Hepatitis AAHAVNCT04638335
What is the Anti-HAV Seroprevalence of Travelers >60 Years or Having Lived in a Tropical Country for >5 Years
An observational study of Hepatitis A, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Blood test
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Oct 2019to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: travelers coming for a consultation at the Policlinique de Médecine Tropicale, voyages et vaccinations, Unisanté
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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
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.
Read the detailed description
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.
Method:
This is a cross-sectional mono centric national observational study. The inclusion criteria are 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.
The exclusion criteria are if the patient has not consented or is unable to, if they have already been vaccinated against hepatitis A and if they have been injected with immunoglobulines in the past 2 months (half-life of GamaStan: 23 days).
For each participant that has agreed to take part in this project, serum will be drawn. The serum will then be sent to the laboratoire de diagnostic of the CHUV. The results will then be inserted in the patient's case report form. Once about 200 patients (100 for each group) have been collected, a percentage of seroprevalence for each groupe will be determined.
Expected output:
Through this study, the investigators will have a better idea of the seroprevalence in the two groups who are potentially at risk of being infected by Hepatitis A and who are not receiving any preventative measures. The investigators expect that the seroprevalence rate in the two groups will be lower than 90% and therefore the standard of care will need to be changed.
- Conditions
- Hepatitis A
- Being tested
- Blood test
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
blood test for Anti-HAV antibodies
| Study group | Role | What they receive |
|---|---|---|
| travelers over the age of 60 | blood sample taken to test the presence of Anti-HAV antibodies Receives: Biological: Blood test | |
| travelers having lived in a tropical country for more than 5 years | blood sample taken to test the presence of Anti-HAV antibodies Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of anti-HAV positive tests in the two groups will be calculated
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start6 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge de Valliere, University of Lausanne Hospitals
- Investigators
- Serge De vallière, MD,MSc, Principal investigator, Unisanté
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638335
- Sponsor's protocol ID
- AHAV-UNIL
- Acronym
- AHAV
- Status last verified
- Aug 2022
- First submitted
- 25 Oct 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymized data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04638335
- Acronym / sponsor ID
- AHAV / AHAV-UNIL
- Conditions
- Hepatitis A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 6 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Method:
This is a cross-sectional mono centric national observational study. The inclusion criteria are 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.
The exclusion criteria are if the patient has not consented or is unable to, if they have already been vaccinated against hepatitis A and if they have been injected with immunoglobulines in the past 2 months (half-life of GamaStan: 23 days).
For each participant that has agreed to take part in this project, serum will be drawn. The serum will then be sent to the laboratoire de diagnostic of the CHUV. The results will then be inserted in the patient's case report form. Once about 200 patients (100 for each group) have been collected, a percentage of seroprevalence for each groupe will be determined.
Expected output:
Through this study, the investigators will have a better idea of the seroprevalence in the two groups who are potentially at risk of being infected by Hepatitis A and who are not receiving any preventative measures. The investigators expect that the seroprevalence rate in the two groups will be lower than 90% and therefore the standard of care will need to be changed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| travelers over the age of 60 | – | Biological: Blood testblood sample taken to test the presence of Anti-HAV antibodies |
| travelers having lived in a tropical country for more than 5 years | – | Biological: Blood testblood sample taken to test the presence of Anti-HAV antibodies |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- travelers coming for a consultation at the Policlinique de Médecine Tropicale, voyages et vaccinations, Unisanté
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testblood test for Anti-HAV antibodies | Biological | travelers having lived in a tropical country for more than 5 years, travelers over the age of 60 |
Primary outcome
the percentage of anti-HAV positive tests in the two groups will be calculated
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Yes. All anonymized data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge De vallière, MD,MSc principal investigator
Unisanté
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis A, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of anti-HAV positive tests in the two groups will be calculated (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.