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

NCT ID: NCT05630313

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2023-09-30

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).

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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;

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oswaldo Cruz Foundation

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrícia de Oliveira, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Fernandes Figueira

Locations

Unidade de Ensaios Clínicos para Imunobiológicos (UECI)

Rio de Janeiro, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Patrícia de Oliveira, MD

Role: CONTACT

patricia.mouta@bio.fiocruz.br

+55213882-2013

Facility Contacts

Patrícia de Oliveira, MD

Role: primary

patricia.mouta@bio.fiocruz.br

+55213882-2013

Other Identifiers

ASCLIN 001/2022

Identifier Type: -

Identifier Source: org_study_id