Investigation of genetic markers for serious adverse events after yellow fever vaccination
Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
This study is trying to find genetic markers that could help identify people at risk for serious side effects after getting the yellow fever vaccine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 9 Months to 59 Years |
| Sex | All |
| Sponsor | The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) Academic / other |
| Locations | 1 site (Rio De Janeiro, RJ) |
| Trial ID | NCT03938597 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify genetic biological markers that may indicate individuals at risk for serious adverse events following vaccination with the yellow fever vaccine. The research will involve qualitative analysis of the genome and exome of volunteers, alongside quantitative analysis of mRNA expression during the acute phase of adverse events. The study is free of hypothesis, focusing on discovering unknown markers related to drug-related side effects and adverse reactions. It will be conducted by the Rockefeller University and the Immunobiological Technology Institute.
Who should consider this trial
Good fit: Ideal candidates include individuals who have experienced systemic reactions in multiple organs within one month of receiving the yellow fever vaccine.
Not a fit: Patients who have experienced mild adverse events after yellow fever vaccination are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification of individuals at risk for severe reactions to the yellow fever vaccine, enhancing patient safety.
How similar studies have performed: While this study explores a novel approach to identifying genetic markers for vaccine-related adverse events, similar studies have shown promise in understanding genetic predispositions to vaccine reactions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rio De Janeiro, RJ
- Assessoria Clinica / Bio-Manguinhos / Fiocruz — Rio De Janeiro, Rj, Brazil (Recruiting)
Study contacts
- Study coordinator: Patricia MN de Oliveira, MD, PhD
- Email: patricia.mouta@bio.fiocruz.br
- Phone: 552138827000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.