Hepatitis A Vaccination in the Elderly

NCT01353989 | Completed

• 1 other identifier: Hepatitis A vaccination
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis A

Keywords

hepatitis A; vaccination; elderly; protection to hepatitis A after vaccination

Outcome Measures

Primary Outcomes (1)

• How fast do patients> 60 year reach protective anti-HAV levels after vaccination?

  0, 1,2,3,4 weeks

Study Arms (2)

>60 years

< 40 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 \>60 years, hepatitis A vaccination indicated 40 \< 40 years, hepatitis A vaccination indicated

You may not qualify if:

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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

5 times 7 ml of blood will be collected

MeSH Terms

Conditions

Hepatitis A

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: May 16, 2011
• Study Start: July 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

NL (1)