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Proposal 646

Title of the Proposed Research

Factors influencing immune response and patient outcomes following influenza vaccination

Lead Researcher

Dr. Subhadra Rajanaidu

Affiliation

Health Protection Research Group, University of Nottingham
Nottingham, UK

Data Sharing Agreement Date

26 September 2013

Lay Summary

Evidence has shown that immune responses and vaccine effectiveness differ based on age groups vaccinated. There is also some evidence to show that cofactors may have influence over the immune response to vaccination. Co factors described include host factors such as demographics, host genetics, co-morbidities and environmental factors [Bruyn, 2010] such as co-infections with other pathogens, exposure to cigarette smoke or other pollutants and nursery school attendance. There is however, limited evidence describing these factors involving influenza vaccination specifically as well as its direct effect on the immune response and vaccine efficacy.

Immunomodulatory drugs such as simvastatin, metformin and glitazones have also been described to have impact on immune responses. A recent assessment on the effect of statin use on the incidence of acute respiratory infections in England suggested that there may be synergism between statins and influenza vaccination.[Fleming, 2010] Hence there is a potential that the use of statins (and perhaps other immunomodulatory drugs) may have an adjuvant like effect on the immune response following influenza vaccination. The influence of these factors following an administration of an adjuvanted influenza vaccine would also provide better understanding of potential uses of immunomodulatory drugs in a seasonal or pandemic flu setting. [Fedson, 2012]

The specific objectives of the project are:
To compare the safety of 2 unfractionated heparin (UFH – a blood thinner) regimens during PCI in high-risk patients with PAD with non–ST-segment elevation acute coronary syndromes (heart attacks) initially treated with fondaparinux.

1. To assess the influence of identified factors ie immunomodulatory drugs, comorbidities and lifestyle factors on immunogenicity following vaccination with an unadjuvanted inactivated trivalent influenza vaccine. This will be stratified by age groups and outlining any immunocompromised states.

2. To assess the influence of identified factors following vaccination with an unadjuvanted inactivated trivalent influenza vaccine on the prevention of influenza, severity of illness, length of illness and complications.

3. To assess the influence of identified factors ie immunomodulatory drugs, comorbidities and lifestyle factors on immunogenicity following vaccination with an adjuvanted inactivated trivalent influenza vaccine. This will be stratified by age groups and outlining any immunocompromised states.

4. To assess influence of identified factors following vaccination with an adjuvanted inactivated trivalent influenza vaccine on the prevention of influenza, severity of illness, length of illness and complications

Study Data Provided

Study BIO106372: Observer-blind superior efficacy trial with GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in elderly subjects
Study BIO109821: Observer blind study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals influenza vaccine GSK576389A administered to adults over 65 years previously vaccinated with the same vaccine, compared to Fluarix™

Funding Source of Research

This research is being conducted part time and does not require additional funding as the datasets are to be obtained without cost and researcher time is being covered through an ongoing employment contract

Potential Conflicts of Interest

Lead Researcher is also currently under employment with GlaxoSmithKline UK PLC and holds company stocks and shares.

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation