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.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Complete primary vaccination for COVID-19, and at least one more booster dose, with the last booster being an mRNA vaccine approved by Anvisa.
. At least one booster dose with an mRNA-based vaccine, with the last booster given at least 6 months prior to the enrollment date (proven by a vaccination certificate or registration in the SI-PNI system).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety outcomes following experimental vaccination
Timeframe: Up to 7 days after vaccination.
Trial details
NCT IDNCT07640308
SponsorThe Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
. Participants with the potential to become pregnant (PPE), as well as men with PPE partners, must agree to use effective contraceptive methods throughout the study participation period.
. Ability to understand the study, its objectives, risks, and procedures, and to provide free and informed consent.
Exclusion criteria
. 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.
. Absolute or relative contraindications to the mRNA-based COVID-19 vaccine:
. Previous diagnosis of immunodeficiency, autoimmune diseases, or cardiomyopathies.
. Medium or large surgery performed up to 3 months prior to inclusion.
. History of malignant neoplasm in the 12 months prior to screening (V-1).
. Uncontrolled coagulopathy or any hematological condition that contraindicates intramuscular injection.
. Presence of decompensated or uncontrolled chronic disease at the time of inclusion. At the investigator's discretion, participants with stable chronic disease may be included.