Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000375358
Ethics application status
Approved
Date submitted
27/02/2017
Date registered
13/03/2017
Date last updated
13/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and immunogenicity of Q fever vaccine in children aged 10 to 15 years.
Scientific title
Safety and immunogenicity of Q fever vaccine in children aged 10 to 15 years.
Secondary ID [1] 291290 0
None
Universal Trial Number (UTN)
Trial acronym
Q fever vaccine safety
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Q fever 302252 0
Condition category
Condition code
Infection 301845 301845 0 0
Other infectious diseases
Inflammatory and Immune System 301846 301846 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297312 0
Prevention
Intervention code [2] 297401 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301267 0
Safety will be assessed using a standardised 7 day diary card completed by both parent and subject. The subject will be asked to record any local reaction and systemic reaction, as well as record their temperature each night for 7 days. telephone contact will be made with the participant 48-72 hours post vaccination.
Safety and reactogenicity: descriptive analyses will be performed on the number, type and severity of local and systemic reactions and severe adverse reactions that occur following vaccination and presented by treatment group.

Timepoint [1] 301267 0
1 month post vaccine
Secondary outcome [1] 332158 0
Immunogenicity serum phase 1 and 2 IgG Q fever antibodies will be measured post vaccination at 3 timepoints; 28-42 days post vaccine, 6-7 months post vaccine and 12-13 months post vaccine
Immunogenicity: An exploratory analysis of seroprevalence by age and time post vaccination will be performed – the analysis will be essentially descriptive.
Timepoint [1] 332158 0
Serum will be collected a t timepoint which is 28 to 42 days post Q fever vaccination, Further serology samples will be collected 6-7 and 12-13 months post Q fever vaccine to assess for longevity of immune responses.

Eligibility
Key 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.
Minimum age
10 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis
Immunogenicity: An exploratory analysis of seroprevalence by age and time post vaccination will be performed – the analysis will be essentially descriptive.

Safety and reactogenicity: descriptive analyses will be performed on the number, type and severity of local and systemic reactions and severe adverse reactions that occur following vaccination and presented by treatment group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7574 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 15465 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 295757 0
Hospital
Name [1] 295757 0
The Children's Hospital at Westmead
Country [1] 295757 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Cnr Hainsworth St and Hawkesbury rds
Westmead
NSW 2145
Country
Australia
Secondary sponsor category [1] 294600 0
None
Name [1] 294600 0
Address [1] 294600 0
Country [1] 294600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297056 0
Sydney Children's Hospitals Network
Ethics committee address [1] 297056 0
Cnr Hainsworth St and Hawkesbury rds
Westmead
NSW 2145
Ethics committee country [1] 297056 0
Australia
Date submitted for ethics approval [1] 297056 0
16/12/2015
Approval date [1] 297056 0
20/06/2016
Ethics approval number [1] 297056 0
HREC/15/SCHN/475

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72830 0
A/Prof Nicholas Wood
Address 72830 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead
NSW 2145
Country 72830 0
Australia
Phone 72830 0
61 2 98451429
Fax 72830 0
61 2 9845 1418
Email 72830 0
[email protected]
Contact person for public queries
Name 72831 0
A/Prof Nicholas Wood
Address 72831 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead
NSW 2145
Country 72831 0
Australia
Phone 72831 0
61 2 9845 1429
Fax 72831 0
62 2 9845 1418
Email 72831 0
[email protected]
Contact person for scientific queries
Name 72832 0
A/Prof Nicholas Wood
Address 72832 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead
NSW 2145
Country 72832 0
Australia
Phone 72832 0
61 2 9845 1429
Fax 72832 0
61 2 9845 1418
Email 72832 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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