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临床试验/NCT04638335
NCT04638335已完成不适用

Study to Determine the Proportion of Travelers Over the Age of 60 Years and Travelers Having Lived in a Tropical Country for More Than 5 Years With Anti-HAV Antibodies

University of Lausanne Hospitals1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
the percentage of anti-HAV positive tests in the two groups will be calculated

研究概览

简要总结

Study to determine the proportion of travelers over the age of 60 years and travelers having lived in a tropical country for more than 5 years with anti-HAV antibodies. This will be done through a blood test. The investigators will then proceed with a short statistical analysis.

详细描述

Introduction:

Hepatitis A is an infection which is found internationally but mainly in areas where hygiene standards aren't high, as it is transmitted via the fecal-oral route. It is found mainly in Asia, Africa and South America. In these areas, it is mainly children who are infected. The seroprevalence rate reaches close to 100% at 5 years of age in some of these areas. To prevent transmission, following the hygiene recommendations and getting vaccinated are important.

In Switzerland, an average of 60 cases are recorded yearly. These cases are mainly brought in from travelers in countries where hepatitis A is prevalent. Despite this, the prevalence of hepatitis A in Switzerland has diminished over the years. A 1990 study done in Switzerland that measured seroprevalence in different age groups, concluded that it was useful to do a pre-immunisation test in travelers born before 1944 (age 46, now age 75, about a 50% seroprevalence rate), had a history of jaundice or had a prolonged stay (>1 year) in the tropics, subtropics or in Southern Europe. The FOPH (Federal office of public health) has therefore adjusted the vaccination plan to aligne with this conclusion.

Despite the FOPH recommendations, the Expert Committee of Travel Medicine in Switzerland has agreed upon that people who have lived in tropical countries (outside of Europe or North America) for more than 5 years and people who are older than 65 years of age have already developed an immunity against hepatitis A, either through a symptomatic or asymptomatic infection in their infancy. Therefore, they are not vaccinated and their serology isn't tested. The validity of this claim is questionable. Firstly, the level of hygiene has improved in many countries including Switzerland since 1990 when the latest study was done. Secondly, the seroprevalence rate has decreased from 1975 to 2014 in the European Economic Area and European Union. Conversely, the proportion of susceptible people has increased. Thirdly, there is very little circulation of the virus in Switzerland and that has been the case since at least 1988 so there is less of a likelihood that people have gotten infected with the virus. Lastly, In Asia, Latin America, Eastern Europe and the middle East the level of endemicity has decreased over the years due to improved hygienic conditions. Consequently, people that have lived in these countries for 5 years may not have been infected by the virus.

The primary objective is to determine the seroprevalence of anti-HAV in those two groups. The two groups will be analysed separately. If the seroprevalence is >90%, then no vaccination or serology test should be taken. If it is between 50% and 90%, then a serology test should be done first before potentially vaccinating. If it is below 50% then the traveler should be vaccinated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • people over 60 years old or travelers that have lived in a tropical country for at least 5 years who consult the travel clinic of Unisanté

排除标准

  • subjects who have not given their consent,
  • are younger than 5 years old,
  • are unable to participate for some reason,
  • have already been vaccinated against hepatitis A
  • have been injected with immunoglobulins in the past 2 months (half-life of GamaStan: 23 days)

结局指标

主要结局

the percentage of anti-HAV positive tests in the two groups will be calculated

时间窗: through study completion, an average of 1 year

In the first groupe, the percentage of travelers over 60 years of age with a positive anti-HAV test will be calculated. In the second groupe, the percentage of travelers having lived for more than 5 years in a tropical country with a positive anti-HAV test will be calculated.

次要结局

未报告次要终点

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serge de Valliere

Principal Investigator

University of Lausanne Hospitals

研究点 (1)

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