- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04416477
Duration of Immunity 10 Years After a Dose-response Study With Yellow Fever Vaccine - Complementary Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Akira Homma
- Phone Number: +55 (21) 3882-9479
- Email: Akira@bio.fiocruz.br
Study Contact Backup
- Name: Maria de Lourdes de Sousa Maia
- Phone Number: +55 (21) 3882-9474
- Email: lourdes.maia@bio.fiocruz.br
Study Locations
-
-
RJ
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Rio De Janeiro, RJ, Brazil, 21040-900
- Recruiting
- Unidade de Ensaios Clínicos em Imunobiológicos / Instituto de Tecnologia em Imunobiológicos de Bio-Manguinhos / Fiocruz
-
Contact:
- Akira Homma
- Phone Number: +55 (21) 3882-9479
- Email: Akira@bio.fiocruz.br
-
Contact:
- Maria de Lourdes de Sousa Maia
- Phone Number: +55 (21) 3882-9474
- Email: lourdes.maia@bio.fiocruz.br
-
Principal Investigator:
- Akira Homma
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Sub-Investigator:
- Maria de Lourdes de Sousa Maia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Participants will be healthy male adults who received the first dose of the yellow fever vaccine in 2009 when they participated in the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz".
Participation in the study will be documented at the time of signing the Informed Consent Form.
Description
Inclusion Criteria:
- 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 Criteria:
- Refusal to collect biological material (blood).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of individuals who were protected 10 years after the first dose of the yellow fever vaccine, assessed by the neutralization test
Time Frame: 10 years after the first dose of yellow fever vaccine
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Serological status of yellow fever in adult individuals 10 years after seroconversion in a low dose or full dose study of the 17DD yellow fever vaccine produced by Bio-Manguinhos / Fiocruz.
|
10 years after the first dose of yellow fever vaccine
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Akira Homma, Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos / FIOCRUZ
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASCLIN 001/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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