None listed
Conditions
Brief summary
Australia is on the cusp of a potential outbreak of Japanese encephalitis (JE) viral infections as we move into spring and summer and having back-to-back La Niña seasons. There are effective JE vaccines which are licensed for children over 9 months old and given by subcutaneous (SC) injection. Intradermal (ID) vaccine administration only uses 1/5 of the subcutaneous dose and is therefore “dose sparing” enabling more people to be vaccinated from each vaccine vial. ID JE vaccination has found to be safe and immunogenic in adults, however has not yet been tested in children and adolescents. One recent study suggests that as much as 3% of the Australian population may be at risk of JE virus (JEV) exposure. In a naïve population, the risk of severe disease is likely to be equally distributed between age-groups. Of the 6 JEV deaths recorded in 2022, one was an infant. The aim of this project is to study immunogenicity and safety of JE viral vaccine (Imojev®) given ID using traditional needle and syringe in children and adults and to compare safety and immunogenicity with Imojev® given via the current recommended SC route. The results will be useful to inform vaccination programs if there is a significant JEV outbreak and especially if we have insufficient supplies of JE vaccines in Australia to vaccinate our most at risk populations, including children.
Interventions
Administration of a Japanese encephalitis (JE) vaccine, Imojev, to children aged 5+ years old and adults, either by intradermal or subcutaneous administration under 1:1 randomisation.
The JE vaccine will be administered by trained immunisation nurses in either a hospital/health facility or community venue prepared for the trial.
The JE vaccine contains 4.0-5.8 log plaque forming units of live attenuated recombinant Japanese encephalitis virus per 0.5ml of reconstituted dose.
In the intervent
Administration of a Japanese encephalitis (JE) vaccine, Imojev, to children aged 5+ years old and adults, either by intradermal or subcutaneous administration under 1:1 randomisation. The JE vaccine will be administered by trained immunisation nurses in either a hospital/health facility or community venue prepared for the trial. The JE vaccine contains 4.0-5.8 log plaque forming units of live attenuated recombinant Japanese encephalitis virus per 0.5ml of reconstituted dose. In the intervention group 450 participants in four age-defined cohorts will receive 0.1mL Imojev by intradermal injection using traditional needle and syringe. There will be 4 age cohorts as below 5 to <10 years old n=100 10 to <18 years old n=100 18 to <50 years old n=100 > than or equal to 50 years old n=150 The participant will be monitored for any adverse reaction for 30 minutes post vaccination.
Sponsors
Sydney Children's Hospital Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Potential participants must fulfil all of the following inclusion criteria to be eligible to participate in the study: - Participants aged 5 years or older at the time of consent. - For participants aged 5 to less than 18 years: Parents/ guardians willing and capable of providing written informed consent prior to the performance of any study-specific procedure. OR For participants aged greater than or equal to 18 years: Willing and capable of providing written informed consent prior to the performance of any study-specific procedure - The participant must be in good health as determined by the investigator and/or study nurse, as established by pertinent medical history, physical examination and vital signs assessments performed at Screening. - The participant and parent must be able to attend all scheduled visits and to understand and comply with planned study procedures, in the Investigator’s judgement. - Participant must not meet jurisdictional health department recommendation for JE vaccine to be given SC
Exclusion criteria
If any of the following exclusion criteria apply, the potential participant will not be able to participate in the study: - Participant meets jurisdictional health department recommendation for JE vaccine to be given SC - Known to previously have had JE disease - Known to have lived in a JE endemic area outside Australia for greater than6 months - Previously vaccinated with Imojev® or another JE vaccine - Participant has a contraindication to JE vaccines o anaphylaxis after a previous dose of any JE vaccine o anaphylaxis after any component of a JE vaccine - Previously vaccinated with dengue or yellow fever vaccines, or planning to have these vaccines during the first two months after receipt of the JE vaccine - A history of dengue fever - Pregnant women or planning pregnancy - Breastfeeding or planning to breastfeed - Participant receiving immunosuppressive medication or has medical condition(s) that impaired the normal functioning of the immune system (definitions as per the Australian Immunisation Handbook) - History of any major (per Investigator’s discretion) cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, uncontrolled hypertension and diabetes, clinically significant chronic pulmonary disease, immunological and autoimmune diseases or any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives. - Chronic use (more than 14 continuous days) of any dose of systemic corticosteroids within 30 days prior to Screening. Intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted. - Have (or have a family member who has) had a severe reaction to a live attenuated viral vaccine, or are related to someone with known IFNAR1 deficiency - Have had a severe reaction to the MMR vaccine - History of known or suspected hypersensitivity or any severe allergic reaction including anaphylaxis, generalised urticaria, angioedema, and other significant reaction to Imojev® vaccine or any vaccine component). - Presence of active viral or bacterial infection, with or without fever (oral temperature greater than or equal to 37.8C) at Screening or within 72 hours prior to vaccination, if determined by the Investigator to be of clinical significance (enrolment may be delayed for full recovery if acceptable to the Investigator). - Participating in any other clinical study and have received any other investigational product (i.e. study vaccine, drug, biologic or device) within 30 days or 5 half-lives (whichever is longer) prior to Screening, or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study. - Received or plans to receive a live-attenuated vaccine within 4 weeks before or after each study vaccination - Received immunoglobulins and/or any blood or blood products within 3 months before vaccination or plans to receive any blood or blood products at any time during the study. - Has any psychiatric or cognitive disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
Outcome results
None listed