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临床试验/NCT04416477
NCT04416477Unknown不适用

Duration of Immunity 10 Years After a Dose-response Study With Yellow Fever Vaccine - Complementary Study

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2019年4月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
255
试验地点
1
主要终点
Number of individuals who were protected 10 years after the first dose of the yellow fever vaccine, assessed by the neutralization test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Have participated as a volunteer of the study carried out in
  • Seronegative volunteers before vaccination in the study "Dose-response study of yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz" carried out in
  • Non-revaccinated volunteers, seropositive in the study "Duration of immunity to yellow fever in volunteers eight years after a dose-response study", conducted in
  • 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
  • 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.

排除标准

  • Refusal to collect biological material (blood).

结局指标

主要结局

Number of individuals who were protected 10 years after the first dose of the yellow fever vaccine, assessed by the neutralization test

时间窗: 10 years after the first dose of yellow fever vaccine

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.

次要结局

未报告次要终点

研究者

发起方
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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