Hepatitis A Vaccination in the Elderly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Rijnstate Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01353989
First received: June 21, 2010
Last updated: June 3, 2011
Last verified: June 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014