Severe Acute Respiratory Syndrome (SARS-CoV-2 Virus)Phase 1NCT07640308
Bio-Manguinhos/Fiocruz COVID-19 (mRNA) Vaccine Booster
A Phase 1 study testing Grupo 1 - dose 25 μg, Group 2 - 50 μg dose and Group 3 - 100 μg in people with Severe Acute Respiratory Syndrome (SARS-CoV-2 Virus), run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Severe Acute Respiratory Syndrome (SARS-CoV-2 Virus)
- What is being tested?
- Grupo 1 - dose 25 μg, Group 2 - 50 μg dose and Group 3 - 100 μg
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
- 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.
Who cannot join
- 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:
- Confirmed prior anaphylaxis to mRNA vaccines or any of their components, especially polyethylene glycol (PEG).
- History of anaphylaxis to other vaccines or injectable medications.
- History of myocarditis or pericarditis prior to vaccination.
Show all 36Show fewer
- History of multisystem inflammatory syndrome (MIS-C or MIS-A).
- 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.
- Use of immunosuppressive medications in the 3 months prior to vaccination.
- History of antineoplastic chemotherapy treatment.
- Planning for the use of immunosuppressants or chemotherapeutic agents during the study period.
- Current use of corticosteroids at immunosuppressive doses. Immunosuppressive doses are considered to be ≥10 mg/day of prednisone (or equivalent) systemically for 14 days or more.
- Use of blood products in the 3 months prior to inclusion.
- Participation in another clinical study using an investigational product in the 12 months prior to inclusion.
- Pregnancy or lactation at the time of visit V0, or planning to become pregnant during the study period.
- Positive pregnancy test result at screening (visit V1) or on the day of vaccination (applicable to PEP).
- Presence of tattoos, scars, discoloration, or any skin alteration at the application site that, in the investigator's opinion, may interfere with the assessment of local reactogenicity.
- Any medical, psychological, or social condition that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the integrity of the data.
- Clinically significant changes in screening laboratory tests (visit V1):
- Hemoglobin ≤ 10.9 g/dL;
- White blood cells < 2,500 cells/mm³;
- Absolute neutrophils < 1,000 cells/mm³;
- ESR above the upper limit of normal (ULN) >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.
- Resultado positivo em um ou mais exames de sorologia realizados na triagem.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Bio-Manguinhos/Fiocruz COVID-19 (mRNA) Vaccine Booster in Healthy Adults
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.
Read the detailed description
The inclusion of cohorts, defined by dose, will be carried out in a staggered manner in the following order:
Sentinel group 1 (25 μg dose): Analysis of reactogenicity and safety data from 5 participants, who will be included one at a time and evaluated 48 hours after administration of the investigational product. The safety data from these participants will be obtained 7 days after vaccination and evaluated by the CMDS to allow the inclusion of the remaining 25 participants from this dose, as well as the participants from the sentinel group of the 50 μg dose.
Sentinel group 2 (50 μg dose): Analysis of reactogenicity and safety data from 5 participants, who will be included one at a time and evaluated 48 hours after administration of the investigational product. Safety data from these participants will be obtained 7 days after vaccination and evaluated by the CMDS to allow the inclusion of the remaining 25 participants from this dose, as well as the participants from the sentinel group of the 100 μg dose.
Sentinel Group 3 (100 μg dose): Analysis of reactogenicity and safety data from 5 participants, who will be included one at a time and evaluated 48 hours after administration of the investigational product. Safety data from these participants will be obtained 7 days after vaccination and evaluated by the CMDS to allow the inclusion of the remaining 25 participants in this dose.
At the end of this period, a formal cumulative safety review will be conducted by the Data and Safety Monitoring Committee (CMDS), which will evaluate all available safety data from the sentinel group, including: solicited and unsolicited adverse events; serious adverse events; severe adverse events; vital signs; laboratory data; and any other relevant clinical findings. The CMDS will issue a documented report recommending or not the continuation of the study.
The study population will consist of 90 adult participants who received complete primary vaccination for COVID-19, and at least one additional booster dose, the last booster being an mRNA vaccine approved by ANVISA, administered at least 6 months prior to inclusion.
The study design was based on the European Medicines Agency - EMA guideline, ANVISA-RDC 945/2024 and Law 14.874/2024 [4] and other phase I clinical studies of RNA-based vaccines for COVID-19.
Data from this study will support decisions on whether the candidate vaccine should be further evaluated in advanced phase clinical trials, guide dose selection, and support platform development. If the monovalent candidate induces potentially protective immune responses with an acceptable safety profile, there may be potential to develop future multivalent vaccines to prevent COVID-19 disease based on this platform.
