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Trial registered on ANZCTR


Registration number
ACTRN12617000374369
Ethics application status
Approved
Date submitted
7/03/2017
Date registered
13/03/2017
Date last updated
22/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of exercise on vaccination responses - the role of timing and site of active muscle
Scientific title
The effects of exercise on vaccination responses in healthy young adults - the role of timing and site of active muscle
Secondary ID [1] 291384 0
Nil known
Universal Trial Number (UTN)
U1111-1193-9619
Trial acronym
STEVax
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccine related adverse events (pain, tenderness, redness, swelling)
 302401 0
Vaccine-related pain
 302402 0
Condition category
Condition code
Other 301974 301974 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised (by computer randomisation table) into one of four groups: Control (Con), Pre-Vaccination Leg Exercise (PreLeg), Pre-Vaccination Arm Exercise (PreArm) or Post-Vaccination Arm Exercise (PostArm).

The PreArm and PreLeg groups will perform the exercise task and immediately after completion will receive the vaccination. The Con and PostArm groups will receive the vaccination according to standard procedure after a 15-minute resting period. The PostArm group will perform the exercise task immediately after receiving the vaccine while all other groups will rest quietly. The exercise session will be supervised by an experienced trainer.

Exercise tasks: All the participants except for the participants allocated to the Con group will take part in 15- minute exercise. The participant’s allocated to PreArm and PostArm group will partake in a task involving 30 seconds of exercise followed by 30 seconds rest, alternating between 3 upper body exercises (biceps curls, lateral raise, and chest press) using an exercise band. This task has previously been used safely in a study involving young healthy adults, and was shown to increase the immune response to the Pneumococcal vaccine. The task requires minimal, inexpensive equipment, no specialised environment, is easily transportable and implementable and requires no prior exercise experience. The participant allocated to PreLeg group will also partake in a task involving 30 seconds of exercise followed by 30 seconds rest, alternating between 3 lower body exercises (squats, lunges and calf raises).

We will be using Fluquadri Adult, an influenza vaccine of 0.25 mL dose administered intramuscular into the deltoid.
Intervention code [1] 297421 0
Treatment: Other
Intervention code [2] 297429 0
Prevention
Comparator / control treatment
The control group will be administered with 0.25 mL of the influenza vaccine and will sit quietly rested for 15 minutes while others participate in exercise.
Control group
Active

Outcomes
Primary outcome [1] 301388 0
Adverse events (pain, tenderness, redness and swelling) at the site of injection. This will be self-reported using REDCaps online survey tool.
Timepoint [1] 301388 0
For 7 days following.
Primary outcome [2] 301396 0
site-specific vaccine pain using VAS scale
Timepoint [2] 301396 0
immediately after vaccination
Primary outcome [3] 301397 0
antibody response using serology antibody analysis
Timepoint [3] 301397 0
15-minute post vaccination, 1 month and 6 months after vaccination
Secondary outcome [1] 332528 0
Change in pressure-pain threshold with exercise using an algometer
Timepoint [1] 332528 0
within 15 minutes of vaccination

