Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
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Details and patient eligibility
About
The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group.
Full description
The condition under investigation is the naturally aging immune system. The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group.Testing the difference of the JEV-antibody titre increase between young and elderly adults between visit 1 (before booster vaccination) and up to visit 4 (6 months after booster vaccination).
Testing cellular immunity (cytokine production after JEV as well as TBE stimulation) on visit 1, 2 (one week after booster immunisation) and 3 between both age groups.
Testing of surface markers of different T and B cell subsets before and after JE-booster vaccination (on visit 1-3) in comparison between both age groups.
Testing TBE-antibody titres before and after JE-booster vaccination (on visit 1-4) in both age groups.
Testing CMV serology at visit 1 in both age groups.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- participation in the preceeding study "IXIARO®-senescence" (EudraCTno: 2010-018630-52) without protocoll violation OR 2 documented IXIARO® vaccinations 28 days (-8/+ 30 days) apart between January 2010 and April 2014 at the age of 18 to 40 years or above the age of 60.
- good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM)
- willingness to sign written informed consent
major Exclusion Criteria:
- Already received an booster (3rd dose) of IXIARO ®
- Vaccination with other JE vaccine (e.g. Je-vax)
- clinically manifest infection with another Flavivirus within 1 year prior study inclusion (yellow fever, Dengue fever, West Nile, TBE)
- past infection with the JEV
- vaccination against yellow fever, Dengue, West Nile within 6 months prior to study inclusion
- TBE vaccination within the last 30 days prior to study inclusion
- immunosuppressive therapy (intake>14d) within 30 days before IXIARO booster till V3 (day 42+/-4), Corticosteroids like Prednisolon > and = 20mg/day; allowed: topic or inhalative application
- immunodeficiency or st. p. organ transplantation
- autoimmune disease except vitiligo or diseases of the thyroid gland with thyroid hormon substitution therapy
- immuntherapy within 2 weeks before or after Ixiaro Booster
- current acute infection or exacerbation of a chronic illness
- cancer within the last 5 years
- clinically significant haematological, renal, pulmonary, hepatic, neurological, cardiovascular disease which is not treated adequately within 12 weeks before Ixiaro booster
- known infection with HIV, Hep B and Hep C
- Guillain - Barré- Syndrome (GBS) - anamnestic
- anamnestic anaphylaxie, atopy oder severe hypersensivity against ingredients of IXIARO
- drug abuse/alcohol abuse
- pregnancy and breastfeeding
- plasma donation within the last 4 months
- receiving blood or immunglobulins within 3 months before v1
- significant mental disorder
Trial design
Primary purpose
Allocation
Interventional model
Masking
64 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Ines Zwazl, BA; Studien Team
Data sourced from clinicaltrials.gov
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