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

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

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

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

• Elina Erra, MD · Haartman Institute, University of Helsinki

• Lars Lindqvist, MD PhD · Department of infectious diseases Stockholm, Sweden

• Eili Huhtamo, PhD · Haartman Institute, University of Helsinki

• Olli Vapalahti, MD PhD · Haartman Institute, University of Helsinki

• Sari Pakkanen, MSc · Haartman Institute, University of Helsinki

• Sirkka Vene, BMA · Swedish Institute of Infectious Disease Control

• Jukka Riutta, MD · Travel clinic, Postitalo, Lääkärikeskus

• Anu Kantele, MD PhD · Helsinki University Central Hospital

• Lars Rombo, MD PhD · Karolinska Institutet

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2011-04-30

Completion

2011-04-30