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.
Parallel
Grupo 1 - dose 25 μg
Biological/VaccineAdministration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 25 μg (single intramuscular dose)
Group 2 - 50 μg dose
Biological/VaccineAdministration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 50 μg (single intramuscular dose)
Group 3 - 100 μg
Biological/VaccineAdministration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 100 μg (single intramuscular dose)
Safety outcomes following experimental vaccination
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\].
Assessment of cellular and humoral safety and immunity.
Incidence, severity, intensity, and causality of adverse events reported at 28, 90, and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Increase relative to V0 values of the geometric mean of neutralizing antibody titers against the XBB variant and variants of interest at the time of conducting the study at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Percentage of participants with an increase of 4 times or more in relation to the V0 values in neutralizing antibody titers against the XBB variant and variants of interest at the time of conducting the study at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Increase in relation to V0 values of the geometric mean of the titer of total antibodies (IgG) specific to the RBD portion of the XBB S protein at 7, 28, 90 and 180 days after vaccination.
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The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Lead sponsor
Oswaldo Cruz Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
