Hepatitis A Vaccination in the Elderly
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
80 >60 years, hepatitis A vaccination indicated 40 < 40 years, hepatitis A vaccination indicated
Exclusion Criteria:
- previous hep A vaccination
- known hepatitis A serology status
- immunodeficiency
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01353989
| Contact: Jet Gisolf, MD | jgisolf@alysis.nl |
| Netherlands | |
| Rijnstate Hospital | Recruiting |
| Arnhem, Netherlands | |
| Contact: Jet Gisolf, MD 088-0055944 jgisolf@alysis.nl | |
| Principal Investigator: Jet Gisolf, MD, PhD | |
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 Digestive System Diseases Enterovirus Infections Hepatitis, Viral, Human |
Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015