The clinical study will begin immediately after ethical and regulatory approvals. The participant inclusion period is estimated to be 6 months. Follow-up of each participant will require another 6 months. Therefore, the total time required between the first visit of the first participant included and the last visit of the last participant is approximately 12 months.
Description of the Experimental Intervention: The COVID-19 Vaccine (mRNA) - Bio-Manguinhos/Fiocruz is a monovalent vaccine for the prevention of severe cases of COVID-19. The product under investigation consists of a formulation containing messenger ribonucleic acid (mRNA) encoding the Spike protein of the XBB variant of the SARS-CoV-2 virus.
Randomization: There will be no randomization in this study. Blinding/Breaking of Blinding: The study is open-label. There will be no blinding.
- Being tested
- Grupo 1 - dose 25 μg, Group 2 - 50 μg dose, Group 3 - 100 μg
- Keywords
- mRNA Platform, COVID-19
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grupo 1 - dose 25 μgBiological
Administration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 25 μg (single intramuscular dose)
Group 2 - 50 μg doseBiological
Administration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 50 μg (single intramuscular dose)
Group 3 - 100 μgBiological
Administration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 100 μg (single intramuscular dose)
| Study group | Role | What they receive |
|---|---|---|
| Group 1- 25 μg dose | Experimental | Group consisting of 30 participants (5 from the sentinel group + 25 participants). This group will receive the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 25 μg. Receives: Biological: Grupo 1 - dose 25 μg |
| Group 2 - 50 μg dose | Experimental | Group consisting of 30 participants (5 from the sentinel group + 25 participants). This group will receive the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 50 μg. Receives: Biological: Group 2 - 50 μg dose |
| Group 3 - 100 μg dose | Experimental | Group consisting of 30 participants (5 from the sentinel group + 25 participants). This group will receive the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 100 μg. Receives: Biological: Group 3 - 100 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcomes following experimental vaccination
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Measured: Up to 7 days after vaccination.
Secondary outcomes (10)
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.
Measured: 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.
Measured: Reported 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.
Measured: Reported 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.
Measured: Reported 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 compared to V0 values in total antibody levels (IgG) specific to the RBD portion of the XBB S protein at 7, 28, 90, and 180 days after vaccination.
Measured: Reported at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Evaluation of the profile of T cells producing IFN-γ, IL-2, and IL-4 in PBMC cultures stimulated with the XBB variant and variants of interest at the time of conducting the study at 7, 28, 90, and 180 days after vaccination.
Measured: Reported at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Identification of differentially expressed genes related to vaccine safety, 7 days after vaccination.
Measured: Reported at 7 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Comparison of serum IL-2, IL-4, IL-5, IL-10, TNF-α, and IFN-γ quantifications with respect to V0 values, 7, 28, 90, and 180 days after vaccination.
Measured: Reported at 7, 28, 90, and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Comparison of V0 values of the antibody avidity index for XBB and variants of interest at the time of conducting the study at 7, 28, 90, and 180 days after vaccination.
Measured: Reported at 7, 28, 90, and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Comparison of V0 values of the percentages of cells from the subpopulations of T and B cells in PBMC cultures stimulated with the XBB variant and variants of interest at the time of conducting the study at 7, 28, 90 and 180 days after vaccination.
Measured: Reported at 7, 28, 90, and 180 days after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome (SARS-CoV-2 Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Descriptive phase I clinical study, open-label, multicenter, non-randomized, uncontrolled.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Responsible party
- Sponsor
- Investigators
- Maria de Lourdes de Sousa Maia, Physician, Study director, Oswaldo Cruz Foundation/Bio-Manguinhos Immunobiological InstituteMarcellus Dias da Costa, Infectious disease physician, Principal investigator, Evandro Chagas National Institute of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640308
- Sponsor's protocol ID
- DEAME 002/2025
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Bio-Manguinhos/Fiocruz COVID-19 (mRNA) Vaccine Booster in Healthy Adults
- ClinicalTrials.gov ID
- NCT07640308
- Acronym / sponsor ID
- DEAME 002/2025
- Keywords
- mRNA Platform, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The inclusion of cohorts, defined by dose, will be carried out in a staggered manner in the following order:
Sentinel group 1 (25 μg dose): Analysis of reactogenicity and safety data from 5 participants, who will be included one at a time and evaluated 48 hours after administration of the investigational product. The safety data from these participants will be obtained 7 days after vaccination and evaluated by the CMDS to allow the inclusion of the remaining 25 participants from this dose, as well as the participants from the sentinel group of the 50 μg dose.
