Bio-Manguinhos/Fiocruz COVID-19 (mRNA) Vaccine Booster

This is a descriptive, open-label, multicenter, non-randomized, uncontrolled phase I clinical study to evaluate the safety, reactogenicity, and immunogenicity of the COVID-19 Vaccine (mRNA) - Bio-Manguinhos/Fiocruz at doses of 25 μg, 50 μg, and 100 μg in healthy adults aged 18 to 59 years. Each study cohort (25 μg, 50 μg, and 100 μg) will initially include a sentinel group of five participants, who will be included sequentially, one by one. This inclusion will allow for an initial integrated risk-benefit assessment, evaluating whether the data from the included participant maintain the risk within acceptable limits for progression.

Inclusion Criteria: 1. Men and women aged between 18 and 59 years. 2. Negative result for SARS-CoV-2 in a rapid antigen test at screening (Visit 1) and at the inclusion visit (Visit 0). 3. Body Mass Index \>18.9 and \20 mm/h for men \>30 mm/h for women; * ALT, AST, GGT or ALP \>1.25 × ULN; * Total bilirubin \>1.1 × ULN; * Urea \>1.1 × ULN; * Creatinine \>1.1 × ULN; * Glycated hemoglobin \>5.6%; * Troponin I \>1.1 × ULN; * PT or aPTT \>1.1 × ULN; • CPK above the ULN (men: \>174 U/L; women: \>140 U/L); * C-reactive protein \>1.0 mg/dL. 20. Resultado positivo em um ou mais exames de sorologia realizados na triagem.