Hepatitis A Vaccination in the Elderly
Recruitment status was Recruiting
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.
|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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
5 times 7 ml of blood will be collected
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|< 40 years|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353989
|Contact: Jet Gisolf, MDfirstname.lastname@example.org|
|Contact: Jet Gisolf, MD 088-0055944 email@example.com|
|Principal Investigator: Jet Gisolf, MD, PhD|