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

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).

Study Overview

• Status: Recruiting
• Conditions: Guillain-Barre Syndrome; Transverse Myelitis; Acute Disseminated Encephalomyelitis; Vaccine-induced Thrombotic Thrombocytopenia Syndrome

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Patrícia de Oliveira, MD; Phone Number: +55213882-2013; Email: patricia.mouta@bio.fiocruz.br

Study Locations

• Brazil
  • Rio De Janeiro, Brazil
    • Recruiting
    • Unidade de Ensaios Clínicos para Imunobiológicos (UECI)
    • Contact: Patrícia de Oliveira, MD; Phone Number: +55213882-2013; Email: patricia.mouta@bio.fiocruz.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 classified in causality categories (PNI/MS) as A2, A3, A4, C or D;
• Refusal to sign the informed consent form;

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Collaborators: Oswaldo Cruz Foundation
• Investigators: Principal Investigator: Patrícia de Oliveira, MD, Instituto Fernandes Figueira

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Transverse Myelitis; Covid-19 vaccine; Acute Disseminated Encephalomyelitis; Guillain-Barre Syndrome; Vaccine-induced thrombotic thrombocytopenia; Seriuos Adverse Events
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Immune System Diseases; Neoplasms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neoplasms by Site; Disease Attributes; Disease; Hematologic Diseases; Neuromuscular Diseases; Central Nervous System Infections; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Spinal Cord Diseases; Nervous System Neoplasms; Blood Platelet Disorders; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Leukoencephalopathies; Polyradiculoneuropathy; Polyneuropathies; Chronic Disease; Neuroinflammatory Diseases; Post-Infectious Disorders; Syndrome; Thrombocytopenia; Guillain-Barre Syndrome; Myelitis; Myelitis, Transverse; Encephalomyelitis; Encephalomyelitis, Acute Disseminated
• Other Study ID Numbers: ASCLIN 001/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No