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.

NCT Number	NCT07640308
Lead Sponsor	The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) Collaborators: Oswaldo Cruz Foundation
Conditions	Severe Acute Respiratory Syndrome (SARS-CoV-2 Virus)
Enrollment	90 participants
Start Date	2026-07
Primary Completion	2027-07 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-10