Condition category
Not Applicable
Date applied
19/09/2012
Date assigned
12/11/2012
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.birmingham.ac.uk/

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

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27129425

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added.