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Hepatitis A Vaccination in the Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353989
First Posted: May 16, 2011
Last Update Posted: June 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rijnstate Hospital
  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

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • 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

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

Information from the National Library of Medicine

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
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
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

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