None listed
Conditions
Brief summary
Summary: Q fever is a highly infectious disease caused by Coxiella Burnettii. Each year in Australia there are over 450 cases notified, (2013 n= 485, 2014 n=452). This equates to approximately 8-10 cases per week. Currently there is an efficacious Q fever vaccine which is recommended for those considered to be in “occupational at risk” groups, such as abattoir workers, veterinarians and farmers. However, several recent studies have highlighted that the risk in the non-traditional “at risk” groups, such as children, metropolitan dwellers, is higher than previously thought. The epidemiology of Q fever disease in New South Wales has changed and amongst notified cases the relative importance of non-abattoir contact with livestock, wildlife or feral animals appears to be increasing. Importantly the only vaccine available in the world is QVax, manufactured by CSL and is only licensed for those over 15 years old. Therefore under current Australian Immunisation guidelines children under 15 years old, who are at risk of contracting Q fever, because they live on farms, near abattoirs or, are children of “at risk” workers cannot be vaccinated. The main reason for this age restriction is not because of an identified safety risk but because the initial trials did not include children under 15 and therefore restricted the licensure of the vaccine. Vaccinating children, particularly children of farmers or animal breeders, is an important preventive measure and has not been studied at all. In this pilot study the safety and efficacy of Q fever vaccine in children aged 10 to 15 years old will be measured.
Interventions
Administration of Q fever vaccine to children aged 10 to 14 years old. The Q fever vaccine will be administered by trained immunisation nurses in either a hospital/community health setting or at home. The vaccine is given intramuscularly. The subject will be monitored for any adverse reaction for 15 minutes post vaccination. The vaccine 0.5ml QVax is only given once.
Sponsors
The Children's Hospital at Westmead
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
10 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
Children who are between 10 years and 14 years 364 days old are eligible to participate in this study. Eligible children must meet inclusion and exclusion criteria at the time of first visit and parents/guardians must give written informed consent. Vaccination will be deferred in children who are eligible but have 1. Acute disease at the time of vaccination, which may include conditions, which in the opinion of the treating physician warrant investigation and/or treatment with fever defined as axillary temperature greater than 38 degrees Celsius 2. Receipt of a live attenuated vaccine within 30 days of visit 1 or receipt of an inactivated vaccine within 14 days of visit 1.
Exclusion criteria
Subject exclusion criteria: 1.. Contraindications to Q fever vaccination as listed in the current NHMRC Australian Immunisation Handbook 10th Edition or as listed in the QVax Product Information. 2. Q fever vaccine will not be administered to any individual with any history of egg allergy 3. Q fever vaccine will not be administered to individuals known to be hypersensitive to any component of the vaccine, including egg protein, thiomersal or residues carried over from manufacture (such as formalin). 4. Administration of immunoglobulins and any blood products within the 3 month period prior to the first visit; in which case, a delay in enrolment will be considered in the absence of other excluding criteria. 5, Positive pre-vaccine screening on serology or skin test (see above) 6. Any confirmed or suspected immunosuppressive or immunodeficient condition contraindicating MMR vaccination. 7. History of serious chronic illness or condition which in the judgement of the clinical investigator would preclude study participation. 8. History of neurologic disease or seizure (excluding simple febrile seizure). 9. Must not have had a Q fever vaccination 10. History of medical documentation that supports a previous diagnosis of Q fever 11. Pregnancy
Outcome results
None listed