Trialling a double-dose of influenza vaccine to examine the efficacy of the influenza vaccination in patients with chronic obstructive pulmonary disease (COPD)

Open label, interventional study of two sequential doses of seasonal influenza vaccination in COPD patients. Initial recruitment of COPD patients via telephone contact will occur onward from January 2018, in readiness for receiving the 2018 seasonal influenza vaccine upon its availability. Study information will then be sent to potential participants via mail prior to their first study clinic visit. COPD patients will provide an initial single blood sample to be analysed of no more than 40 ml, prior to receiving a single, standard-dose (15 ug/strain) of inactivated and purified seasonal influenza vaccine, administered intra-muscularly in the deltoid by a clinical nurse. COPD patients will return 28 days post initial inoculation (p.i.), to provide a second single blood sample of no more 40 ml, prior to receiving a second single, standard-dose (15 ug/strain) of inactivated and purified seasonal influenza vaccine. COPD patients will then attend two further clinic visits to provide blood samples of no more than 40 ml at 56 days, and no more than 10 ml at 84 days post initial vaccine. In 2018, COPD patients will be asked to attend four (4) mandatory study clinic visits, including administration of two sequential, standard, seasonal vaccines delivered 28 days apart. The duration of the first study clinic visit will be approximately two hours in which to complete study screening paperwork, signed consent forms, perform initial lung capacity testing, including a 15 minute period to assess patient reaction to vaccine. Duration of remaining study clinic visits will be approximately 45min, in which to take blood samples and assess patient health, and includes a 15 minute period to assess patient reaction to vaccine on the second visit. Participants will be telephoned to remind them of upcoming clinic visits and research nurses will maintain an attendance log to monitor participant clinic visits for follow up blood collections.