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Bio-Manguinhos/Fiocruz COVID-19 (mRNA) Vaccine Booster

NCT07640308 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

Grupo 1 - dose 25 μg

Administration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 25 μg (single intramuscular dose)

BIOLOGICAL

Group 2 - 50 μg dose

Administration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 50 μg (single intramuscular dose)

BIOLOGICAL

Group 3 - 100 μg

Administration of the experimental COVID-19 vaccine (mRNA) - Bio-Manguinhos/Fiocruz - at a dose of 100 μg (single intramuscular dose)

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

    lead OTHER

Principal Investigators

  • Maria de Lourdes de Sousa Maia, Physician · Oswaldo Cruz Foundation/Bio-Manguinhos Immunobiological Institute

  • Marcellus Dias da Costa, Infectious disease physician · Evandro Chagas National Institute of Infectious Diseases

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2028-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640308 on ClinicalTrials.gov