Hepatitis A Vaccination in the Elderly
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Purpose
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 |
|---|
| Hepatitis A |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Hepatitis A Vaccination in the Elderly |
- 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
| Enrollment: | 60 |
| Study Start Date: | July 2010 |
| Study Completion Date: | July 2015 |
| Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| >60 years |
| < 40 years |
Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Exclusion Criteria:
- previous hep A vaccination
- known hepatitis A serology status
- immunodeficiency
Contacts and Locations
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
| Netherlands | |
| Rijnstate Hospital | |
| Arnhem, Netherlands | |
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 Submitted: | June 21, 2010 |
| First Posted: | May 16, 2011 |
| 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 |