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Hepatitis A Vaccination in the Elderly

Completed
Conditions
Hepatitis A
Registration Number
NCT01353989
Lead Sponsor
Rijnstate Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria
  • previous hep A vaccination
  • known hepatitis A serology status
  • immunodeficiency

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
How fast do patients> 60 year reach protective anti-HAV levels after vaccination?0, 1,2,3,4 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rijnstate Hospital

🇳🇱

Arnhem, Netherlands

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