Status:
UNKNOWN
Duration of Immunity 10 Years After a Dose-response Study With Yellow Fever Vaccine - Complementary Study
Lead Sponsor:
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborating Sponsors:
Wellcome Trust
Conditions:
Yellow Fever Vaccine
Eligibility:
MALE
18+ years
Brief Summary
Yellow fever is an acute febrile infectious disease transmitted to man urban cycle by mosquitoes infected by an arbovirus of the genus Flavivirus family Flaviviridae. Its occurrence is recorded in Sou...
Detailed Description
This is an observational study in young adult males who received the first dose of the yellow fever vaccine when they participated in the Dose response study of the yellow fever vaccine produced by Bi...
Eligibility Criteria
Inclusion
- Have participated as a volunteer of the study carried out in 2009.
- Seronegative volunteers before vaccination in the study "Dose-response study of yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz" carried out in 2009. Non-revaccinated volunteers, seropositive in the study "Duration of immunity to yellow fever in volunteers eight years after a dose-response study", conducted in 2017.
- Not having received another yellow fever vaccine after participating in the study "Dose-response study of the yellow fever vaccine produced by Bio-Manguinhos / Fiocruz" carried out in 2009 and the study "Duration of immunity to yellow fever in volunteers eight years after a dose-response study", conducted in 2017.
- Available to follow up during the field study period.
- Agree to give name, address, phone, and other contact information, if necessary.
- Agree to strictly follow the study protocol.
- Able to understand and sign the Informed Consent Form (ICF).
- Understand the impossibility of participating in another clinical trial during the time of participation in this study.
- Note: Individuals with a history of travel to areas endemic for yellow fever may be included but will be analyzed separately.
Exclusion
- Refusal to collect biological material (blood).
Key Trial Info
Start Date :
April 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT04416477
Start Date
April 8 2019
End Date
August 31 2020
Last Update
June 4 2020
Active Locations (1)
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1
Unidade de Ensaios Clínicos em Imunobiológicos / Instituto de Tecnologia em Imunobiológicos de Bio-Manguinhos / Fiocruz
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-900