Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001185651
Ethics application status
Approved
Date submitted
31/10/2014
Date registered
11/11/2014
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a simple exercise intervention on adverse reactions and immune response to Human Papillomavirus (HPV) vaccination
Scientific title
Assessing the effect of 15 mins upper body exercise (using therabands) on the adverse event reporting after HPV vaccination in 11-13 year old boys and girls, compared to usual care.
Secondary ID [1] 285572 0
Nil known
Universal Trial Number (UTN)
U1111-1163-5625
Trial acronym
HEAVE (Hpv vaccination, Exercise and Adverse eVEnts)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HPV vaccination and related local adverse events 293406 0
Prevention of HPV infection 293407 0
Condition category
Condition code
Infection 293688 293688 0 0
Sexually transmitted infections
Alternative and Complementary Medicine 293689 293689 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is a 15 minute exercise task using rubber therabands, administered in small groups with instruction from an exercise scientist. Participants will exercise for 30 seconds followed by 30 seconds rest, rotating between 3 techniques (bicep curls, lateral raises and chest press), and completing 5 x30 seconds of each exercise by the end of the task. Shortly after the completion of the exercise task the vaccine will be administered. The exercise task will be completed before each of the 3 doses of vaccine (baseline, 2 months and 6 months)
Intervention code [1] 290528 0
Behaviour
Intervention code [2] 290557 0
Prevention
Comparator / control treatment
Usual care - resting quietly prior to vaccination.

Both groups will rest quietly for 15 minutes after the vaccination according to usual care.
Control group
Active

Outcomes
Primary outcome [1] 293500 0
Adverse events reported (by diary): Pain and tenderness at the site of the injection (the Toxicity grading scale for vaccines - Mild: mild discomfort to touch, Moderate: Discomfort with movement, Severe: Significant discomfort at rest) redness and swelling (measured in mm).

On each evening for 7 days after vaccination, children will be asked to rate how painful /tender their arm is where they received the vaccination at rest and during movement. Parents will be asked to measure and record any swelling and/or redness with an evaluation card provided. In addition, parents will be asked to record any use of medication, fever, drowsiness, malaise or anorexia in the child.
Timepoint [1] 293500 0
Days 1-7 post vaccination, for each of the 3 vaccine dose (baseline, 2 months, 6 months)
Primary outcome [2] 293501 0
Pain (immediately after vaccination) and during 7 days following vaccination (Wong-Baker FACES Pain Scale- revised)
Timepoint [2] 293501 0
Immediately post each vaccine dose, and once daily for 7 days post each vaccination
Primary outcome [3] 293531 0
Redness and swelling at site of injection (measured in mm) during 7 days following each dose of vaccine
Timepoint [3] 293531 0
Once daily for 7 days post each vacination
Secondary outcome [1] 311179 0
Antibody titre (dried blood spot and serum assays)
Timepoint [1] 311179 0
6 months post first dose of vaccine (immediately prior to receiving dose 3), and 7 months post first dose of vaccine
Secondary outcome [2] 311271 0
Fear of vaccination (The Children's Fear scale)
Timepoint [2] 311271 0
Immediately after each dose of vaccine

Eligibility
Key inclusion criteria
Eligible children are aged 11-13 years, in year 7, have not previously received the HPV vaccine, and have no contraindications to vaccination against HPV. They must provide a signed parental consent form to both participate in the year 7 HPV school vaccination program and to participate in this study. Only participants fluent in English will be considered for participation. This is to ensure that there is good communication between investigators and participants, which will increase patient compliance and the correct completion of exercise task.
Minimum age
11 Years
Maximum age
13 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). Children with thrombocytopenia or any coagulation disorder will also be excluded because bleeding may occur following an intramuscular administration in these individuals. Any condition that prevents vigorous exercise.