Eligibility
Key inclusion criteria
Eligible adults between the ages of 18 - 30 years, have passed the PAR-Q, and who have not previously received the influenza vaccine in 2016, and have no contraindications to vaccination.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindication to vaccination as listed in the most current Immunisation Handbook, including anyone who has experienced an anaphylactic reaction to any component of the vaccine (including yeast) or following a previous dose of vaccine; history of vaccine related allergies or side-effects; current immune disorder (e.g. glandular fever) or acute infection; pregnant or suspected pregnancy; current medication (e.g., prescription medication, anti-inflammatories); egg allergies; unable to participate in exercise activity screened by PAR-Q.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by
computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A traditional drugs trial analytic strategy will be used. As such, it will firstly be investigated whether there is any difference between treatment and control i.e. exercise groups combined and compared to the control group. Secondly, the treatment groups will be compared i.e. compared within the exercise groups only. As previous studies have found sex differences in intervention efficacy, sex will be entered as a between-subject factor in all parameter analyses. Antibody titres will be log transformed, due to skewed distribution, for statistical analysis as geometric mean concentrations; pain will be assessed as a continuous variable. For adverse event assessment comparison between the exercise and control groups will use the report of adverse events as a categorical variable (Yes/No), differences between groups will be assessed with a Chi squared test. Subsequent analysis will assess severity of adverse events as a continuous variable (t tests).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/03/2017
Actual
24/04/2017
Date of last participant enrolment
Anticipated
28/04/2017
Actual
8/09/2017
Date of last data collection
Anticipated
30/11/2017
Actual
10/10/2017
Sample size
Target
80
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15513 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 295859 0
University
Name [1] 295859 0
The University of sydney
Country [1] 295859 0
Australia
Primary sponsor type
University
Name
The University of sydney
Address
Cumberland campus
75 East street
Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 294720 0
Individual
Name [1] 294720 0
Dr Kate Edwards
Address [1] 294720 0
The University of Sydney
Cumberland Campus,
75 East Street,
lidcombe NSW 2141
Country [1] 294720 0
Australia
Other collaborator category [1] 279469 0
Individual
Name [1] 279469 0
Prof Robert Booy
Address [1] 279469 0
NCIRS
Locked bag 4001, The Children’s Hospital, Westmead, NSW, 2145
Country [1] 279469 0
Australia
Other collaborator category [2] 279470 0
Individual
Name [2] 279470 0
Ass Prof Corinne Caullaud
Address [2] 279470 0
room A014, The University of Sydney,
Cumberland campus,
75 East Street, Lidcombe NSW,2141
Country [2] 279470 0
Australia
Other collaborator category [3] 279471 0
Individual
Name [3] 279471 0
Ms. Jacqueline Fong
Address [3] 279471 0
The University of Sydney, A5.06 MO2, Mallet street, Sydney, NSW 2006
Country [3] 279471 0
Australia
Other collaborator category [4] 279472 0
Individual
Name [4] 279472 0
Vivian Lee
Address [4] 279472 0
The University of Sydney
Cumberland Campus
Rm K121, 75 East Street
Lidcombe, NSW 2141
Country [4] 279472 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297143 0
The University of Sydney Ethics committee
Ethics committee address [1] 297143 0
Ethics committee country [1] 297143 0
Australia
Date submitted for ethics approval [1] 297143 0
20/11/2015
Approval date [1] 297143 0
15/01/2016
Ethics approval number [1] 297143 0
2015/945
Ethics committee name [2] 299708 0
University of Sydney Human Research Ethics Committee
Ethics committee address [2] 299708 0
Ethics committee country [2] 299708 0
Australia
Date submitted for ethics approval [2] 299708 0
20/11/2015
Approval date [2] 299708 0
27/03/2017
Ethics approval number [2] 299708 0
2015/090

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

Contacts
Principal investigator
Name 73114 0
Dr Kate Edwards
Address 73114 0
THE UNIVERSITY OF SYDNEY
Rm K207, Cumberland Campus
75 East STreet
Lidcoombe, NSW 2141
Country 73114 0
Australia
Phone 73114 0
+61 2 9036 7396
Fax 73114 0
Email 73114 0
kate.edwards@sydney.edu.au
Contact person for public queries
Name 73115 0
Vivian Lee
Address 73115 0
THE UNIVERSITY OF SYDNEY
Rm K121, Cumberland Campus
75 East STreet
Lidcombe, NSW 2141
Country 73115 0
Australia
Phone 73115 0
+61 478 708 523
Fax 73115 0
Email 73115 0
vivian.lee@sydney.edu.au
Contact person for scientific queries
Name 73116 0
Vivian Lee
Address 73116 0
THE UNIVERSITY OF SYDNEY
Rm K121, Cumberland Campus
75 East STreet
Lidcombe, NSW 2141
Country 73116 0
Australia
Phone 73116 0
+61 478708523
Fax 73116 0
Email 73116 0
vivian.lee@sydney.edu.au

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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