UnknownNot Applicable

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

Brazil100 participantsStarted 2022-10-04

Plain-language 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).

Who can participate

Age range

5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Sign the ICF by the subject or the subject's legally acceptable representative; * Sign the ICF by the participant's family member; * Proven vaccination with one of the vaccines for COVID-19 available by the PNI, containing information on the date of application, type (manufacturer) of vaccine received and batch (desirable); * Meet the minimum criteria for a level of certainty 3, 2 or 1 in Brighton Collaboration for vaccine-induced immune thrombotic thrombocytopenia as described in 3.2.1.1 OR, * Meet the minimum criteria for a level of certainty 3, 2 or 1 in Brighton Collaboration for Guillain-Barré syndrome as described in 3.2.1.3 OR, * Meet the minimum criteria for a level of certainty 3, 2 or 1 in Brighton Collaboration for Acute Disseminated Encephalomyelitis as described in 3.2.1.4 OR, * Meet the minimum criteria for a level of certainty 3, 2 or 1 in Brighton Collaboration for Transverse Myelitis as described in 3.2.1.5 OR, * Be classified in the causality categories adopted by the PNI/MS, namely: A1, B1 or B2. Exclusion Criteria: * Reports in which it is not possible to retrieve the clinical/laboratory data necessary for evaluation, due to inadequate filling of the notification or unavailability of data; * Cases of death in which there are no samples available and/or suitable for carrying out the analyzes defined in the protocol; * Cases in which another diagnosis is made for the adverse event of interest, being discarded as a SAE; * Cases classi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Genomic evaluation

Timeframe: March, 2023.

Trial details

NCT IDNCT05630313

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-30

Contact for this trial

Patrícia de Oliveira, MD

+55213882-2013 patricia.mouta@bio.fiocruz.br

View on ClinicalTrials.gov More Vaccine-induced Thrombotic Thrombocytopenia Syndrome trials