NCT01386827

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Japanese Encephalitis

Interventions

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

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-07-01
• Last updated: 2011-10-28