Drug-Related Side Effects and Adverse Reactions Clinical Trial
Official title:
Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Months to 59 Years |
Eligibility | Inclusion criteria: - Evidence of a systemic reaction in two or more organs within one month of vaccination with yellow fever vaccine; - Laboratory evidence of yellow fever vaccine virus (at least one): 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. - Laboratory exclusion of relevant differential diagnosis such as leptospirosis, viral hepatitis and arboviruses. - Cases not obeying these strict criteria but that could be plausibly YEL-AVD or YEL-AND may be included, if approved by the investigator or co-investigators. Exclusion Criteria: - Cases with adverse event after yellow fever vaccine not severe. |
Country | Name | City | State |
---|---|---|---|
Brazil | Assessoria Clinica / Bio-Manguinhos / Fiocruz | Rio De Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) | Rockefeller University |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Genetic markers | Whole exome sequencing (WES) will be performed in YEL-AVD cases. | Time frame: 5 years |
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