Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001185752
Ethics application status
Approved
Date submitted
25/08/2022
Date registered
5/09/2022
Date last updated
9/08/2024
Date data sharing statement initially provided
5/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising Q fever vaccination in Australia: Protecting our rural adolescents
Scientific title
Optimising Q fever vaccination in Australia: Protecting our rural adolescents. Safety and immunogenicity of Q fever vaccine (Q-VAX®) in children aged 10 to <15 years.
Secondary ID [1] 307804 0
CTC 0382
Universal Trial Number (UTN)
Trial acronym
Qfevervax1
Linked study record
ACTRN12617000375358 is a pilot for this study.

Health condition
Health condition(s) or problem(s) studied:
Q Fever 327390 0
Condition category
Condition code
Infection 324512 324512 0 0
Other infectious diseases
Inflammatory and Immune System 324513 324513 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 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.
Intervention code [1] 324266 0
Prevention
Intervention code [2] 324267 0
Treatment: Drugs
Comparator / control treatment
Adult comparator group (>=15 years to <=30 years) to allow for contemporary (same batch/time/place/method) data on outcome measures to be assessed against main study population as part of exploratory study endpoints. Comparator group participants will receive 0.5ml QVax administered subcutaneously and will be monitored for any adverse reaction for 30 minutes post vaccination.
Control group
Active

Outcomes
Primary outcome [1] 332342 0
To measure adverse reactions (local injection site and systemic) to Q fever vaccine in adolescents 10 to <15 years old by the following composite measures:

- Frequency (numbers and percentages) of solicited local reactogenicity AEs after vaccination by severity score, duration and peak severity. Self-reported or identified in medical records.
- Frequency (numbers and percentages) of solicited systemic reactogenicity AEs after vaccination by severity score, duration and peak severity. Self-reported or identified in medical records.
- Frequency (numbers and percentages) of any unsolicited AEs after vaccination. Self-reported or identified in medical records.
- Frequency (numbers and percentages) of any serious adverse events (SAEs). Self-reported or identified in medical records.
- Frequency of any SAEs after vaccination (visit 5). Self-reported or identified in medical records.
- Frequency of any medically attended adverse events (MAAES) after vaccination using MedDRA classification, severity score and relatedness. Self-reported or identified in medical records.
Timepoint [1] 332342 0
- Frequency (numbers and percentages) of solicited local reactogenicity AEs: within 7 days after vaccination.
- Frequency (numbers and percentages) of solicited systemic reactogenicity AEs: within 7 days after vaccination.
- Frequency (numbers and percentages) of any unsolicited AEs: from Day 1 (visit 2) to Day 28-42 (Visit 3) after vaccination.
- Frequency (numbers and percentages) of any serious adverse events (SAEs): from Day 1 (visit 2) to Day 28-42 (Visit 3).
- Frequency of any SAEs: until 12 months after vaccination (visit 5).
- Frequency of any medically attended adverse events (MAAES): from Day 1 to 12 months (visit 5) after vaccination.
Secondary outcome [1] 413104 0
To measure immunogenicity (Q fever antibodies) following Q fever vaccination in children aged 10 to <15 years by the following composite measures:

Derived/calculated endpoints for serum antibody responses specific for Q fever:
- Geometric mean titres (GMTs) of Q fever antibodies post vaccination.
- Proportions seropositive for Q fever antibodies (IgG, IgA, IgM).
Timepoint [1] 413104 0
- Geometric mean titres (GMTs) of Q fever antibodies (IgG, IgA, IgM): at Day 28-42 (visit 3) 6-7 months (visit 4) and 12-13 months (visit 5) post vaccination.
- Proportions seropositive for Q fever antibodies (IgG, IgA, IgM): at day 28-42 (visit 3), 6-7 months (visit 4) and 12-13 months (visit 5).
Secondary outcome [2] 413105 0
To measure the extent to which Q fever antibodies wane in the 12 months post vaccination by the following composite measures:

Derived/calculated endpoints for serum antibody responses include:
- Proportions seropositive for different Q fever antibodies (IgG, IgA, IgM) post vaccination.
- GMTs of Q fever antibodies (IgG, IgA, IgM) post vaccination.
Timepoint [2] 413105 0
- Proportions seropositive for different Q fever antibodies (IgG, IgA, IgM): at Day 28-42 (visit 3) 6-7 months (visit 4) and 12-13 months (visit 5) post vaccination.
- GMTs of Q fever antibodies (IgG, IgA, IgM) at 6-7 months (visit 4) and 12-13 months (visit 5) post vaccination.

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

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
Other
Other design features
Comparator group is contemporary, receiving the same product as main study population, and will have their endpoints assessed against the main study population as part of study exploratory endpoints.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size for this phase IV trial is based on practical, logistic, and funding considerations. A risk of severe systemic (grade 3/4) reactions of up to 5.5% has been detected in previous studies in the first month after vaccination and a risk greater than this in those aged 10 to <15 years would raise concerns about use of the vaccine in this age group. With a sample of 900 vaccinated participants we will be able to reject the null hypothesis that the risk of severe systemic reactions is less than or equal to 5.5% if the true risk is 8% or higher with a probability (power) of 90% using a one-sided type 1 error (alpha) probability of 0.05. All participants will have serology performed.

Three analysis datasets will be used for study analyses: Safety Set, modified Intent To Treat (mITT) and Per Protocol. Additional study populations or subgroups of interest may be analysed. The number and percentage of participants in each analysis set will be summarised.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
10/07/2024
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
1100
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23012 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 38327 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 312074 0
Government body
Name [1] 312074 0
Australian Department of Health and Aged Care (Medical Research Future Fund)
Country [1] 312074 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre, University of Sydney,
Medical Foundation Building
92-94 Parramatta Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 313583 0
None
Name [1] 313583 0
Address [1] 313583 0
Country [1] 313583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311482 0
Sydney Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 311482 0
Ethics committee country [1] 311482 0
Australia
Date submitted for ethics approval [1] 311482 0
09/01/2024
Approval date [1] 311482 0
19/01/2024
Ethics approval number [1] 311482 0
2022/ETH00264 - General Amendment ID 150556

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121254 0
A/Prof Nick Wood
Address 121254 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead
NSW 2145
Country 121254 0
Australia
Phone 121254 0
+61 2 98451429
Fax 121254 0
+61 2 9845 1418
Email 121254 0
[email protected]
Contact person for public queries
Name 121255 0
Trial Coordinator
Address 121255 0
NHMRC Clinical Trials Centre, University of Sydney,
Medical Foundation Building
92-94 Parramatta Road, Camperdown NSW 2050
Country 121255 0
Australia
Phone 121255 0
+61 2 9562 5000
Fax 121255 0
Email 121255 0
[email protected]
Contact person for scientific queries
Name 121256 0
Nick Wood
Address 121256 0
The Children's Hospital at Westmead
Cnr Hainsworth St and Hawkesbury Rd
Westmead
NSW 2145
Country 121256 0
Australia
Phone 121256 0
+61 2 98451429
Fax 121256 0
+61 2 9845 1418
Email 121256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified summary or individual participant data.
When will data be available (start and end dates)?
Availability to be determined by Trial Management Committee on request. No end date specified.
Available to whom?
External researchers with appropriate approvals from Trial Management Committee in the presence of a data transfer agreement.
Available for what types of analyses?
Meta or individual participant data analyses.
How or where can data be obtained?
Deidentified data from this study may be available to external researchers where a formal request is lodged and with appropriate approvals. The data custodian will evaluate proposals for additional secondary analyses of this data set and determine the suitability to share relevant de-identified data with these researchers.

Study team can be contacted at:

[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.