Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers

NCT03938597 | Unknown DMC

• 1 other identifier: ASCLIN002/2016
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug-Related Side Effects and Adverse Reactions

Keywords

yellow fever vaccine; genetic factors; viscerotropic disease; neurological disease

Outcome Measures

Primary Outcomes (1)

• Genetic markers

  Whole exome sequencing (WES) will be performed in YEL-AVD cases.

  Time frame: 5 years

Eligibility Criteria

• Age: 9 Months - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit cases of severe adverse event after yellow fever vaccine.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Cases with adverse event after yellow fever vaccine not severe.

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead
• Rockefeller University: collaborator

Study Sites (1)

Assessoria Clinica / Bio-Manguinhos / Fiocruz

Rio de Janeiro, Rio de Janeiro, 21.040-360, Brazil

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Nervous System Diseases

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Central Study Contacts

Patricia MN de Oliveira, MD, PhD

CONTACT

552138827000; patricia.mouta@bio.fiocruz.br

Jean-Laurent Casanova, PhD

CONTACT

+1 212 3277332; casanova_studies@rockefeller.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 6, 2019
• Study Start: January 30, 2017
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)