Identifying genetic factors linked to serious vaccine side effects in Brazil

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

This study is trying to find out if certain genetic factors make some people more likely to have serious side effects from COVID-19 vaccines, focusing on those who have already experienced these issues.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 5 Years and up
• Sex: All
• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) (Academic / other)
• Locations: 1 site (Rio De Janeiro)
• Trial ID: NCT05630313 on ClinicalTrials.gov

What this trial studies

This study investigates the genetic factors that may contribute to serious adverse events following COVID-19 vaccinations, such as vaccine-induced thrombotic thrombocytopenia and neurological conditions like Guillain-Barré syndrome. Participants aged over 5 who have experienced these adverse events will have their biological samples collected for analysis. The goal is to identify biomarkers that can help predict which individuals are at higher risk for these serious complications, potentially leading to improved safety measures in vaccination programs.

Who should consider this trial

Good fit: Ideal candidates include individuals over 5 years old who have experienced serious adverse events after COVID-19 vaccination.

Not a fit: Patients who have not received a COVID-19 vaccine or have not experienced any serious adverse events related to vaccination may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better identification of individuals at risk for serious vaccine-related adverse events, enhancing vaccine safety.

How similar studies have performed: While this approach is novel in the context of COVID-19 vaccines, similar genetic investigations have shown promise in understanding adverse events related to other vaccines.

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;

Where this trial is running

Rio De Janeiro

• Unidade de Ensaios Clínicos para Imunobiológicos (UECI) — Rio De Janeiro, Brazil (Recruiting)

Study contacts

• Principal investigator: Patrícia de Oliveira, MD — Instituto Fernandes Figueira
• Study coordinator: Patrícia de Oliveira, MD

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