Trials / Unknown
UnknownNCT05630313
Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Academic / Other
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Accepted
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).
Detailed 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.
Conditions
- Vaccine-induced Thrombotic Thrombocytopenia Syndrome
- Guillain-Barre Syndrome
- Acute Disseminated Encephalomyelitis
- Transverse Myelitis
Timeline
- Start date
- 2022-10-04
- Primary completion
- 2023-09-30
- Completion
- 2023-09-30
- First posted
- 2022-11-29
- Last updated
- 2023-06-13
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05630313. Inclusion in this directory is not an endorsement.