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)
On enrollment and receipt of parental consent, children will be allocated the next available study number. Study numbers will be linked to randomised list allocating to Exercise or Control groups. Allocation was concealed by central randomisation by computer, with allocations placed in sealed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomised sequence, separate lists generated for males and females to maintain equal gender balance in groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot data from our previous studies shows that incidence of adverse event reports was lower in exercise groups than controls. In studies using the influenza (N=60) and Hepatitis B (N=78) vaccines, exercise groups reported adverse events significantly less often (15% and 24% respectively) than control groups (45% and 53% respectively). Both these vaccines show far lower rates of adverse events than the HPV vaccine; however, in order to maximize our ability to detect significant differences, we conducted Power calculations predicting a modest 25% difference between groups. Power calculations indicate that expecting a reduction of rate of adverse event reporting of 25% (e.g. 80% in control group and 55% in exercise group), a sample size of 62 per group is necessary. Given that a drop-out rate of >10% from dose 1 to dose 3 is expected, we will recruit N=150 children with N=75 per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2015
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
6/06/2016
Date of last data collection
Anticipated
Actual
20/12/2016
Sample size
Target
150
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290176 0
Charities/Societies/Foundations
Name [1] 290176 0
Financial Markets Foundation for Children
Country [1] 290176 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney,
Faculty of Health Sciences,
PO Box 170
Lidcombe, NSW, 1825
Country
Australia
Secondary sponsor category [1] 288887 0
Other Collaborative groups
Name [1] 288887 0
National Centre for Immunisation Research and Surveillance
Address [1] 288887 0
NCIRS, Kids Research Institute at The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St, Westmead NSW 2145
Country [1] 288887 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291885 0
University of Sydney HREC
Ethics committee address [1] 291885 0
Ethics committee country [1] 291885 0
Australia
Date submitted for ethics approval [1] 291885 0
28/11/2014
Approval date [1] 291885 0
03/03/2015
Ethics approval number [1] 291885 0
Ethics committee name [2] 302019 0
Sydney Children’s Hospital Network Human Research Ethics Committee
Ethics committee address [2] 302019 0
Ethics committee country [2] 302019 0
Australia
Date submitted for ethics approval [2] 302019 0
20/03/2015
Approval date [2] 302019 0
01/04/2015
Ethics approval number [2] 302019 0
HREC/15/SCHN/107

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

Contacts
Principal investigator
Name 52422 0
Dr Kate Edwards
Address 52422 0
Exercise Health and Performance Research Group
University of Sydney, Cumberland Campus
PO Box 170
Lidcombe, NSW, 1825
Country 52422 0
Australia
Phone 52422 0
+61 2 9036 7396
Fax 52422 0
Email 52422 0
[email protected]
Contact person for public queries
Name 52423 0
Kate Edwards
Address 52423 0
Exercise Health and Performance Research Group
University of Sydney, Cumberland Campus
PO Box 170
Lidcombe, NSW, 1825
Country 52423 0
Australia
Phone 52423 0
+61 2 9036 7396
Fax 52423 0
Email 52423 0
[email protected]
Contact person for scientific queries
Name 52424 0
Kate Edwards
Address 52424 0
Exercise Health and Performance Research Group
University of Sydney, Cumberland Campus
PO Box 170
Lidcombe, NSW, 1825
Country 52424 0
Australia
Phone 52424 0
+61 2 9036 7396
Fax 52424 0
Email 52424 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?
Raw data available on request after publication requirements fulfilled
When will data be available (start and end dates)?
To be determined dependent on publication
Available to whom?
Researchers who request data from PI
Available for what types of analyses?
Systematic review / meta analysis
How or where can data be obtained?
email to PI


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
421Ethical approval    367341-(Uploaded-22-11-2018-15-05-33)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of exercise on local and systemic adverse reactions after vaccinations - Outcomes of two randomized controlled trials.2018https://dx.doi.org/10.1016/j.vaccine.2018.09.067
EmbaseThe effect of exercise on vaccine-related pain, anxiety and fear during HPV vaccinations in adolescents.2018https://dx.doi.org/10.1016/j.vaccine.2018.04.069
N.B. These documents automatically identified may not have been verified by the study sponsor.