney disease, chronic liver disease
MAY, TYPE 2 DIABETES, CHRONIC LIVER DISEASE, HYPERTENSION
A multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 clinical trial was conducted to evaluate the efficacy, safety, and immunogenicity of a 2-dose regimen of conjugated protein-based FINLAY-FR-2, 25 μg, in one cohort (cohort 1) and a 2-dose regimen of FINLAY-FR-2 with a third dose of FINLAY-FR-1A, 50 μg, in a second cohort (cohort 2) in Iran. The study was conducted from April 26 to September 25, 2021. The trial protocol was reviewed and approved by Iran’s Food and Drug Administration and the National Committee for Ethics in Biomedical Research. The study followed the Consolidated Standards of Reporting Trials (Participants were recruited from 8 geographically dispersed cities between April 26 and May 23, 2021 (eFigure 1 in Volunteers aged 18 to 80 years without a current clinical presentation or laboratory-confirmed COVID-19 or history of COVID-19 vaccination, congenital or uncontrolled type 2 diabetes, chronic kidney disease, hypertension, and chronic liver disease could be included. The details of eligibility criteria are provided in the trial protocol (During the study, Iran initiated an immediate COVID-19 vaccination program, prioritizing older adults (≥65 years). To comply with the ethical principles,