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NCT Number: NCT01386827

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

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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Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Other names: Korean Green Cross

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

Other names: Korean Green Cross

C) primary immunizations with Ixiaro

Biological

2 0.5 ml doses of Ixiaro 28 days apart

Other names: Ixiaro

S) Ixiaro booster to MBJEV primed

Biological

0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV

Other names: Ixiaro

Primary outcomes

  1. Antibody titers 1 month after last vaccine dose

    Time frame: 1 month

    Determination of antibody titers 1 month after last vaccine dose

Secondary outcomes

  1. Antibody titers two years after vaccination

    Time frame: 2 years

    Measurement of antibody titers two years after vaccination

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2011
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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