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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A) primary immunization with MB-JEV | Active Comparator | Volunteers immunized with MB-JEV |
|
| Primary and booster MBJEV vaccinations | Active Comparator | Booster immunization with MB-JEV of vaccinees primed with MB-JEV |
|
| C) primary immunizations with Ixiaro | Active Comparator | Primary immunization with Ixiaro 2 dose |
|
| S) Ixiaro booster to MBJEV primed | Active Comparator | Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouse brain derived japanese encephalitis vaccine (MB-JEV) | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titers 1 month after last vaccine dose | Determination of antibody titers 1 month after last vaccine dose | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titers two years after vaccination | Measurement of antibody titers two years after vaccination | 2 years |
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Inclusion Criteria:
Male and female travellers ≥ 18 years of age.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elina Erra, MD | Haartman Institute, University of Helsinki | Principal Investigator |
| Lars Lindqvist, MD PhD | Department of infectious diseases Stockholm, Sweden | Principal Investigator |
| Eili Huhtamo, PhD | Haartman Institute, University of Helsinki | Principal Investigator |
| Olli Vapalahti, MD PhD | Haartman Institute, University of Helsinki | Principal Investigator |
| Sari Pakkanen, MSc | Haartman Institute, University of Helsinki | Principal Investigator |
| Sirkka Vene, BMA | Swedish Institute of Infectious Disease Control | Principal Investigator |
| Jukka Riutta, MD | Travel clinic, Postitalo, Lääkärikeskus | Principal Investigator |
| Anu Kantele, MD PhD | Helsinki University Central Hospital | Study Director |
| Lars Rombo, MD PhD | Karolinska Institutet |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22696017 | Derived | Erra EO, Askling HH, Rombo L, Riutta J, Vene S, Yoksan S, Lindquist L, Pakkanen SH, Huhtamo E, Vapalahti O, Kantele A. A single dose of vero cell-derived Japanese encephalitis (JE) vaccine (Ixiaro) effectively boosts immunity in travelers primed with mouse brain-derived JE vaccines. Clin Infect Dis. 2012 Sep;55(6):825-34. doi: 10.1093/cid/cis542. Epub 2012 Jun 13. |
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|
| Primary and booster immunizations with MB-JEV | Biological | 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 |
|
|
| C) primary immunizations with Ixiaro | Biological | 2 0.5 ml doses of Ixiaro 28 days apart |
|
|
| S) Ixiaro booster to MBJEV primed | Biological | 0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV |
|
|
| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D007117 | Immunization, Secondary |
| ID | Term |
|---|---|
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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