Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil

Guillain-Barre Syndrome Clinical Trial

Official title: Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil

Status Recruiting

Clinical Trial Summary

This protocol proposes to investigate genetic factors that may be involved in the pathogenesis of adverse events of interest with selected covid-19 vaccines: vaccine-induced immune thrombotic thrombocytopenia, and neurological adverse events, such as Guillain-Barré syndrome, acute disseminated encephalomyelitis and transverse myelitis, with the intention of identifying useful biomarkers in identifying people at higher risk, thus reducing the occurrence of these serious adverse events (SAE).

Clinical Trial Description

Participants higher than 5 years old with no maximum age limit and both sexes, who had a serious adverse event after vaccination against Covid-19, such as Guillain-Barré syndrome, vaccine-induced immune thrombotic thrombocytopenia, transverse myelitis and Acute disseminated encephalomyelitis. Parents, siblings and/or sons of cases with SAE will have biological samples collected and stored; depending on the result of the study, they may have their samples analyzed later. ;

Related Conditions & MeSH terms

• Acute Disseminated Encephalomyelitis
• Encephalomyelitis
• Guillain-Barre Syndrome
• Myelitis
• Myelitis, Transverse
• Syndrome
• Thrombocytopenia
• Transverse Myelitis

• NCT number: NCT05630313
• Study type: Observational
• Source: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Contact: Patrícia de Oliveira, MD
• Phone: +55213882-2013
• Email: patricia.mouta@bio.fiocruz.br
• Status: Recruiting
• Start date: October 4, 2022
• Completion date: September 30, 2023