NCT07640308

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
17mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Jan 2028

First Submitted

Initial submission to the registry

March 17, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

March 17, 2026

Last Update Submit

June 8, 2026

Conditions

Severe Acute Respiratory Syndrome (SARS-CoV-2 Virus)

Keywords

mRNA PlatformCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Safety outcomes following experimental vaccination

    Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\].

    Up to 7 days after vaccination.

Secondary Outcomes (10)

  • Assessment of cellular and humoral safety and immunity.

    Reported at 28, 90, and 180 days after vaccination.

  • Assessment of cellular and humoral safety and immunity.

    Reported at 7, 28, 90 and 180 days after vaccination.

  • Assessment of cellular and humoral safety and immunity.

    Reported at 7, 28, 90 and 180 days after vaccination.

  • Assessment of cellular and humoral safety and immunity.

    Reported at 7, 28, 90 and 180 days after vaccination.

  • Assessment of cellular and humoral safety and immunity.

    Reported at 7, 28, 90 and 180 days after vaccination.

  • +5 more secondary outcomes

Study Arms (3)

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.

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.

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.

Biological: Group 3 - 100 μg

Interventions

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 1- 25 μg 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 2 - 50 μg 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)

Group 3 - 100 μg dose

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged between 18 and 59 years.
  • 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.

You may not qualify if:

  • 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.
  • History of multisystem inflammatory syndrome (MIS-C or MIS-A).
  • Previous diagnosis of immunodeficiency, autoimmune diseases, or cardiomyopathies.
  • History of malignant neoplasm in the 12 months prior to screening (V-1).
  • Uncontrolled coagulopathy or any hematological condition that contraindicates intramuscular injection.
  • 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.
  • Pregnancy or lactation at the time of visit V0, or planning to become pregnant during the study period.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Maria de Lourdes de Sousa Maia, Physician

    Oswaldo Cruz Foundation/Bio-Manguinhos Immunobiological Institute

    STUDY DIRECTOR

  • Marcellus Dias da Costa, Infectious disease physician

    Evandro Chagas National Institute of Infectious Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José Cerbino Neto, Infectious disease physician

CONTACT

+55 (21) 99967-1880cerbino.neto@fiocruz.br

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Descriptive phase I clinical study, open-label, multicenter, non-randomized, uncontrolled.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2026

First Posted

June 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

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