An observational study in Drug-Related Side Effects and Adverse Reactions, sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz). Recruiting at 1 site in Brazil. Open to participants aged 9 Months to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Observational
It concerns an investigation aiming to investigate genetic biological(s) marker(s) which allow to identify individuals who have risk of serious adverse events to the yellow fever vaccine. This testing is free of hypothesis, because these markers are still unknown. There is no intervention, and it is not possible to establish primary and secondary outcomes.
The rational for the immunological study by LATIM is the observation made by the group that individuals vaccinated with the 17DD yellow fever vaccine show significant alterations on the levels of expression of genes such as CLEC5A, IFNG, IL6, RNASEL, IRF7, IRF9, STAT2 e OAS1 (8). The study which will be conducted by the Rockefeller University will be focused in the qualitative analysis of the genome and exome of volunteers. The study in LATIM will be focused in the quantitative analysis of mRNA, which, together with the results of sequencing, may help in the search for biomarkers. As the expression of mRNA is restricted to the acute phase of the adverse event, it will be done only during the first 30 days after the beginning of the adverse event.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's planned enrollment of 10 is below the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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This study will recruit cases of severe adverse event after yellow fever vaccine.
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Positive culture for more than 7 days after vaccination; RT-PCR ≥ 3 log10 PFU/mL at any day after vaccination; Positive RT-PCR more than 14 days after vaccination; Presence of vaccine virus in tissue by culture, RT-PCR or immunohistochemistry.
Exclusion Criteria:
Genetic markers
Whole exome sequencing (WES) will be performed in YEL-AVD cases.
Time frame: Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2017 (actual). Primary completion is estimated for Jun 2023, 77 months after the start.
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Drug-Related Side Effects and Adverse Reactions →
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)