Time of day and influenza vaccination study

ISRCTN	ISRCTN70898162
DOI	https://doi.org/10.1186/ISRCTN70898162
Secondary identifying numbers	RG_11-053

Submission date: 19/09/2012
Registration date: 12/11/2012
Last edited: 05/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
It is predicted that by 2020 approximately 1 in 5 of the UK population will be aged 65 or over and that by 2050 this could rise to 1 in 2.5. This increase in life expectancy has not been accompanied by an increase in healthy life expectancy; thus, there is a considerable drive to improve the health of older adults. It has long been recognised that older adults are more at risk of both bacterial and viral infections, prompting the introduction of the annual vaccination programme against influenza for adults aged over 65 years. However, the age-related decline in immune function (immunosenescence) reduces the ability of an older individual to mount a successful vaccination response. With age, the quantity (titre) and quality (affinity) of antibody produced in response to vaccination is reduced. Influenza vaccination of young adults provides 65% - 80% protection against illness whereas vaccination of older adults gives only 30-50% protection. A number of studies have sought to use behavioural interventions, such as an acute aerobic or eccentric weights protocol to improve response to vaccination, but recent observational research has revealed that the timing of vaccination administration may also affect immune response. This study aims to determine whether the time of day (morning vs afternoon) affects antibody response to influenza vaccination. Further, other related factors at the time of vaccination will also be measured as these factors may have an effect upon subsequent antibody response.

Who can participate?
The study involves recruiting over 65 year old males and females from the various surgeries participating in the West Midlands.

What does the study involve?
The participants are divided into two groups (morning vs afternoon vaccination). The study involves having a blood sample prior to annual influenza vaccination, filling out a questionnaire pack and returning for a follow up blood sample 4 weeks later. Anthropometric measurements (height, weight, waist-hip ratio) are also taken. The results of the tests from the two groups are compared.

What are the possible benefits and risks of participating?
Participation in this study helps us to find out whether a simple change in the time of vaccination can help older adults have an improved immune response to vaccination and help protect against influenza. This knowledge could have a big impact upon patient care and medical practice. The only known risk within this study is bruising associated with blood being taken.

Where is the study run from?
The study is being carried out by the School of Sport and Exercise Sciences at the University of Birmingham. However, the participant attends their local GP surgery to have blood samples taken and their influenza vaccination given.

When is the study starting and how long is it expected to run for?
October 2011 to September 2014

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Dr Anna Phillips
a.c.phillips@bham.ac.uk

Contact information

Dr Anna Phillips
Scientific

University of Birmingham
School of Sport and Exercise Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

ORCID ID	0000-0002-5461-0598

Mr Mark Drayson
Scientific

University of Birmingham
School of Sport and Exercise Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

Study information

Study design	Cluster randomised study
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	GP practice
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Time of vaccination and other factors, and response to the annual influenza vaccine in older adults: a cluster-randomised trial
Study objectives	Our proposed study aims to confirm that a simple manipulation of the timing of vaccination will improve the immune response against influenza vaccination in older adults. This will yield an intervention that is easy to implement within the NHS, at little or no added cost. This is an observational study comparing antibody responses to influenza vaccination. Participants are cluster randomised according to their surgery.
Ethics approval(s)	South Birmingham Research Ethics Committee, 04/07/2011, ref: 11/WM/0161
Health condition(s) or problem(s) studied	This study involves aspects of ageing related to the immune response following vaccination
Intervention	The 2 groups (morning vs afternoon vaccination) will be compared. Antibody titres, cytokine levels, sex steroids (cortisol, DHEA, testosterone etc) will be measured at baseline to determine what factors at the time of vaccination may related to antibody response at follow up (4 weeks post vaccine)
Intervention type	Biological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Antibody response
Secondary outcome measures	1. Cytokine levels 2. Sex steroids 3. Psychosocial factors
Overall study start date	01/10/2011
Completion date	01/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	400
Key inclusion criteria	Available to attend surgery for morning (9-11am) or afternoon (3-5pm) vaccination and blood samples, and a fasted morning blood sample one month later.
Key exclusion criteria	No current condition such as cancer, diabetes, chronic fatigue which can affect response to vaccination. No acute infection e.g. a cold. No adverse reactions to blood sampling e.g. fainting.
Date of first enrolment	01/10/2011
Date of final enrolment	10/12/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

West Midlands CRN

B15 2SQ
United Kingdom

North Staffordshire CCG

ST5 1QG
United Kingdom

South Staffordshire CCG

B78 3HF
United Kingdom

Telford & Wreaking CCG

TF7 4BF
United Kingdom

Wolverhampton CCG

WV10 9RU
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

c/o Brendan Laverty
Research and Commercial Services
Institute of Research and Development
Birmingham Research Park
Edgbaston
Birmingham
B15 2SQ
England
United Kingdom

Website	http://www.birmingham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Research council

Medical Research Council - Lifelong Health and Wellbeing Initiative (UK) ref: G1001390
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	To be confirmed at later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/05/2016		Yes	No

Editorial Notes

05/05/2016: Publication reference added.