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Hepatitis A Vaccination in the Elderly

Sponsor
Rijnstate Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01353989
Collaborator
(none)
60
Enrollment
1
Location
60
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Hepatitis A Vaccination in the Elderly
    Study Start Date :
    Jul 1, 2010
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Jul 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    >60 years
    < 40 years

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Exclusion Criteria:

    • previous hep A vaccination

    • known hepatitis A serology status

    • immunodeficiency

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rijnstate Hospital Arnhem Netherlands

    Sponsors and Collaborators

    • Rijnstate Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01353989
    Other Study ID Numbers:
    • Hepatitis A vaccination
    First Posted:
    May 16, 2011
    Last Update Posted:
    Jun 28, 2016
    Last Verified:
    Jun 1, 2016
    Keywords provided by , ,
    hepatitis A
    vaccination
    elderly
    protection to hepatitis A after vaccination
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis

    Study Results

    No Results Posted as of Jun 28, 2016