Japanese Encephalitis
Conditions
Keywords
Ixiaro, japanese encephalitis vaccine, booster
Brief summary
The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro. Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune responses in four groups: A) primary immunization with BMJEV, B) primary and secondary immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of serum samples collected before and after vaccination.
Interventions
BIOLOGICALMouse brain derived japanese encephalitis vaccine (MB-JEV)
a) 2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 immunization and one booster dose of Ixiaro 0.5 ml \> 2 years later
BIOLOGICALPrimary and booster immunizations with MB-JEV
2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 as primary immunization and one booster dose of 0.5 ml \> 2 years later
BIOLOGICALC) primary immunizations with Ixiaro
2 0.5 ml doses of Ixiaro 28 days apart
BIOLOGICALS) Ixiaro booster to MBJEV primed
0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV
Sponsors
Karolinska Institutet
Helsinki University Central Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female travellers ≥ 18 years of age. * General good health. * Written informed consent. * Ability to attend all visits scheduled in this study. * Travellers who have previously got a primary vaccination series of 2 or 3 doses of JE-MB and now receive a booster vaccination , either MB-JEV or IXIARO, at the travel clinic for their journey to Asia, OR * Travellers with no previous vaccination against JE who are given the primary vaccination series with IXIARO at a travel clinic prior to their journey to Asia.
Exclusion criteria
* \- \< 18 years of age. * Acute disease at the time of enrollment. * Pregnancy or lactation. * Known immunodeficiency or immune suppressive treatment. * Any chronic illness that might interfere with the immune response; history of JE. * Alcohol or drug abuse. * Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody titers 1 month after last vaccine dose | 1 month | Determination of antibody titers 1 month after last vaccine dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody titers two years after vaccination | 2 years | Measurement of antibody titers two years after vaccination |
Outcome results
None listed