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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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

Clinicaltrials.gov identifier NCT03938597

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted May 13, 2019

Study Description

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
  • Intervention/Treatment:
  • Phase: N/A
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.

Study Design
  • 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 2017
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: January 2022
Outcome Measures
  • Primary Outcome Measures: 1. Genetic markers [ Time Frame: Time frame: 5 years ]
    Whole exome sequencing (WES) will be performed in YEL-AVD cases.
Eligibility Criteria
  • Ages Eligible for Study: 9 to 59 Months (Child)
  • 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.

Contacts and Locations
Contacts

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

Brazil, RJ
Assessoria Clinica / Bio-Manguinhos / Fiocruz
Rio De Janeiro

Sponsors and Collaborators

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Rockefeller University

More Information
  • 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
  • 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
    viscerotropic disease
    neurological disease
    genetic factors
  • Additional relevant MeSH terms: Yellow Fever Drug-Related Side Effects and Adverse Reactions