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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
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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 South America Central America and Africa. In cities the yellow fever vector is the Aedes aegypti mosquito which also transmits dengue viruses zika and chikungunya. This disease is more frequent in males and the most affected age group is above fifteen years due to the greater exposure related to the penetration in wild areas of the endemic zone of yellow fever. Another risk group is unvaccinated people who live near wild environments where the virus circulates. According to the World Health Organization a single dose of the yellow fever vaccine is sufficient to maintain protective immunity against yellow fever for a lifetime therefore a booster dose is not required. This question is difficult to evaluate because there is no serological correlate of protection against yellow fever and seropositivity is defined with several cut off points. Although studies indicate that the duration of protection after vaccination is long there is considerable evidence in the literature that antibody titer falls over the years reaching levels considered as seronegative in at least a portion of the vaccinees. This is of more concern to people living in endemic areas who are exposed to the virus throughout their lives. For this reason Brazil recommended revaccinating once at least until additional studies were done. The need to increase Bio Manguinhos production capacity to meet the increased demand from Brazil and other countries is urgent. The occurrence of epidemics when millions of individuals need to be vaccinated in a short period of time exceeds production capacity and this is a recurrent problem. The current vaccine has a very high potency well above the thousand international units recommended by World Health Organization. But we need to generate additional evidence that very low doses of viral particles in the yellow fever vaccine are still immunogenic and that their immunogenicity can be maintained for at least ten years after vaccination. This evidence will support the rapid increase of their availability by the fractionation of doses or other alternatives.
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 Bio Manguinhos Fiocruz. The purpose of this study is to know whether reduced dose immunity is maintained for at least ten years. This information is crucial to support the recommendation to use fractional dose in adults a topic of great interest to World Health Organization.
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| 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 | 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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Inclusion Criteria:
Note: Individuals with a history of travel to areas endemic for yellow fever may be included but will be analyzed separately.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akira Homma | Contact | +55 (21) 3882-9479 | Akira@bio.fiocruz.br | |
| Maria de Lourdes de Sousa Maia | Contact | +55 (21) 3882-9474 | lourdes.maia@bio.fiocruz.br |
| Name | Affiliation | Role |
|---|---|---|
| Akira Homma | Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos / FIOCRUZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Ensaios ClÃnicos em Imunobiológicos / Instituto de Tecnologia em Imunobiológicos de Bio-Manguinhos / Fiocruz | Recruiting | Rio de Janeiro | Rio de Janeiro | 21040-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38926068 | Derived | Vianna CM, Noronha TG, Camacho LAB, Andrade RC, de Souza Brum RC, Dos Santos EM, Aguiar DF, Dos Santos MLB, de Souza Cruz RL, de Lima SMB, de Souza Azevedo Soares A, Schwarcz WD, da Matta de Castro T, Xavier JR, da Conceicao DA, Homma A, de Lourdes de Sousa Maia M. Duration of post-vaccination immunity to yellow fever in volunteers ten years after a dose-response study - A complementary study. Vaccine. 2024 Oct 24;42(24):126083. doi: 10.1016/j.vaccine.2024.06.050. Epub 2024 Jun 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 29, 2022 | |
| Reset | Oct 24, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 29, 2022 | Oct 24, 2023 |
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A volume of up to 10 mL of whole blood should be collected without anticoagulant. There will be at most two attempts at blood collection per participant.
The study samples will be aliquoted and after will be stored for a maximum of 10 years in the biorepository of the Institute of Technology in Immunobiologicals (Bio-Manguinhos), Fiocruz, Rio de Janeiro, Brazil, and this time will begin at the end of the last participant's collection.
An additional written Informed Consent Form will assess whether the participant wishes to donate part of the samples to Bio-Manguinhos BioBank. In this case, the biological sample shall be stored for an indeterminate period.
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