An observational study in Vaccine-induced Thrombotic Thrombocytopenia Syndrome, Guillain-Barre Syndrome and Acute Disseminated Encephalomyelitis, sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz). Recruiting at 1 site in Brazil. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Observational
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.
96 studies on the registry are indexed under Guillain-Barre Syndrome; 28 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 47 observational studies indexed under Guillain-Barre Syndrome.
Browse Guillain-Barre Syndrome studies →The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genomic evaluation
Identify if any genetic marker is envolved in the serious adverse event pathogenesis induced by covid-19 vaccination.
Time frame: March, 2023.
Plan to share: No
No publications or documents are linked to this record.
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The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)