Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis

Japanese Encephalitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386827
• Other study ID #: 382/E7/07
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2011
• Last updated: October 27, 2011
• Start date: January 2008
• Est. completion date: April 2011

Study information

• Verified date: October 2011
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

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
• 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
• C) primary immunizations with Ixiaro
2 0.5 ml doses of Ixiaro 28 days apart
• S) Ixiaro booster to MBJEV primed
0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody titers 1 month after last vaccine dose	Determination of antibody titers 1 month after last vaccine dose	1 month	No
Secondary	Antibody titers two years after vaccination	Measurement of antibody titers two years after vaccination	2 years	No