Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis
This study has been completed.
Sponsor:
Helsinki University Central Hospital
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Anu Kantele, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01386827
First received: June 30, 2011
Last updated: October 27, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Japanese Encephalitis |
Biological: Mouse brain derived japanese encephalitis vaccine (MB-JEV) Biological: Primary and booster immunizations with MB-JEV Biological: C) primary immunizations with Ixiaro Biological: S) Ixiaro booster to MBJEV primed |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Ability of the New Vero-cell-derived Inactivated Japanese Encephalitis Vaccine (IXIARO) to Elicit a Booster Response in Travellers Previously Vaccinated With Traditional Mouse-brain Derived Vaccine (JE-MB) |
Resource links provided by NLM:
Further study details as provided by Helsinki University Central Hospital:
Primary Outcome Measures:
- Antibody titers 1 month after last vaccine dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]Determination of antibody titers 1 month after last vaccine dose
Secondary Outcome Measures:
- Antibody titers two years after vaccination [ Time Frame: 2 years ] [ Designated as safety issue: No ]Measurement of antibody titers two years after vaccination
| Enrollment: | 120 |
| Study Start Date: | January 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A) primary immunization with MB-JEV
Volunteers immunized with MB-JEV
|
Biological: Mouse 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
Other Name: Korean Green Cross
|
|
Active Comparator: Primary and booster MBJEV vaccinations
Booster immunization with MB-JEV of vaccinees primed with MB-JEV
|
Biological: Primary 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
Other Name: Korean Green Cross
|
|
Active Comparator: C) primary immunizations with Ixiaro
Primary immunization with Ixiaro 2 dose
|
Biological: C) primary immunizations with Ixiaro
2 0.5 ml doses of Ixiaro 28 days apart
Other Name: Ixiaro
|
|
Active Comparator: S) Ixiaro booster to MBJEV primed
Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV
|
Biological: S) Ixiaro booster to MBJEV primed
0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV
Other Name: Ixiaro
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386827
Sponsors and Collaborators
Helsinki University Central Hospital
Karolinska Institutet
Investigators
| Principal Investigator: | 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 |
| Study Director: | Anu Kantele, MD PhD | Helsinki University Central Hospital |
| Study Director: | Lars Rombo, MD PhD | Karolinska Institutet |
More Information
No publications provided by Helsinki University Central Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anu Kantele, Associate professor, Helsinki University Central Hospital |
| ClinicalTrials.gov Identifier: | NCT01386827 History of Changes |
| Other Study ID Numbers: | 382/E7/07 |
| Study First Received: | June 30, 2011 |
| Last Updated: | October 27, 2011 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by Helsinki University Central Hospital:
|
Ixiaro japanese encephalitis vaccine booster |
Additional relevant MeSH terms:
|
Encephalitis Encephalitis, Japanese Encephalitis, Arbovirus Encephalitis, Viral Central Nervous System Viral Diseases Virus Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Arbovirus Infections RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 21, 2013