Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anna Phillips
ORCID ID
http://orcid.org/0000-0002-5461-0598
Contact details
University of Birmingham
School of Sport and Exercise Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
Type
Scientific
Additional contact
Mr Mark Drayson
ORCID ID
Contact details
University of Birmingham
School of Sport and Exercise Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RG_11-053
Study information
Scientific title
Time of vaccination and other factors, and response to the annual influenza vaccine in older adults: a cluster-randomised trial
Acronym
Study hypothesis
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
South Birmingham Research Ethics Committee, 04/07/2011, ref: 11/WM/0161
Study design
Cluster randomised study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
Antibody response
Secondary outcome measures
1. Cytokine levels
2. Sex steroids
3. Psychosocial factors
Overall trial start date
01/10/2011
Overall trial end date
01/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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.
Recruitment start date
01/10/2011
Recruitment end date
10/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
West Midlands CRN
B15 2SQ
United Kingdom
Trial participating centre
North Staffordshire CCG
ST5 1QG
United Kingdom
Trial participating centre
South Staffordshire CCG
B78 3HF
United Kingdom
Trial participating centre
Telford & Wreaking CCG
TF7 4BF
United Kingdom
Trial participating centre
Wolverhampton CCG
WV10 9RU
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
c/o Brendan Laverty
Research and Commercial Services
Institute of Research and Development
Birmingham Research Park
Edgbaston
Birmingham
B15 2SQ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council - Lifelong Health and Wellbeing Initiative (UK) ref: G1001390
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
To be confirmed at later date
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27129425