Sentinel group 2 (50 μg dose): Analysis of reactogenicity and safety data from 5 participants, who will be included one at a time and evaluated 48 hours after administration of the investigational product. Safety data from these participants will be obtained 7 days after vaccination and evaluated by the CMDS to allow the inclusion of the remaining 25 participants from this dose, as well as the participants from the sentinel group of the 100 μg dose.
Sentinel Group 3 (100 μg dose): Analysis of reactogenicity and safety data from 5 participants, who will be included one at a time and evaluated 48 hours after administration of the investigational product. Safety data from these participants will be obtained 7 days after vaccination and evaluated by the CMDS to allow the inclusion of the remaining 25 participants in this dose.
At the end of this period, a formal cumulative safety review will be conducted by the Data and Safety Monitoring Committee (CMDS), which will evaluate all available safety data from the sentinel group, including: solicited and unsolicited adverse events; serious adverse events; severe adverse events; vital signs; laboratory data; and any other relevant clinical findings. The CMDS will issue a documented report recommending or not the continuation of the study.
The study population will consist of 90 adult participants who received complete primary vaccination for COVID-19, and at least one additional booster dose, the last booster being an mRNA vaccine approved by ANVISA, administered at least 6 months prior to inclusion.
The study design was based on the European Medicines Agency - EMA guideline, ANVISA-RDC 945/2024 and Law 14.874/2024 [4] and other phase I clinical studies of RNA-based vaccines for COVID-19.
Data from this study will support decisions on whether the candidate vaccine should be further evaluated in advanced phase clinical trials, guide dose selection, and support platform development. If the monovalent candidate induces potentially protective immune responses with an acceptable safety profile, there may be potential to develop future multivalent vaccines to prevent COVID-19 disease based on this platform.
The clinical study will begin immediately after ethical and regulatory approvals. The participant inclusion period is estimated to be 6 months. Follow-up of each participant will require another 6 months. Therefore, the total time required between the first visit of the first participant included and the last visit of the last participant is approximately 12 months.
Description of the Experimental Intervention: The COVID-19 Vaccine (mRNA) - Bio-Manguinhos/Fiocruz is a monovalent vaccine for the prevention of severe cases of COVID-19. The product under investigation consists of a formulation containing messenger ribonucleic acid (mRNA) encoding the Spike protein of the XBB variant of the SARS-CoV-2 virus.
Randomization: There will be no randomization in this study. Blinding/Breaking of Blinding: The study is open-label. There will be no blinding.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Descriptive phase I clinical study, open-label, multicenter, non-randomized, uncontrolled.
| Arm | Type | Receives |
|---|---|---|
| Group 1- 25 μg dose | Experimental | Biological: Grupo 1 - dose 25 μgGroup consisting of 30 participants (5 from the sentinel group + 25 participants). This group will receive the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 25 μg. |
| Group 2 - 50 μg dose | Experimental | Biological: Group 2 - 50 μg doseGroup consisting of 30 participants (5 from the sentinel group + 25 participants). This group will receive the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 50 μg. |
| Group 3 - 100 μg dose | Experimental | Biological: Group 3 - 100 μgGroup consisting of 30 participants (5 from the sentinel group + 25 participants). This group will receive the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 100 μg. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (36 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grupo 1 - dose 25 μgAdministration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 25 μg (single intramuscular dose) | Biological | Group 1- 25 μg dose |
| Group 2 - 50 μg doseAdministration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 50 μg (single intramuscular dose) | Biological | Group 2 - 50 μg dose |
| Group 3 - 100 μgAdministration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 100 μg (single intramuscular dose) | Biological | Group 3 - 100 μg dose |
Primary outcome
Safety outcomes following experimental vaccination
Time frame: Up to 7 days after vaccination.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
10 secondary outcomes
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 28, 90, and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7, 28, 90 and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7, 28, 90, and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7, 28, 90, and 180 days after vaccination.
Assessment of cellular and humoral safety and immunity.
Time frame: Reported at 7, 28, 90, and 180 days after vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria de Lourdes de Sousa Maia, Physician study director
Oswaldo Cruz Foundation/Bio-Manguinhos Immunobiological Institute
Marcellus Dias da Costa, Infectious disease physician principal investigator
Evandro Chagas National Institute of Infectious Diseases
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Grupo 1 - dose 25 μg, Group 2 - 50 μg dose and Group 3 - 100 μg in people with Severe Acute Respiratory Syndrome (SARS-CoV-2 Virus), run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Cerbino Neto, Infectious disease physician (+55 (21) 99967-1880, cerbino.neto@fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcomes following experimental vaccination (time frame: Up to 7 days after vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.