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| Name | Class |
|---|---|
| Oswaldo Cruz Foundation | OTHER |
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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Genomic evaluation | Identify if any genetic marker is envolved in the serious adverse event pathogenesis induced by covid-19 vaccination. | March, 2023. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects more than 5 years to no limit maximum age, both sex, which have presented the protocol interest SAE (vaccine-induced immune thrombotic thrombocytopenia, Guillain-Barré syndrome, Acute Disseminated Encephalomyelitis, Transverse Myelitis) can be arrolled. First-degree relatives, primarily parents and/or siblings, will have biological samples collected and stored to be used for future genomic sequencing, if genetic alterations are identified in their relatives who had SAE.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PatrĂcia de Oliveira, MD | Contact | +55213882-2013 | patricia.mouta@bio.fiocruz.br |
| Name | Affiliation | Role |
|---|---|---|
| PatrĂcia de Oliveira, MD | Instituto Fernandes Figueira | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Ensaios ClĂnicos para ImunobiolĂ³gicos (UECI) | Recruiting | Rio de Janeiro | Brazil |
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| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| D004673 | Encephalomyelitis, Acute Disseminated |
| D009188 | Myelitis, Transverse |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D056784 | Leukoencephalopathies |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D013118 | Spinal Cord Diseases |
| D019636 | Neurodegenerative Diseases |
| D000090862 | Neuroinflammatory Diseases |
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