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

NCT05630313 | Unknown

• 1 other identifier: ASCLIN 001/2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Vaccine-induced Thrombotic Thrombocytopenia Syndrome; Guillain-Barre Syndrome; Acute Disseminated Encephalomyelitis; Transverse Myelitis

Keywords

Vaccine-induced thrombotic thrombocytopenia; Guillain-Barre Syndrome; Acute Disseminated Encephalomyelitis; Transverse Myelitis; Covid-19 vaccine; Seriuos Adverse Events

Outcome Measures

Primary Outcomes (1)

• Genomic evaluation

  Identify if any genetic marker is envolved in the serious adverse event pathogenesis induced by covid-19 vaccination.

  March, 2023.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead
• Oswaldo Cruz Foundation: collaborator

Study Sites (1)

Unidade de Ensaios Clínicos para Imunobiológicos (UECI)

Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Guillain-Barre Syndrome; Encephalomyelitis, Acute Disseminated; Myelitis, Transverse

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases

Study Officials

• Patrícia de Oliveira, MD

  Instituto Fernandes Figueira

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrícia de Oliveira, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: November 29, 2022
• Study Start: October 4, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)