Vaccine-induced Thrombotic Thrombocytopenia SyndromeNCT05630313
Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil
An observational study of Vaccine-induced Thrombotic Thrombocytopenia Syndrome and Guillain-Barre Syndrome, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine-induced Thrombotic Thrombocytopenia Syndrome, Guillain-Barre Syndrome, Acute Disseminated Encephalomyelitis
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Oct 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Unidade de Ensaios Clínicos para Imunobiológicos (UECI)
Rio de Janeiro
Patrícia de Oliveira, MD, +55213882-2013, patricia.mouta@bio.fiocruz.br
About this study
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).
Read the 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
- Keywords
- Vaccine-induced thrombotic thrombocytopenia, Guillain-Barre Syndrome, Acute Disseminated Encephalomyelitis, Transverse Myelitis, Covid-19 vaccine, Seriuos Adverse Events
- Medical subject headings
- Guillain-Barre Syndrome, Encephalomyelitis, Acute Disseminated, Myelitis, Transverse
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic evaluation
Identify if any genetic marker is envolved in the serious adverse event pathogenesis induced by covid-19 vaccination.
Measured: March, 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start4 Oct 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine-induced Thrombotic Thrombocytopenia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Responsible party
- Sponsor
- Investigators
- Patrícia de Oliveira, MD, Principal investigator, Instituto Fernandes Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630313
- Sponsor's protocol ID
- ASCLIN 001/2022
- Status last verified
- Jun 2023
- First submitted
- 23 Nov 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil
- ClinicalTrials.gov ID
- NCT05630313
- Acronym / sponsor ID
- ASCLIN 001/2022
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genomic evaluation
Time frame: March, 2023.
Identify if any genetic marker is envolved in the serious adverse event pathogenesis induced by covid-19 vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrícia de Oliveira, MD principal investigator
Instituto Fernandes Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine-induced Thrombotic Thrombocytopenia Syndrome and Guillain-Barre Syndrome, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrícia de Oliveira, MD (+55213882-2013, patricia.mouta@bio.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic evaluation (time frame: March, 2023.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.