Primary and booster vaccination in old age: Hepatitis A and Hepatitis B

• Conditions: This study will analyze cellular and humoral immune reponses after primary or booster vaccination against HAV and HBV. Healthy adults will be vaccinated with a combination vaccine, which is licensed for all age groups studied in this study; MedDRA version: 16.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 100000004865; MedDRA version: 16.1Level: LLTClassification code 10063436Term: Hepatitis A immunizationSystem Organ Class: 100000004865; MedDRA version: 16.1Level: LLTClassification code 10068384Term: Hepatitis immunizationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-002589-38-AT
• Lead Sponsor: niversität Innsbruck, Institut für Biomedizinische Alternsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-01
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

healthy adults aged 20-40y OR >60y
no prior vaccination against HAV and HBV OR primary vaccination against HAV and HBV more than 10 years ago
based on this information participants will either receive a primary series (3 doses) or a single booster dose of vaccination
signed informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

acute illnes
chronic inflammatory disease (inflammatory bowel disease, Multiple Sclerosis)
chronic infection with HBV, HCV or HIV
transplant recipients
persons who had chemotherapy in the past
persons under immunosuppressive therapy
pregnant women
participation in another trial 4 weeks prior to enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Analysis of the humoral and cellular immune reponse after primary and booster vaccination against HBV and HAV in young (20-40y) and elderly (>60y adults) and to investigate the correlation between cellular and humoral immune responses;Secondary Objective: To identify differences in the impact of age on primary and memory immune responses after vaccination<br>Expression analysis immediately after primary and booster vaccination;Primary end point(s): quantification of vaccine-induced immune response 6 months after the last dose of vaccine;Timepoint(s) of evaluation of this end point: 6 months after the last dose of vaccine

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable