None listed
Conditions
Brief summary
Q fever is a highly infectious disease caused by the bacteria Coxiella burnetii. Currently there is an effective 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 only vaccine available in the world is Q-VAX®, which is, according to the Australian Immunisation Handbook, only recommended for people aged 15 years or over, and therefore 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. This is a Phase IV, multi-centre, vaccine trial in which 1000 children, aged 10 to <15 years, and 100 adults (aged >=15 to <=30 years) will be recruited across NSW and Queensland. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of the licensed Q fever vaccine (Q-VAX®) in children aged 10 to < 15 years.
Interventions
Administration of Q fever vaccine to children aged 10 to 14 years and 364 days old. The Q fever vaccine will be administered by trained immunisation nurses in either a hospital/community health setting. The vaccine is given subcutaneously. The subject will be monitored for any adverse reaction for 30 minutes post vaccination. The vaccine 0.5ml QVax is only given once.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
10 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
For participants Aged >=15 to <=30 years (young adult cohort): 1. Willing and capable of providing written informed consent prior to the performance of any study-specific procedure: for participants Aged >=15 to <=30 years. OR For participants ages 10 to <15 years (adolescent cohort): 2. Parents/ guardians willing and capable of providing written informed consent prior to the performance of any study-specific procedure. 3. Aged 10 to <15 years (adolescent cohort) or Aged >=15 to <=30 years (young adult cohort) at the time of consent. 4. 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. 5. The participant must be negative for both Q fever serology and skin test conducted at screening visit prior to vaccination. 6. 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.
Exclusion criteria
1. 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. 2. History of / or current egg allergy. 3. Chronic use (more than 14 continuous days) of systemic corticosteroids within 30 days prior to Screening. Intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted. 4. History of any haematological malignancy or active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated). Active is defined as having received treatment within the past 5 years. 5. History of clinically significant neurological disease (excluding simple febrile seizures), demyelinating disease or Guillain Barre syndrome. 6. Eczema or other significant skin lesion, infection or tattoo at the site of vaccination (left or right upper arm). 7. History of blood dyscrasia or significant disorder of coagulation that, in the opinion of the Investigator, contraindicates IM injection. 8. History of known or suspected hypersensitivity or any severe allergic reaction including anaphylaxis, generalised urticaria, angioedema, and other significant reaction to Q fever vaccine or any vaccine component, including egg protein, thiomersal or residues carried over from manufacture (such as formalin). 9. Presence of active viral or bacterial infection, with or without fever (oral temperature >=37.8 °C) 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). 10. 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. 11. Received or plans to receive a live-attenuated vaccine within 4 weeks before or after each study vaccination. 12. Received or plans to receive an inactivated vaccine within 2 weeks before or after study vaccination. 13. 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. 14. 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. 15. Contraindications to Q fever vaccination as listed in the current NHMRC Australian Immunisation Handbook 10th Edition or as listed in the Q-VAX Product Information. 16. History of medical documentation that supports a previous diagnosis of Q fever infection or history of previous Q fever vaccination. 17. Females known to be or planning on being pregnant at the time of vaccination.
Outcome results
None listed