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.
Men and women aged between 18 and 59 years.
Negative result for SARS-CoV-2 in a rapid antigen test at screening (Visit 1) and at the inclusion visit (Visit 0).
Body Mass Index >18.9 and <35.0 kg/m².
Body weight ≥50.0 kg for men and ≥45.0 kg for women.
Presence of any active infection at the time of vaccination or fever up to 7 days before the V0 visit. Participants in this condition may be rescheduled.
Administration of another vaccine up to 28 days before or planning to receive another vaccine within 29 days following the V0 visit.
Confirmed prior anaphylaxis to mRNA vaccines or any of their components, especially polyethylene glycol (PEG).
History of anaphylaxis to other vaccines or injectable medications.
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Lead sponsor
Oswaldo Cruz Foundation
Collaborator