跳至主要内容
临床试验/NCT02572518
NCT02572518已完成不适用

Duration of Immunity After Two Doses of Vaccine Against Yellow Fever in Adults

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 440 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
440
试验地点
1
主要终点
Access the change of the immune status to yellow fever in adults history of two or more doses of vaccine, having received the second dose for at least one year, compared to revaccinated individuals (second dose) after 30 days.

研究概览

简要总结

To evaluate the immune status of yellow fever in adults with a history of two or more doses of vaccine, having received the second dose for at least 1 year, compared to re-vaccinated individuals (second dose) after 30 days.

详细描述

Data Collection Volunteers will be invited to participate by bringing card (s ) vaccination or copy ( s ) of record ( s ) in which it appears ( m) ( s ) dose ( s) received yellow fever vaccine ( s ) and ( s ) their ( s ) date ( s ) . Individuals who agree to participate in the study and signed an Informed Consent Form will be forwarded to interview and application of Inclusion Questionnaire , which will identify possible eligible for the study and classify them according to the time of vaccination. Then a medical review of the history of vaccination with the date or the age in which they occurred , the cities and the period in which he lived and the relevant pathological history , hospitalizations and treatment for chronic diseases will be taken , then proceeding to blood collection.

Upon completion of the subject's participation in the research study , registration must be done at the closing to participate in the study .A group of volunteers previously vaccinated with a dose of yellow fever vaccine and booster having the indicated activity in the areas in which the vaccine is recommended that , constitute a group of 110 patients with different to the search approach, in which a pickup is performed Whole blood for analysis of cellular immune 30-45 days after revaccination.

The clinical forms of the study will be prepared and processed in " TELEform " program , which will enable the digitization and preparation of database.

Sample Size Whereas 98% seropositivity and presence of cellular response after 30 days of revaccination as reference, 110 volunteers will be needed in each group to detect minute differences of 10 percentage points with 80% power and a significance level of 5%.

A total of 440 volunteers with 110 distributed in each group. Samples of 110 individuals will estimate proportions of seropositive up to 50% with precision of 9 percentage points for each side.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Will be eligible for the study volunteers with proof of vaccination in vaccine design or functional or health care records, and who agree to participate in the study.

排除标准

  • Will not be included adults with a contraindication for vaccination against Yellow Fever (permanent or transient immunosuppression, severe adverse reaction after the first dose, severe allergy to chicken eggs), use of hyperimmune serum or vaccine within 30 days prior to collection blood, individuals without proof (s) of vaccination (s) above (ies) or individuals who have resided or traveled to endemic or considered risk areas by the Ministry of Health, regardless of length of stay in high-risk areas.

结局指标

主要结局

Access the change of the immune status to yellow fever in adults history of two or more doses of vaccine, having received the second dose for at least one year, compared to revaccinated individuals (second dose) after 30 days.

时间窗: 30 days, 1-5 years, through study completion at least 6 years after second dose of yellow fever vaccine, with 3 doses at any age

次要结局

  • Access the cellular immunity(30 days, 1-5 years, through study completion at least 6 years after second dose of yellow fever vaccine, with 3 doses at any age)

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)

Loading locations...

相似试验