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

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ClinicalTrials.gov Identifier: NCT03938597
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Rockefeller University
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

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.

Condition or disease
Drug-Related Side Effects and Adverse Reactions

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever




Primary Outcome Measures :
  1. Genetic markers [ Time Frame: Time frame: 5 years ]
    Whole exome sequencing (WES) will be performed in YEL-AVD cases.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will recruit cases of severe adverse event after yellow fever vaccine.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938597


Contacts
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Contact: Emersom C Mesquita, MD, PhD 55 21 3882-7161 emersomcm@hotmail.com
Contact: Jean-Laurent Casanova, PhD +1 212 3277332 casanova_studies@rockefeller.edu

Locations
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Brazil
Assessoria Clinica / Bio-Manguinhos / Fiocruz Recruiting
Rio De Janeiro, RJ, Brazil, 21.040-360
Contact: Emersom C Mesquita, MD, PhD    55 21 38827161    emersomcm@hotmail.com   
Principal Investigator: Emersom C Mesquita, MD, PhD         
Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Rockefeller University

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Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT03938597     History of Changes
Other Study ID Numbers: ASCLIN002/2016
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):
yellow fever vaccine
genetic factors
viscerotropic disease
neurological disease

Additional relevant MeSH terms:
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Yellow Fever
Drug-Related Side Effects and Adverse Reactions
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Chemically-Induced Disorders