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Hepatitis A Vaccination in the Elderly

This study is currently recruiting participants.
Verified June 2011 by Rijnstate Hospital
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01353989
First received: June 21, 2010
Last updated: June 3, 2011
Last verified: June 2011
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

5 times 7 ml of blood will be collected


Estimated Enrollment: 120
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)
Groups/Cohorts
>60 years
< 40 years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353989

Contacts
Contact: Jet Gisolf, MD jgisolf@alysis.nl

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Netherlands
Contact: Jet Gisolf, MD     088-0055944     jgisolf@alysis.nl    
Principal Investigator: Jet Gisolf, MD, PhD            
Sponsors and Collaborators
Rijnstate Hospital
  More Information

No publications provided

Responsible Party: dr EH Gisolf, Rijnstate Hospital, Arnhem, the Netherlands
ClinicalTrials.gov Identifier: NCT01353989     History of Changes
Other Study ID Numbers: Hepatitis A vaccination
Study First Received: June 21, 2010
Last Updated: June 3, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on May 23, 2013