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Hepatitis A Vaccination in the Elderly

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ClinicalTrials.gov Identifier: NCT01353989
Recruitment Status : Completed
First Posted : May 16, 2011
Last Update Posted : June 28, 2016
Sponsor:
Information provided by:
Rijnstate Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

A lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A IgG positivity is declining in the Netherlands, also in the elderly. Studies show that people above 40 years of age have a slower immune response to hepatitis A vaccination. However, a lot of travelers seek pre-travel advice only shortly before their journey. More information about the time to adequate antibody response after hepatitis A vaccination is required to provide good protection during travelling. Alternative protection with immunoglobulins are available.

Study design: Observational, longitudinal pilot study Study population: 20 adults over 60 years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as controls.

Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28.

Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: hepatitis A vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml of blood.


Condition or disease
Hepatitis A

Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hepatitis A Vaccination in the Elderly
Study Start Date : July 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
>60 years
< 40 years


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. How fast do patients> 60 year reach protective anti-HAV levels after vaccination? [ Time Frame: 0, 1,2,3,4 weeks ]

Biospecimen Retention:   Samples With DNA
5 times 7 ml of blood will be collected

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
80 >60 years, hepatitis A vaccination indicated 40 < 40 years, hepatitis A vaccination indicated
Criteria

Exclusion Criteria:

  • previous hep A vaccination
  • known hepatitis A serology status
  • immunodeficiency
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353989


Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: dr EH Gisolf, Rijnstate Hospital, Arnhem, the Netherlands
ClinicalTrials.gov Identifier: NCT01353989     History of Changes
Other Study ID Numbers: Hepatitis A vaccination
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Rijnstate Hospital:
hepatitis A
vaccination
elderly
protection to hepatitis A after vaccination

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs