RecruitingPhase 2ACTRN12625000742471

Understanding immune responses to the Yellow Fever (YF) and Japanese Encephalitis (JE) flavivirus vaccines (The FLAVIFLAV Study)

The effect of the order of Japanese Encephalitis and Yellow Fever vaccine administration on Yellow Fever vaccine protection in healthy adults.


Sponsor

The University of Melbourne

Enrollment

88 participants

Start Date

Oct 31, 2025

Study Type

Interventional

Conditions

Summary

Japanese Encephalitis (JE) vaccine and Yellow Fever (YF) vaccine we are using in this study are both “attenuated” vaccines. This means the virus they contain is live but has been weakened and doesn’t cause sickness in healthy people. After JE or YF vaccination, the weakened virus can reproduce itself a little bit for around 1-2 weeks, this makes your immune system start fighting the weakened virus and gives you lasting protection against the disease. The JE vaccine virus has part of the YF virus inside it. If someone is having both vaccines, isn’t known if the order you receive the vaccines changes the immune response to the vaccine viruses. The primary study objective is to assess how the adaptive immune response (responses to antigen) to a live-attenuated JE vaccine impacts the replication of YF virus vaccine following YF vaccination. We will randomise participants to the order in which they receive a YF vaccine and a JE vaccine (JE-YF or YF-JE vaccination arms), given 4 months apart. Participants will have blood samples collected to follow their immune responses to the vaccines.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Yellow Fever and Japanese Encephalitis are both serious mosquito-borne viral diseases, and travellers to affected regions are routinely vaccinated against them. Both vaccines use live but weakened viruses, and interestingly, the Japanese Encephalitis vaccine actually contains a small piece of the Yellow Fever virus inside it. When people receive both vaccines, researchers do not yet fully understand whether the order of vaccination affects the strength of the immune response to each. This study will randomly assign healthy participants to receive the two vaccines four months apart — either Yellow Fever first or Japanese Encephalitis first — and will collect blood samples at regular intervals to track how the immune system responds and whether the order makes a difference. This knowledge could help improve vaccination schedules for travellers. This study is for healthy adults aged 18 to 60 who have never had either vaccine before and are willing to have blood drawn on multiple occasions. People with immune conditions, pregnancy, a history of thymus disease, or a severe egg allergy are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Yellow Fever (YF) vaccine and Japanese Encephalitis (JE) vaccine. Participants will be randomised to the order in which they receive a YF vaccine and a JE vaccine (JE-YF or YF-JE vaccination arms), g

Yellow Fever (YF) vaccine and Japanese Encephalitis (JE) vaccine. Participants will be randomised to the order in which they receive a YF vaccine and a JE vaccine (JE-YF or YF-JE vaccination arms), given 4 months apart. YF vaccine - 0.5 mL single dose of reconstituted vaccine given by intramuscular or subcutaneous injection. JE vaccine - 0.5 mL single dose of the reconstituted vaccine given by intramuscular injection to the deltoid region of the upper arm Adherence to vaccine order will be monitored by audit of case report files and REDCap


Locations(1)

VIC, Australia

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ACTRN12625000742471


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