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

Guillain-Barre Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630313
• Other study ID #: ASCLIN 001/2022
• Status: Recruiting
• Start date: October 4, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Contact: Patrícia de Oliveira, MD
• Phone: +55213882-2013
• Email: patricia.mouta[@]bio.fiocruz.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Disseminated Encephalomyelitis
• Encephalomyelitis
• Guillain-Barre Syndrome
• Myelitis
• Myelitis, Transverse
• Syndrome
• Thrombocytopenia
• Transverse Myelitis

Locations

Country	Name	City	State
Brazil	Unidade de Ensaios Clínicos para Imunobiológicos (UECI)	Rio De Janeiro

Sponsors (2)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic evaluation	Identify if any genetic marker is envolved in the serious adverse event pathogenesis induced by covid-19 vaccination.	March, 2023.