Hepatitis A Vaccination in the Elderly

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01353989

Enrollment

Registered

2011-05-16

Start date

2010-07-31

Completion date

2015-07-31

Last updated

2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis A

Keywords

hepatitis A, vaccination, elderly, protection to hepatitis A after vaccination

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Exclusion criteria

* previous hep A vaccination * known hepatitis A serology status * immunodeficiency

Design outcomes

Primary

Measure	Time frame
How fast do patients> 60 year reach protective anti-HAV levels after vaccination?	0, 1,2,3,4 weeks

Countries

Netherlands

Outcome results