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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)

Tracking Information
First Submitted Date April 5, 2018
First Posted Date May 6, 2019
Last Update Posted Date May 13, 2019
Actual Study Start Date January 30, 2017
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019)
Genetic markers [ Time Frame: Time frame: 5 years ]
Whole exome sequencing (WES) will be performed in YEL-AVD cases.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03938597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
Official Title Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will recruit cases of severe adverse event after yellow fever vaccine.
Condition Drug-Related Side Effects and Adverse Reactions
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 2, 2019)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2022
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 9 Months to 59 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
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
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03938597
Other Study ID Numbers ASCLIN002/2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study Sponsor The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators Rockefeller University
Investigators Not Provided
PRS Account The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Verification Date May 2019